Those who are willing to apply for Waiver of registration for Medical Device please be kindenough to submit your properly filled application form and relevant documents to office of Sate Ministry of Production, Supply and Regulations & Pharmaceuticals.
Download WOR Application from here :WOR Application
Documents Required for Waiver of Registration.
- Request Letter from the Applicant
- Completed Waiver of Registration Application
- Commercial invoice / Proforma Invoice
- Letter of Authorization from the manufacturer
- Product Information Leaflet / Catalogs
- Labels of the product
- Relevant Test Reports for the Applied Product
- Free sale Certificate issued by Health Authority of Country of Origin of the Product
- ISO certificate for quality management system
- CE self-declaration by manufacturer/ EC certificate for full Quality Assurance system
- Report of Technical Evaluation Committee (TEC)
- Approval of Procurement Committee
Mandatory Documents
- Agency transfer letter issued by NMRA
- Sample import license issued by NMRA
- Certificate of Registration issued by NMRA
- Registration of Medical Council – Sri Lanka
- Ethic review committee approval(Applicable for research items)
- No Objection Letter (NOL) from local agent – (For the products already registered to another Local Agent)
- Sri Lanka Custom Detained Document
- Recommendation of Professional bodies
- Request of Professional bodies
Where Applicable
Note: Incomplete application will not be tabled to WOR Committee.
Waiver of Registration Committee - Device 05/12/2023 |
|||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Recommendation |
01 |
22/11/2023 |
MD/1858/11/2023 |
Reagent for Hematology Analyzer |
As per the invoice |
10043701, date: 18/08/2023 , 10043702, date: 18/08/2023 |
33,515.00 + 1,370.00 |
Hemas Surgicals & Diagnostics (Pvt) Ltd |
Nihon Kohden - Japan |
For Sri Lanka Air Force |
Registered Manufacturer with NMRA. Requested to import reagents and controls for already installed Nihon Kohden analyzers in Air force hospitals. |
Recommended with condition. Advised to submit the dossier for registration within 03 months. |
02 |
22/11/2023 |
MD/1861/11/2023 |
Active Surgicals Power Tools, Blade & Burs for General Surgery (Brand: ConMed) |
12 |
4275735, date: 25/10/2023, 4276228, date: 26/10/2023, 4277758, date: 27/10/2023, 4280668, date: 31/10/2023 |
959.00+1113.00+13608.00+1694.00 |
Hemas Surgicals & Diagnostics (Pvt) Ltd |
Leagal - ConMed Corporation - USA, Physical - Linvatec Corporation d/b/a ConMed Linvatec - USA |
For Lanka Hospital Diagnostics |
Previously registered product with Zodiac Medicals & Agency transferred to Hemas Surgicals. Applied for Sample Import License on 14.11.2023 to NMRA. |
Recommended with condition. Advised to submit the dossier for registration. |
03 |
22/11/2023 |
MD/1859/11/2023 |
Anti-Human IgG (H+L), highly cross adsorbed-Peroxidase antibody produced in goat (Brand: Sigma) (Model: SAB3701361-1MG) |
1 |
8206451278, date: 15/11/2023 |
EUR 382.00 |
Neochem Lifesciences (Pvt) Ltd |
Sigma Aldrich - Germany |
For Faculty of Medicine, University of Colombo |
Manufacturer is not registered with NMRA. Request for research purpose from University of Colombo. |
Recommended only for this consignment. |
04 |
22/11/2023 |
MD/1860/11/2023 |
QClamp PIK3CA Mutation Detection Test (30 Samples) |
2 |
103023AP, date: 30/10/2023 |
USD 1,440.40 |
Tharini Cabraal, Faculty of Science, University of Colombo |
Diacarta Inc - United States of America |
For Research |
Manufacturer is not registered with NMRA. Request for an undergraduate research of University of Colombo. |
Recommended only for this consignment. |
05 |
04/12/2023 |
MD/1874/12/2023 |
Computed Tomography System / CT Scanner with standard Accessories and Spare Parts |
1 |
Z448710, date: 22/11/2023 |
Yen 20,200.00 |
Mediquipment Limited |
Canon Medical Systems Corporation - Japan |
For Teaching Hospital - kurunegala |
Previously registered product with NMRA. (Alexion CT Scanner) and discontinued the model. Request to supply Spare Parts for installed Alexion Series CT Scanner - TH - Kurunegala. |
Recommended only for this consignment. |
06 |
04/12/2023 |
MD/1875/12/2023 |
Sterilizer System and Standard Accessories and Spare Parts |
As per the invoice |
8085414695, date: 28/11/2023 |
USD 22,430.94 |
Mediquipment Limited |
Getinge Sterilization AB - Sweden |
For Sri Lanka Covid 19 Emergency Response and Health Systems Preparedness Project |
Registered Product with NMRA. Request to supply Spare Parts for HS-66; discontinued model. |
Recommended only for this consignment. |
07 |
30/11/2023 |
MD/1868/11/2023 |
Human Cys-C (Cystain C) ELISA Kit, Human BMG/B2-MG ( Beta-2-Microglobulin) ELlSA Kit, Human KIM-1 (Kidney Injury Molecule 1) ELISA Kit, Human AMBP Elisa Kit, Human NGAL ELISA kit |
4+4+4+4+4 |
ED20231121SRA, date: 21/11/2023 |
U$ 4,212.00 |
Biomedite (Pvt) Ltd |
Wuhan Elabscience Biotechnology Co.Ltd - China |
For University of Sri jayawardenepura (Research Purpose) |
Manufacturer is not registered with NMRA. No registered Sources available. |
Recommended only for this consignment. |
08 |
30/11/2023 |
MD/1866/11/2023 |
Dental Imaging System , Fire CR dental reader with accessories & Spare Parts |
As per the invoice |
TD-231023-D10+3 , date: 09./11/2023 |
$28,660.00 |
Access International (Pvt) Ltd |
Digiray Corp - Korea |
For the Department of Health Services - Southern Province and Eravur Multi Purpose Co-Operative Society Ltd |
Applied for product registration. (D-5038) on 24/10/2023. |
Not recommended. Advised to expedite the registration. |
09 |
14/11/2023 |
MD/1828/11/2023 |
Medical Devices/Equipments |
As per the invoice |
SO-019210, date: 01/11/2023 |
USD 103,787.30 |
Ministry of Health |
Imres b.v - Netherland. |
Donation from United Nations Population Fund to government of Sri Lanka |
|
Recommended only for this consignment. (For device only) |
10 |
15/11/2023 |
MD/1829/11/2023 |
Vaccine Refrigerator (With Voltage Stabilizer / Spare Parts |
50 + 5 |
SWW9015945, date: 14/11/2023 |
USD 70,050.00 |
Ministry of Health |
Qingdao Haier Biomedical Co.ltd - China |
Donation from United Nations International Children's Emergency Fund to government of Sri Lanka |
|
Need proper details and documents. |
11 |
25/10/2023 |
MD/1795/10/2023 |
Bioline LF FTS (Filariasis Test Strips) Kits |
600 PCS |
AWB No: 6485593833, date: 10/11/2023 |
USD 3421.98 |
Ministry of Health |
World Health Organization - Dilhi |
Donation to Anti Filariasis Campaign |
|
Recommended only for this consignment. |
12 |
17/11/2023 |
MD/1840/11/2023 |
Indicating FTA Classic Card Pack of 25. Origin UK (HS Code 48239085) |
76 |
258278, date: 23/10/2023 |
USD 11,979.88 |
Ministry of Health |
Camlab Limited - UK |
Donation to government of Sri Lanka |
|
Recommended only for this consignment. |
13 |
21/11/2023 |
MD/1845/11/2023 |
Medical Devices/Equipments |
As per the invoice |
HSC/USAWAS/2301, date: 01/11/2023 |
$1,124.00 |
Ministry of Health (Hospital Services Council) |
Hospital Services Council of Greater Washington Area - USA |
Donation |
|
Recommended only for this consignment and advised to submit the distribution list. |
14 |
21/11/2023 |
MD/1846/11/2023 |
Medical Devices/Equipments |
As per the invoice |
HSC/AU/2303, date: 02/11/2023 |
AUD 1,326.55 |
Ministry of Health (Hospital Services Council) |
Hospital Services Council Australia Incorporated - Australia |
Donation |
|
Recommended only for this consignment and advised to submit the distribution list. |
15 |
21/11/2023 |
MD/1847/11/2023 |
Medical Devices/Equipments |
As per the invoice |
00501730360, date: 07/11/2023 |
USD 14,071.20 |
Ministry of Health |
United Nations Children's Fund - Denmark |
Donation |
|
Recommended only for this consignment. |
16 |
21/11/2023 |
MD/1848/11/2023 |
Microplate Washer MW-12A, G-plug, 100-240VAC, Complete set |
6 |
0012623, date: 09/10/2023 |
EUR 13,837.50 |
Ministry of Health |
United Nations Children's Fund - Denmark |
Donation |
|
Recommended only for this consignment. |
17 |
06/11/2023 |
MD/1850/11/2023 |
Fetal Bovine Serum (Brand: Sigma) |
1 |
8206394301, date: 26/07/2023 |
EUR 119.00 |
Prof. S.K.M.K. Harapathdeniya, Faculty of Indigenous Medicine - University of Colombo |
Sigma Aldrich - Germany |
For Research Purpose |
Manufacturer or Local Agent not registered with NMRA. No registered Sources available. |
Recommended only for this consignment. |
18 |
06/11/2023 |
MD1851/11/2023 |
L-Asparagine (Brand: Sigma) |
2 |
8206390169, date: 18/07/2023 |
EUR 434.00 |
Dr. Senathanie Ranasinghe, Coconut Research Institute |
Sigma Aldrich - Germany |
For Research Purpose |
Manufacturer or Local Agent not registered with NMRA MDR Division. No registered Sources available. |
Recommended only for this consignment. |
19 |
23/11/2023 |
MD/1853/11/2023 |
Oxygen Cylinder 15L, Oxygen Cylinder Connector, Oxygen Regulator, BULL Socket |
1050+300+300+150 |
Annex-II |
|
Ministry of Health |
Sri Lanka Embassy in Beijing |
Donation |
|
Pending Decision. Safety should be evaluated prior approval. Advised to submit samples for clinical evaluation. |
20 |
30/11/2023 |
MD/1867/11/2023 |
FTA Cards |
76 |
258278, date: 23/10/2023 |
USD 111,979.88 |
Medical research Institute |
World Health organization - Malaysia |
Donation to MRI |
|
Recommended only for this consignment. |
21 |
22/11/2023 |
MD/1855/11/2023 |
ICU Hospital Beds |
157 |
19112023, date: 19/11/2023 |
|
Ministry of Health (Mahakaruna Buddhist Society) |
Mahakaruna Buddhist Society - Singapore |
Donation |
|
Recommended only for this consignment and advised to submit the beneficiaries list to the NMRA. |
22 |
22/11/2023 |
MD/1856/11/2023 |
CX33RFS2- Microscope frame for transmitted microscopy with LED illumination, trinocular tube, a pair of eyepiece 10X with helicoid adjustment.. |
10 |
203269556, date: 10/10/2023 |
USD 19,328.00 |
Ministry of Health |
World Health Organization, Global Procurement and Logistics - Malaysia |
Donation from WHO-Malaysia |
|
Pending Decision. Need necessary details prior to approval. |
23 |
24/11/2023 |
MD/1857/11/2023 |
Glucometer Tests Kits |
As per the invoice |
SO-018585, date: 20/07/2023 |
USD 98,420.00 |
Ministry of Health |
Imres b.v - Netherland. |
Donation |
|
Recommended only for this consignment. |
24 |
23/11/2023 |
|
Medical Devices/Equipments |
3 + 3 |
SO-019532, date: 09/08/2023 |
5,119.95 |
Ministry of Health |
Imres b.v - Netherland. |
Donation (Extention) |
|
Recommended the WOR approval extension. |
25 |
16/11/2023 |
|
Female pelvis models and perineum cutting and suture trainer models |
200 PC |
2301802711, date: 05/09/2023 |
17936.83 |
Ministry of Health |
3B Scientific GmbH - Germany |
Donation (Extention) |
|
Recommended the WOR approval extension and advised to submit distribution list. |
26 |
16/11/2023 |
|
Ultrasound, Scanner, digital, portable with printer and accessories |
9 |
288, date: 11/05/2023 |
43200 |
Ministry of Health |
Fazzini - Italy |
Donation (Extention) |
|
Recommended the WOR approval extension. |
27 |
29/11/2023 |
MD/1865/11/2023 |
Goat-Anti-Rat 1gM-UNLB; 1mg |
2 |
Q19815 |
$230.00 |
Prof. Prasanna Galhena, Director, Institute of Biochemistry, Molecular Biology & Biotechnology (IBMBB) |
My BioSource - USA |
For resurch purpose. |
|
Recommended only for this consignment. |
28 |
01/12/2023 |
MD/1871/12/2023 |
Thermo Scientific Block 28x15ml for dry baths and heating blocks replacement |
4 |
EXP-PI-2023/749, date: 22/11/2023 |
USD 40.00 |
Ministry of Health |
Fleischhacker - Singapore |
Donation |
|
Recommended only for this consignment |
29 |
01/12/2023 |
MD/1872/12/2023 |
Scale, mother,child, electronic, 200kg |
30 |
3073656, date: 15/11/2023 |
USD 3,579.90 |
Ministry of Health |
Fleischhacker GmbH & Co.KG - Schwerte |
Donation |
|
Not coming under NMRA purview. (Medical Device) |
30 |
01/12/2023 |
MD/1873/12/2023 |
Re-Conditioned manual wheelchairs complete with cushions, Reconditioned powered wheelcharscomplete with cushions and support seat inserts, Crutches and walking aids |
200 + 10 + 100 |
Equip-Charity-17-2, date: 27/11/2023 |
E 2,375.00 |
The Meththa Rehabilitation Foundation |
The MeththaFoundation - UK |
Donation |
|
Recommended only for this consignment and advised to submit distribution list. |
31 |
04/12/2023 |
MD/1876/11/2023 |
Standard Q Filariasis Antigen Test Kit |
40 Kits |
N/A |
Rs. 2,675,744.80 |
International Organization for Migration |
SD Biosensor Inc - Korea |
For IOM |
Manufacturer is registered with George Steuart Health (Pvt) Ltd for different product. No valid registration for Filariasis test kits. |
Recommended with condition. Subject to submission of product dossier. |
Waiver of Registration Committee - Device 05/12/2023 - S.P.C |
|||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Recommendation |
1 |
06/11/2023 |
MD/1825/11/2023 |
Extention Tube (Brand : 31,745 NOS) |
31,745 |
LP/DHS/RS/RQ/29/552CP/29/22, date: 30/06/2023 |
LKR 3,904,635.00 |
New Arumed (Pvt) Ltd |
Global Medikit Limited - India |
SPC Tender |
Manufacturer is registered with NMRA. |
Pending Decision. Advised to re-evaluate the product with College of Aneasthesiologists of Sri Lanka. |
2 |
27/04/2023 |
MD/1521/05/2023 |
Elastic Adhesive Bandage BP (1993) |
150,000 Roll |
DHS/RS/EP/74/2022, date: 31/03/2023 |
LKR 90,000,000.00 |
Abiman Medical and Surgical Distributors |
Medicare Hygiene Limited - India |
SPC Tender |
Samples are recommended by the College of Surgeon. |
Not Recommended. Due to the availability of many NMRA registered sources. |
3 |
23/10/2023 |
MD/1802/10/2023 |
Cervical Wooden Spatula Ayre type (or Similar) |
350,000 NOS |
LP/DHS/RSS/RQ/293/705DR/2021, date: 09/10/2023 |
LKR 4,987,500.00 |
Marco Lab (Pvt) Ltd |
Jiangsu Hanheng Medical Technology Co.Ltd - China |
SPC Tender |
Manufacturer or Local Agent not registered with NMRA. Submitted to WOR Committee held on 14/11/2023 and Decision was Recommended with condition. Subject to submission of Dossier for product registration. |
Not recommended. Advised to either procure from registered sources or submit the dossier for product registration. |
Waiver of Registration Committee - Device 14/11/2023 |
|||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Recommendation |
1 |
03/11/2023 |
MD/1733/09/2023 |
Radioactive Materials MCD 33VTc-99m Drytec Generator 6GBq |
26 |
CA/108424D/0101/001 (MSD/SB3/R/17/2021) |
USD 39,047.57 |
Medical Supplies Division |
Crown Agents (Sunpro Healthcare) |
For NIU - Lady Ridgway Hospital |
|
Pending Decision. Inform to the Chairman and Refer to MDEC. |
DMSA Agent Mercapton DMSA |
36 Vials |
||||||||||
Bridatec Bromo-Biliaron |
12 Vials |
||||||||||
Mag3 |
36 Vials |
||||||||||
Nanocole |
12 Vials |
||||||||||
2 |
03/11/2023 |
MD/1732/09/2023 |
Radioactive Materials 99m TC Generator |
26 |
CA/108424D/0106/001, date: 05/04/2022 |
USD 64,821.90 |
Medical Supplies Division |
Crown Agents (Sunpro Healthcare) |
For NIU - Karapitiya |
|
Pending Decision. Inform to the Chairman and Refer to MDEC. |
MDP Kits - Skeleton |
16 |
||||||||||
DTPA Kits |
25 |
||||||||||
DMSA Kits |
16 |
||||||||||
Mag 3 Kits |
3 |
||||||||||
Decontamination Kits |
1 |
||||||||||
Quality Control Kits |
25 |
||||||||||
3 |
05/09/2023 |
MD/1751/09/2023 |
Hematology Analyzer (Brand: Abbott) |
2 |
ADD/PF/A668/2023/PAK/GMBH, date: 03/07/2023 |
US $ 24863.00 |
Hemas Surgicals & Diagnostics (Pvt) ltd |
Legal : Abbott Laboratories - USA, Physical : BIT Analytical Instrument GMBH - Germany |
For Hemas Hospital (Pvt) Lyd |
Registered product with NMRA & Valid till 25.01.2024. Autoloader for the analyzer not include in the attachment. Not applied for variation. |
Recommended only for this consignment. Advised to apply for variation. |
4 |
23/10/2023 |
MD/1801/10/2023 |
Spectra Optia Exchange Set/ Spectra Optia IDL Set (Brand: Terumo) |
36 + 150 |
950096931, date: 11/10/2023 |
USD 24,180.00 |
Hemas Surgicals & Diagnostics (Pvt) ltd |
Terumo BCT Inc - USA |
For National Blood Transfusion Services |
NMRA registered product and manufacturing site change. Applied for product registration. (D-4959) |
Not recommended. Expedite the registration. |
5 |
23/10/2023 |
MD/1803/10/2023 |
Adult Velcro Cuff (Brand: Accoson) |
Invoice Qty = 55, RDHS-, Batticaloa purchase order Qty = 50 |
1409, date: 10/08/2023 |
GBP 470.75 |
Esna Allied Enterprises (Pvt) ltd |
A.C.Cossor & Son (Surgical) Ltd - United Kingdom |
For Ragional Directorate of Health Services, Batticaloa |
NMRA registered product and manufacturing site has been changed. Applied for site registration on October 2023. (FMSA/MD/2023/491) Request letter from RDHS - Batticaloa available. |
Recommended only for this consignment. |
6 |
23/10/2023 |
MD/1804/10/2023 |
Swiss Litho Clast Master - Lithotripter System with Standard Accessories |
13+10 |
00011237, date: 25/09/2023 |
EUR 4,202.00 |
Chatham House (Pvt) Ltd |
E.M.S. Electro Medical System S.A, - Switzerland |
Dr. Dimantha De Silva, Snr. Urologist Surgeon, teaching Hospital - Karapitiya / Dr. Niroshan Senevirathne, Sri Jayawardenepura Hospital |
NMRA registered product and expired on 29.06.2023. (D/524) Not applied for the renewal of registration. Around 05 registered sources available. |
Recommended only for this consignment. Subject to submission of Dossier for product registration. |
7 |
30/10/2023 |
MD/1805/10/2023 |
Wheelchairs/ Artificial Limbs / Orthopaedic and diabetic footwear |
866 |
Equip-Charity-17, date: 10/09/2023 |
E 4400.00 |
Meththa Rehabilitation Foundation |
The Meththa Foundation - UK |
Meththa Rehabilitation Foundation |
|
Recommended Only for this consignment. (Recommended Only for Artificial Limbs and Footwear) |
8 |
10/11/2023 |
MD/1810/11/2023 |
Whole Blood donation mixing/Weighing device |
3 pce |
8521886843, date: 10/10/2023 |
EUR 10,350.00 |
Premium International (Pvt) Ltd |
Fresenius Kabi AG - Germany |
Ministry of Health throught New Maternity Hospital - Karapitiya |
|
Not recommended and advised to register the product. |
9 |
10/11/2023 |
MD/1811/11/2023 |
Automated blood component seperator |
As per the invoice |
8521886386, date: 13/09/2023 |
EUR 21,500.00 |
Premium International (Pvt) Ltd |
Fresenius Kabi AG - Germany |
Ministry of Health throught New Maternity Hospital - Karapitiya |
|
Not recommended and advised to register the product. |
10 |
10/11/2023 |
MD/1812/11/2023 |
Portable tube seales for high quality seals |
02 PCE |
8521886386, date: 13/09/2023 |
EUR 4,100.00 |
Premium International (Pvt) Ltd |
Fresenius Kabi AG - Germany |
Ministry of Health throught New Maternity Hospital - Karapitiya |
|
Not recommended and advised to register the product. |
11 |
10/11/2023 |
MD/1813/11/2023 |
Manual Plasma Extractor |
2 |
8521886386, date: 13/09/2023 |
EUR 1,760.00 |
Premium International (Pvt) Ltd |
Fresenius Kabi AG - Germany |
Ministry of Health throught New Maternity Hospital - Karapitiya |
|
Not recommended and advised to register the product. |
12 |
10/11/2023 |
MD/1814/11/2023 |
Donation and apheresis Chair |
6.00 pce |
8521886867, date: 12/10/2023 |
EUR 10,950.00 |
Premium International (Pvt) Ltd |
Fresenius Kabi AG - Germany |
Ministry of Health throught New Maternity Hospital - Karapitiya |
|
Not recommended and advised to register the product. |
13 |
10/11/2023 |
MD/1815/11/2023 |
Vertical Autoclave |
1 |
XHC230927003, date: 15/10/2023 |
USD 1275.00 |
Premium International (Pvt) Ltd |
Shinva Medical Instrument Co.Ltd - China |
Ministry of Health throught New Maternity Hospital - Karapitiya |
|
Not recommended and advised to register the product. |
14 |
10/11/2023 |
MD/1816/11/2023 |
Autoclave |
1 |
XHC230927003, date: 15/10/2023 |
USD 1576.00 |
Premium International (Pvt) Ltd |
Shinva Medical Instrument Co.Ltd - China |
Ministry of Health throught New Maternity Hospital - Karapitiya |
|
Not recommended and advised to register the product. |
15 |
10/11/2023 |
MD/1817/11/2023 |
Plasma Thawer with cover |
1 |
8265, date: 21/09/2023 |
E 5,077.00 |
Premium International (Pvt) Ltd |
Helmer Scientific - USA |
Ministry of Health throught New Maternity Hospital - Karapitiya |
|
Not recommended and advised to register the product. |
16 |
10/11/2023 |
MD/1818/11/2023 |
Platelet Incubator (With Accessories) |
4 |
8265, date: 21/09/2023 |
E 11,590.00 |
Premium International (Pvt) Ltd |
Helmer Scientific - USA |
Ministry of Health throught New Maternity Hospital - Karapitiya |
|
Not recommended and advised to register the product. |
17 |
10/11/2023 |
MD/1819/11/2023 |
Tissue embedding system - embedding module & cryo module |
2 sets |
230800130, date: 14/09/2023 |
JPY 700.00 |
Premium International (Pvt) Ltd |
Sakura Seiki Co.ltd - Japan |
Ministry of Health throught New Maternity Hospital - Karapitiya |
|
Not recommended and advised to register the product. |
18 |
10/11/2023 |
MD/1820/11/2023 |
Automated slide stainer with cover slipper (& Link system) |
1 pcs + 2 sets |
230800130, date: 14/09/2023 |
JPY 5,410.00 |
Premium International (Pvt) Ltd |
Sakura Seiki Co.ltd - Japan |
Ministry of Health throught New Maternity Hospital - Karapitiya |
|
Not recommended and advised to register the product. |
19 |
10/11/2023 |
MD/1821/11/2023 |
Slide Warmer |
1 Set |
230800130, date: 14/09/2023 |
JPY 150.00 |
Premium International (Pvt) Ltd |
Sakura Seiki Co.ltd - Japan |
Ministry of Health throught New Maternity Hospital - Karapitiya |
|
Not recommended and advised to register the product. |
20 |
10/11/2023 |
MD/1822/11/2023 |
Water bath round model (Tissue flotation water bath) |
1 Set |
230800130, date: 14/09/2023 |
JPY 210.00 |
Premium International (Pvt) Ltd |
Sakura Seiki Co.ltd - Japan |
Ministry of Health throught New Maternity Hospital - Karapitiya |
|
Not recommended and advised to register the product. |
21 |
13/11/2023 |
MD/1823/11/2023 |
Non-Woven Chesive Bandage and Kinesiology Type |
17552 |
23/66086, date: 23/08/2023 |
USD 6456.69 |
CIC Holdings PLC |
Suzhou Sunmed Co.ltd - China |
|
Manufacturer not registered with NMRA. Not applied for registration. |
Not recommended and advised to register the product. |
22 |
13/11/2023 |
MD/1824/11/2023 |
Capillary Cartridge (Brand: Sebia) |
Invoice Qty : 8, Order Qty : 5 |
FLII012310PRF00000189, date: 23/10/2023 |
EUR 2080.00 |
Analytical Instruments (Pvt) ltd |
Sebia - France |
For several government hospitals in sri lanka ( TH-Kalutara, TH-Batticaloa, NH - Kandy, Base hospital - Kalutara |
|
Not recommended. Advised to apply for Variation. |
23 |
28/08/2023 |
MD/1726/09/2023 |
Hospital Beds (2 Functional Hospital Beds / 3 Function Electric Hospital Beds) |
10 + 1 |
174397547501029504, date: 07/06/2023 |
$1,873.88 |
Suwabawana Hospital |
Beijing Xindalikang Medical Equipment C.ltd - Hong Kong |
For For Suwabawana Hospital Use |
· Manufacturer not registered. · Registered sources available. (05) Submitted to WOR Committee held on 10/10/2023 and Decision was Not recommended and advised to register the product. Advised to purchase from registered sources. |
Not recommended and advised to register the product. Advised to purchase from registered sources. |
24 |
22/09/2023 |
MD/1759/09/2023 |
First Aid Kits Hard Case |
5100 |
UN2399G, date: 09/09/2023 |
$ 27,132.00 |
Omaya International (Pvt) Ltd |
Ningbo Tianbo First Aid Product Co.Ltd - China |
For Michelin Lanka (Pvt) Ltd |
· Manufacturer is not registered with NMRA. To be imported to distribute as gift items among the employees of Michelin Lanka (Pvt) Ltd. Submitted to WOR Committee held on 10/10/2023 and Decision was Not recommended and advised to register the product. |
Not recommended and advised to register the product. |
Waiver of Registration Committee - Device 14/11/2023 - S.P.C |
|||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Recommendation |
01 |
23/10/2023 |
MD/1802/10/2023 |
Cervical Wooden Spatula Ayre type (or Similar) |
350,000 NOS |
LP/DHS/RSS/RQ/293/705DR/2021, date: 09/10/2023 |
LKR 4,987,500.00 |
Marco Lab (Pvt) Ltd |
Jiangsu Hanheng Medical Technology Co.Ltd - China |
SPC Tender |
Manufacturer or Local Agent not registered with NMRA. |
Recommended with condition. Subject to submission of Dossier for product registration. |
02 |
13/07/2023 |
MD/1644/07/2023 |
Root Canal Sealer , Resin Based, for permanant filling of root canal |
4200 |
LP/DHS/S/WW/237/900KP/21, date: 29/06/2023 |
LKR 16,548,000.00 |
Ogaki & Company |
Shiva Products - India |
SPC Tender |
Appeal - Submitted to WOR Committee held on 12/08/2023 and Decision was Not recommended and advised to register the product. Again Submitted to WOR Committee held on 10/10/2023 and Decision was Not recommended and advised to expedite the registration.
|
Recommended Only for this consignment. (At the decision of the College of Dentistry and Stomatology of Sri Lanka. If approved, WOR can be given.) |
Waiver of Registration Committee - Device 10/10/2023 |
|||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Recommendation |
1 |
04/09/2023 |
MD/1750/09/2023 |
Gazue Bandages / Cotton Roll / 100PCS/BAG / Cotton Bandages / Elastic Bandages / Non Women Tape / Zinc Oxide Adhesive Tape |
As per the invoice |
CT23017, date: 21/07/2023 |
US$ 20,836.60 |
Tomahawk Medical (Pvt) Ltd |
Suzhou Courge Trading Co. Ltd - China. |
For a Medical Camp |
· Manufacturer and Local Agent not registered with NMRA. · Registered sources available for all requested products. |
Not recommended and advised to register the product. Advised to purchase from registered sources. |
2 |
04/09/2023 |
MD/1752/09/2023 |
Reagents for Hematology Analyzer |
As per the invoice |
10043701, date: 18/08/2023 , 10043702, date: 18/08/2023 |
USD 33,515.00 + USD 1,370.00 |
Hemas Surgicals & Diagnostics (Pvt) ltd |
Nihon Kohden - Japan |
For Sri Lanka Air Force |
· Registered Manufacturer. · Agency Transfer from TMI Solutions to Hemas Surgicals. · Request to import reagents for installed analyzer. · Previous Ref: no: DVR/9922, DVR/9923, DVR/9924, DVR/9926, DVR/9928 |
Not recommended and advised to expedite the registration. |
3 |
18/09/2023 |
MD/1763/09/2023 |
Spare Parts for Bedside Monitor |
As per the invoice |
10038450, date: 07/06/2023, 10043171, date: 08/07/2023 |
USD 520.00 + USD 29,923.68 |
Hemas Surgicals & Diagnostics (Pvt) ltd |
Nihon Kohden - Japan |
For Faculty of Medicine - University of Kelaniya , Department of Health Services - Northwestern Province |
· Manufacturer and Local Agent registered. · Applied for registration. NMRA Ref: No: D-4694. |
Recommended only for this consignment. |
4 |
21/09/2023 |
MD/1765/09/2023 |
Aortic Valve Repair Kit and Pen |
10 + 10 |
SO-1005, date: 19/07/2023 |
USD 6,930.25 |
Hemas Surgicals & Diagnostics (Pvt) ltd |
Legal : Sanamedi Inc - Japan, Physical : HANTEL Technologies inc - USA |
Department of Cardiothoracic Surgery - Teaching Hospital Kandy. |
· Manufacturer not registered with NMRA. · No registered sources for the product. · Request from Teaching Hospital - Kandy. · Previously WOR was given on 2019. (NMRA/EC/WOR/DVR/105/19) |
Recommended only for this consignment. (Limited Quantity) Advised to apply for registration. |
05 |
03/10/2023 |
MD/1780/10/2023 |
Reagent for Immunoassy Analyzer |
2+3+13 |
ADD/PF/A704/2023/PAK/GMBH - 08/09/2023 |
US $ 6825.00 |
Hemas Surgicals & Diagnostics (Pvt) ltd |
Abbott GmbH - Germany |
For National Hospital of Sri Lanka |
· Registered product with NMRA (Ref: No: D-1620-RR). · Request to Amend the reagent list not submitted to the NMRA. |
Not recommended and advised to apply for certificate amendment. |
06 |
21/09/2023 |
MD/1761/09/2023 |
Orthopeadic Drill System Componentes |
As per the invoice |
20230901PF/01.09.23 |
AED 68,901.17 |
B. Braun Lanka (Pvt) Ltd |
Aesculap AG - Germany |
For several government hospitals. (For NHSL - Colombo, District General Hospital - Polonnaruwa, Sri Jayawardenepura General Hospital, National Hospital - Kandy, Colombo South Teaching Hospital - Kalubovila, District General Hospital - Matale) |
Exported items for repairing. |
Recommended only for this consignment. |
07 |
14/09/2023 |
MD/1764/09/2023 |
Sterilizer - Sterilizer System and Spare Parts, Standard Accessories (Getinge HS 66 Hospital Sterilizer) |
As per the invoice |
8085414114, date: 21/08/2023 |
USD 15,878.16 |
Mediquipment Limited |
Getinge AB - Sweden |
For Base Hospital - Tissamaharama |
· Previously registered product with NMRA. (DVR-11509) · Applying due to the discontinuation of the product by manufacturer and requirement for repair of on installed machine. |
Recommended only for this consignment. |
08 |
03/10/2023 |
MD/1781/10/2023 |
Fetal Monitor with Standard Accessories, Consumables and Spare Parts |
As per the invoice |
NJH23SR-0921-1, date: 21/09/2023 |
USD 2519.00 |
Mediquipment Limited |
Guangzhou Sunray Medical Apparatus Co.Ltd - China |
For General Hospital - Ampara |
· Previously registered product with NMRA & expired. (Ref: DVR-13833) · Manufacturing site changed and applied to the NMRA. (ReF: FMSA/MD/2023/429) · Request to repair the installed machine is available from General Hospital - Ampara. |
Recommended only for this consignment. |
09 |
21/09/2023 |
MD/1766/09/2023 |
Platelet Aggregometer with Standard Accessories & Reagents (helena) Agg RAM) (Brand: Helena) |
As per the invoice |
3545/0012398, date: 30/09/2023 |
E 2,730.49 |
Analytical Instrumets (Pvt) Ltd |
Helena Biosciences Europe - UK |
For Medical Research Institute (Research Purpose) |
· Registered product with NMRA and expired on May 2022. · Not applied for renewal due to the deficiency of documentation. |
Recommended only for this consignment. Advised to apply for renewal. |
10 |
17/08/2023 |
MD/1689/08/2023 |
Orthodontic Bracket (Brand : DAMON Q) |
As per the invoice |
6981004, date: 17/03/2023 |
USD 61,920.00 |
La Solve (Pvt) Ltd |
Ormco Corporation - USA |
For Dental Treatment. (For Dr. Ajith Premaratne, Consultant Orthodontist, Asiri Surgical and Hemas Hospital / Dr. Rathnakumara Dissanayake, Consultant Orthodontists, Sirimavo Bandaranayake Teaching Hospital, Kandy) |
· Sample import license from NMRA issued and Not applied for registration. · 02 registered sources available. |
Not recommended and advised to register the product. |
11 |
28/08/2023 |
MD/1726/09/2023 |
Hospital Beds (2 Functional Hospital Beds / 3 Function Electric Hospital Beds) |
10 + 1 |
174397547501029504, date: 07/06/2023 |
$1,873.88 |
Suwabawana Hospital |
Beijing Xindalikang Medical Equipment C.ltd - Hong Kong |
For For Suwabawana Hospital Use |
· Manufacturer not registered. · Registered sources available. (05) |
Not recommended and advised to register the product. Advised to purchase from registered sources. |
12 |
21/08/2023 |
MD/1698/08/2023 |
ABR Medical PC Platform with spare parts & Accessories (Eclipse) (Model: DPOAE20; TEOAE25; VEMP; ASSR;EP25;IA ONE Suite in one platform) |
1 |
SQ030466, date: 14/08/2023 |
EUR 14,754.00 (USD 16,049.40) |
J.M. Wickramarachchi & Company (Pvt) Ltd |
Interacoustics A/S - Denmark |
For C.R. Medi Tech Lab (Pvt) Ltd, Gampaha) |
· Applied for manufacturing site registration. (NMRA ref: No. FMSA/MD/2023/439) |
Not recommended and advised to register the product. |
13 |
25/09/2023 |
MD/1767/09/2023 |
Sterile Lancet for Single Use |
500,000 PCS |
MD2311, date: 01/09/2023 |
US$ 1,750.00 |
Emex Medical |
Shandong Lianfa Medical Plastic Products Co.Ltd - China |
For a Medical Camp |
· Already registered manufacturer with another local agent for a different product. (Biomedite pvt ltd) · Registered sources available for blood lancets. (More than 15) |
Not recommended and advised to register the product. |
14 |
03/10/2023 |
MD/1782/10/2023 |
Micromanipulation Pipptes (ICSI Pippetes/Holding Pipettes) |
33 |
463430, date: 22/09/2023 |
EUR 0.00 |
A. Baur & Co. (Pvt) Ltd |
Vitrolife Inc - USA |
Re-export |
· Applied for manufacturing site approval and NMRA decision was “awaiting data”. |
Not recommended and advised to expedite the registration. |
15 |
09/10/2023 |
MD/1784/10/2023 |
Surgical Instruments for Workshop |
As per the invoice |
T23-179/181DSW-C, date: 22/09/2023 |
$301,193.49 |
CIC Holding PLC |
Synthes GmbH - Switzerland |
For The Sri Lanka Orthopaedic Association (For Workshop) |
· Surgical Instruments for a Workshop by PGIM. |
Recommended only for this consignment. |
16 |
22/09/2023 |
MD/1759/09/2023 |
First Aid Kits Hard Case |
5100 |
UN2399G, date: 09/09/2023 |
$ 27,132.00 |
Omaya International (Pvt) Ltd |
Ningbo Tianbo First Aid Product Co.Ltd - China |
For Michelin Lanka (Pvt) Ltd |
· Manufacturer is not registered with NMRA. · To be imported to distribute as gift items among the employes of Michelin Lanka (Pvt) Ltd. |
Not recommended and advised to register the product. |
Waiver of Registration Committee - Device 10/10/2023 - S.P.C |
|||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Recommendation |
01 |
06/02/2023 |
MD/1398/02/2023 |
Blood Lancet |
800,000 NOS |
DHS/ICL/X/RL/035/039SM/22, date: 16/01/2023 |
US $ 6,320.00 |
Avon Pharmo Chem (Pvt) ltd |
Labex K.K International - India |
SPC ICL Tender |
· Manufacturing site registration application submitted to NMRA. (FMSA/MD/2023/439 · Recommended by the College of Chemical Pathologists. |
Recommended for the consignment. (recommended by college of Chemical Pathologists.) |
02 |
13/07/2023 |
MD/1644/07/2023 |
Root Canal Sealer , Resin Based, for permanant filling of root canal |
4200 |
LP/DHS/S/WW/237/900KP/21, date: 29/06/2023 |
|
Ogaki & Company |
Shiva Products - India |
SPC Tender |
Appeal - · Manufacturer registered with LW Medicals. All the other products were Agency Transferred to Ogaki & Company. · Other registered sources are available. · Not applied for product registration. Submitted to WOR Committee held on 12/08/2023 and Decision was Not recommended and advised to register the product. |
Not recommended and advised to expedite the registration. |
Waiver of Registration Committee - Device 05/09/2023 |
|||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Recommendation |
1 |
15/08/2023 |
MD/1680/08/2023 |
Medical Devices for Exhibition of the college of surgeons of SriLanka. |
As per the invoice |
91189315, date: 03/08/2023 |
EUR 10,048.28 |
Mega Meditech (Pvt) Ltd |
Gebruder Martin GmbH & Co. KG- Germany |
For Exhibition of the College of Surgeon of Sri Lanka |
· Manufacture and local agent registered with NMRA. · Medical Device exhibition by college of surgeon 2022. · Re export basis. |
Recommended only for this consignment. Advised to re-export after the Exhibition. |
2 |
15/08/2023 |
MD/1685/08/2023 |
CT Tube (Toshiba Aquilion CXL) |
1 Nos |
BMEC/PI-2022-23/7, date: 27/07/2023 |
$49,800.00 |
Delmege Forsyth & Co. Ltd |
Toshiba International Corporation - USA |
Sri Lanka Army. |
|
Recommended only for this consignment Subject to Submit no-objection letters from biomedical engineering services. |
X-Ray Tube with Housing Assembly (MRC20058 rot GS1003) |
1 Nos |
BMEC/PI-2022-23/4, date: 27/07/2023 |
$49,800.00 |
Philips Electronics Nederland B.V - Netherland |
For Biomedical Engineering Services (For NHSL and TH Karapitiya) |
||||||
CT Tube - Philips MRC 600 |
1 Nos |
BMEC/PI-2022-23/5, date: 27/07/2023 |
$49,000.00 |
Philips Electronics Nederland B.V - Netherland |
For Biomedical Engineering Services (For NHSL and TH Karapitiya) |
||||||
X-Ray tube calibration Kits (Dose meter, filter set) |
1 Nos |
BMEC/PI-2022-23/6, date: 27/07/2023 |
$21,600.00 |
Philips Electronics Nederland B.V - Netherland |
For Biomedical Engineering Services (For NHSL and TH Karapitiya) |
||||||
3 |
15/08/2023 |
MD/1664/07/2023 |
Surgery Bed and Infant Radiant Warmer |
01 + 02 |
202306001, date: 29/06/2023 |
USD 210.34 + USD 246.00 |
Senarathna Holdings (Pvt) Ltd |
Zui Bang Hong Kong Limited - China |
For Medihelp Hospital (Pvt) Ltd |
· Manufacturer or local agent not registered with NMRA. · Other registered sources are available for radiant warmers and surgery bed. |
Not recommended and advised to register the product. |
4 |
18/08/2023 |
MD/1686/08/2023 |
Zinc Oxide 110gm , Soothenol Euhenol 15ml, Non-setting Ca(OH2) |
2000 + 2000 + 2000 |
# 222, date: 12/07/2023 |
$6,735.00 |
Oseth Pharmaceuticals |
Dengen Health Care (Pvt) Ltd - India |
For HSEP. (from ADB) |
· Recommended by college of Dentistry and Stomatology |
Recommended only for this consignment. |
5 |
21/08/2023 |
MD/1690/08/2023 |
Dental Chair Unit with Standard Accessories |
5 |
VT20230526, date: 2023/08/08 |
$4,430 |
Reborn Medicom Company (Pvt) Ltd |
Foshan Voten Medical Technology Co.ltd - China |
For dental. (Dr. Sandyanl Amarasingha, Dental Surgeon) |
· Manufacturer Local Agent not registered. · Other registered sources available. |
Not recommended and advised to register the product. |
6 |
21/08/2023 |
MD/1691/08/2023 |
Hemoglobin Analyzer system with standard accessories, spare parts and comsumables (D-10 Hemoglobin Testing System and D-10 printer installation kit.) |
03 + 03 |
BRI/CDG/32/23, date: 17/07/2023 |
USD 33,900.00 |
Emar Pharma (Pvt) Ltd |
Biorad Laboratories - USA. |
For Nawaloka Care Laboratories (manufacturing site Change) |
· Previously registered product and valid till 2027. · Manufacturing site changed. Biorad labor otories - Singapore. · Site registration completed. FMSA/MD/2023/413) |
Recommended only for this consignment. Advised to register the product. |
7 |
21/08/2023 |
MD/1692/08/2023 |
Cryoprotectant for the cryopreservation of human cells and tissues for transplantation. |
10 |
105875, date: 10/08/2023 |
E1,085.00 |
Emar Pharma (Pvt) Ltd |
WAK-Chemie Medical GmbH - Germany |
For Lady Ridgeway Hospital for children |
· No other registered sources. · Previously WOR (NMRA/EC/WO/DVR/317/2022) |
Recommended only for this consignment. Submit the file for registration. |
8 |
18/08/2023 |
MD/1693/08/2023 |
DTPA, MDP Kits, DMSA |
120 + 120 + 60 |
CA/108424D/0123/001, 15/05/2023 |
Euro 10,771.19 |
Medical Supplies Division |
National Centre for Nuclear Research Radiostope Center POLATOM - Poland |
For MSD (For NMU - Peradeniya) (Not a donation) |
· No other registered sources for importing radioactive materials. |
Recommended only for this consignment. |
9 |
18/08/2023 |
MD/1694/08/2023 |
Technetium - 99m Drytec Generator - 10GBq |
26 |
CA/108424D0122/001, date:15/05/2023 |
USD 39,796.08 |
Medical Supplies Division |
Ezacibasi-Monrol Nuclear Products Co - Turkey. |
For MSD (For NMU - Peradeniya) (Not a donation) |
· No other registered sources for importing radioactive materials. |
Recommended only for this consignment. |
10 |
18/08/2023 |
MD/1695/08/2023 |
THS 125-I RIA Kits (100 Tubes Kit) , Free Thyroxin (FT4) 125-I RIA Kits (100 Tubes Kit) |
6000 + 6000 |
CA/108424D/0121/001, date: 15/05/2023 |
USD 11,780.59 |
Medical Supplies Division |
Beckman Coulter - Czeck Republic |
For MSD (For NMU - Peradeniya) (Not a donation) |
· No other registered sources for importing radioactive materials. |
Recommended only for this consignment. |
11 |
25/08/2023 |
MD/1701/08/2023 |
Coccidioides IDCF ID Antigen (CAT no: C30110) |
5 |
C000099439, date: 14/07/2023 |
USD 380.00 |
Microtech Biological (Pvt) Ltd |
Immuno-Mycologics - United Status |
For Medical Research Institute |
· Manufacturer is not registered. · No other registered sources. |
Recommended only for this consignment. Advised to register the product. |
12 |
25/08/2023 |
MD/1702/08/2023 |
Coccidioides IDTP ID Antigen |
5 |
C000099439, date: 14/07/2023 |
USD 380.00 |
Microtech Biological (Pvt) Ltd |
Immuno-Mycologics - United Status |
For Medical Research Institute |
· Manufacturer is not registered. |
Recommended only for this consignment. Advised to register the product. |
13 |
25/08/2023 |
MD/1703/08/2023 |
Cocci IDTP ID Positive Control |
5 |
C000099439, date: 14/07/2023 |
USD 394.40 |
Microtech Biological (Pvt) Ltd |
Immuno-Mycologics - United Status |
For Medical Research Institute |
· No other registered sources. |
Recommended only for this consignment. Advised to register the product. |
14 |
25/08/2023 |
MD/1704/08/2023 |
Histoplama ID Antigen |
7 |
C000099439, date: 14/07/2023 |
USD 532.00 |
Microtech Biological (Pvt) Ltd |
Immuno-Mycologics - United Status |
For Medical Research Institute |
· Manufacturer is not registered. |
Recommended only for this consignment. Advised to register the product. |
15 |
25/08/2023 |
MD/1705/08/2023 |
Histoplama ID Positive Control |
6 |
C000099439, date: 14/07/2023 |
USD 473.28 |
Microtech Biological (Pvt) Ltd |
Immuno-Mycologics - United Status |
For Medical Research Institute |
· No other registered sources. |
Recommended only for this consignment. Advised to register the product. |
16 |
25/08/2023 |
MD/1706/08/2023 |
Aspergillus ID Positive Control |
3 |
C000099439, date: 14/07/2023 |
USD 236.64 |
Microtech Biological (Pvt) Ltd |
Immuno-Mycologics - United Status |
For Medical Research Institute |
· Manufacturer is not registered. |
Recommended only for this consignment. Advised to register the product. |
17 |
25/08/2023 |
MD/1707/08/2023 |
Aspergillus ID Antigen |
3 |
C000099439, date: 14/07/2023 |
USD 228.00 |
Microtech Biological (Pvt) Ltd |
Immuno-Mycologics - United Status |
For Medical Research Institute |
· No other registered sources. |
Recommended only for this consignment. Advised to register the product. |
18 |
25/08/2023 |
MD/1708/08/2023 |
A. terreus ID Positive Control |
4 |
C000099439, date: 14/07/2023 |
USD 315.52 |
Microtech Biological (Pvt) Ltd |
Immuno-Mycologics - United Status |
For Medical Research Institute |
· Manufacturer is not registered. |
Recommended only for this consignment. Advised to register the product. |
19 |
25/08/2023 |
MD/1709/08/2023 |
Aspergillus terreus ID Antigen |
4 |
C000099439, date: 14/07/2023 |
USD 304.00 |
Microtech Biological (Pvt) Ltd |
Immuno-Mycologics - United Status |
For Medical Research Institute |
· No other registered sources. |
Recommended only for this consignment. Advised to register the product. |
20 |
25/08/2023 |
MD/1710/08/2023 |
Aspergillus niger ID Antigen |
1 |
C000099439, date: 14/07/2023 |
USD 76.00 |
Microtech Biological (Pvt) Ltd |
Immuno-Mycologics - United Status |
For Medical Research Institute |
· Manufacturer is not registered. |
Recommended only for this consignment. Advised to register the product. |
21 |
25/08/2023 |
MD/1711/08/2023 |
Aspergillus fumigatus ID Antigen |
4 |
C000099439, date: 14/07/2023 |
USD 304.00 |
Microtech Biological (Pvt) Ltd |
Immuno-Mycologics - United Status |
For Medical Research Institute |
· No other registered sources. |
Recommended only for this consignment. Advised to register the product. |
22 |
25/08/2023 |
MD/1712/08/2023 |
Aspergillus flavus ID Antigen |
2 |
C000099439, date: 14/07/2023 |
USD 152.00 |
Microtech Biological (Pvt) Ltd |
Immuno-Mycologics - United Status |
For Medical Research Institute |
· Manufacturer is not registered. |
Recommended only for this consignment. Advised to register the product. |
23 |
25/08/2023 |
MD/1713/08/2023 |
Candida ID Antigen |
4 |
C000099439, date: 14/07/2023 |
USD 304.00 |
Microtech Biological (Pvt) Ltd |
Immuno-Mycologics - United Status |
For Medical Research Institute |
· No other registered sources. |
Recommended only for this consignment. Advised to register the product. |
24 |
25/08/2023 |
MD/1714/08/2023 |
Candida ID Positive Control |
2 |
C000099439, date: 14/07/2023 |
USD 157.76 |
Microtech Biological (Pvt) Ltd |
Immuno-Mycologics - United Status |
For Medical Research Institute |
· Manufacturer is not registered. |
Recommended only for this consignment. Advised to register the product. |
25 |
25/08/2023 |
MD/1715/08/2023 |
Paracoccidiodes ID Antigen |
5 |
C000099439, date: 14/07/2023 |
USD 380.00 |
Microtech Biological (Pvt) Ltd |
Immuno-Mycologics - United Status |
For Medical Research Institute |
· Manufacturer is not registered. |
Recommended only for this consignment. Advised to register the product. |
26 |
25/08/2023 |
MD/1716/08/2023 |
Paracocci ID Postive Control |
5 |
C000099439, date: 14/07/2023 |
USD 394.40 |
Microtech Biological (Pvt) Ltd |
Immuno-Mycologics - United Status |
For Medical Research Institute |
· No other registered sources. |
Recommended only for this consignment. Advised to register the product. |
27 |
01/09/2023 |
MD/1725/09/2023 |
Nanopore Sequencing device, adapter and flow cells |
As per the invoice |
9007781, date: 28/07/2023 |
USD 7,826.99 |
Dr. A.D. De Silva, Biomedical Laborator 2, Faculty of Medicine, General Sir John Kotalawala Defence University |
Oxford Nanopore Technologies - United Kingdom |
For KDU |
Research Purpose |
Recommended only for this consignment. |
28 |
14/07/2023 |
MD/1660/07/2023 |
Dental Equipments |
As per the invoice |
40951, date: 01/06/2023 |
$2,730.70 |
Dr. Diffna Leon |
One Dental - Australia |
For Educational Purpose |
For Exam |
Recommended only for this consignment. |
Waiver of Registration Committee - Device 05/09/2023 - S.P.C |
|||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Recommendation |
01 |
15/08/2023 |
MD/1681/08/2023 |
Speaking Valve for tracheostomy tube with universal connection, Sterile |
100 NOS |
DHS/RS/RQ/251/896AK/21 , date: 21/06/2023 (SR No: 13200602) |
US $ 1,200.00 |
Dilmark Medicare (Pvt) Ltd |
Primed Halberstadt Medizintechnik GmbH - Germany |
SPC Tender (MSD Order) |
Manufacture registered with NMRA. No other valid registered sources available for speaking valve. |
Recommended only for this consignment Subject to submission of dossier for registration. |
02 |
15/08/2023 |
MD/1682/08/2023 |
SHAH GROMMENTS (Aural Grommet, Shah type or similar, size 1.0mm, sterile) |
1700 NOS (1000 Nos - 3 Months from L/C, 700 Nos - 6 months after 1st lot) |
DHS/RS/RQ/251/922AK/21, date: 20/07/2023 (SR No: 13200002) |
US $ 55,539.00 |
Dilmark Medicare (Pvt) Ltd |
Summit Medical LLC - USA |
SPC Tender (MSD Order) |
Manufacture is not registered with NMRA. No other valid registered sources available. |
Recommended only for this consignment Subject to submission of dossier for registration. |
03 |
15/08/2023 |
MD/1683/08/2023 |
Netcell Ear Wick 15mm (Ear Wick, Pope type or similar, sterile) |
6900 NOS (5000 Nos - 30 months from L/C, 1800 Nos - 6 months after 1st lot |
DHS/RS/RQ/251/922AK/21, date: 20/07/2023 (SR No: 13200501) |
US $ 61,479.00 |
Dilmark Medicare (Pvt) Ltd |
Network Medicals Products Limited - UK |
SPC Tender (MSD Order) |
Previously registered product with NMRA. (Ref: DVR/6438) Manufacturing site changed, but not applied for NMRA registration. No other registered sources. |
Recommended only for this consignment Subject to submission of dossier for registration. |
04 |
15/08/2023 |
MD/1684/08/2023 |
Netcell Nasal Pack 8cm (Nasal Tampon, straight, with draw string, 80mm lemgth, made of expandable surgical sponge, sterile |
1800 NOS |
DHS/RS/RQ/251/896AK/21 , date: 21/06/2023 (SR No: 13201600) |
US $ 25,200.00 |
Dilmark Medicare (Pvt) Ltd |
Network Medicals Products Limited - UK |
SPC Tender (MSD Order) |
· Previously registered product with NMRA. · (Ref: DVR-805-RR) |
Recommended only for this consignment Subject to submission of dossier for registration. |
05 |
08/06/2023 |
MD/1589/06/2023 |
Connector Double Swivel 360 degrees, with suction port |
700 |
DHS/ICL/X/RSS/055/199NB/2022, date:12/05/2023 |
US $ 84,487.04 |
Medigrow International SS (Pvt) Ltd |
Airways Surgical (Pvt) Ltd - India |
SPC ICL Tender |
· Manufacturer or Local Agent not registered. · ICL Product. |
Recommended only for this consignment. |
Suction Tube, Peadiatric, baby yankeur type similar |
10000 |
||||||||||
Closed system suction catheter for ventikated patients, single use. |
800 |
||||||||||
Closed system suction catheter for ventikated patients, double use. |
6000 |
||||||||||
06 |
01/09/2023 |
MD/1723/09/2023 |
Epidural & Plexus Anesthesia System |
6250 NOS |
LP/DHS/RS/RQ/228/920AK/21, date: 20/07/2023 |
LKR 24,500,000.00 |
Sunshine Healthcare Lanka (Pvt) ltd |
Smith Medical ASD Inc - USA. |
SPC Tender |
|
Recommended only for this consignment. Advised to register the product. |
07 |
01/09/2023 |
MD/1724/09/2023 |
Ring pressaries/Polythene/size 68mm external diameter/semi rigid/smooth finish/clinically clean |
As per the invoice |
DSH/S/WW/05/23, date: 07/02/2023 |
LKR 91,837,149.00 |
Sunshine Healthcare Lanka (Pvt) ltd |
Cooper Surgical Inc - USA |
SPC Tender |
|
Recommended only for this consignment Subject to submission of dossier for registration. |
Waiver of Registration Committee - Device 12/08/2023 |
|||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Recommendation |
01 |
15/06/2023 |
MD/1612/06/2023 |
Used Toyota Ambulance (Nissan Elgrand Ambulance) |
1 |
54231-0335, date: 08/5/2023 |
JPY 800,000 |
Olivia Hospital (Pvt) Ltd |
Nissan Co. Japan - Japan |
For Olivia Hospital |
· Donation. |
Recommended only for this consignment. Related medical devices should be evaluated by college of Aneasthesiologists. |
02 |
23/06/2023 |
MD/1585/06/2023 |
VIVACE Electrosurgical Device |
1 |
SHP230601SSA, date: 14/06/2023 |
USD 16,500.00 |
Silvacos (Pvt) Ltd |
Shenb Co.ltd - Korea south |
For a private skin clinic. |
· Manufacturer or Local Agent not registered. Not applied for product registration. |
Not recommended and advised to register the product. |
03 |
15/06/2023 |
MD/1590/06/2023 |
Blood Collection Needle |
50,000 Pcs |
61230073, date: 17/05/2023 |
EUR 2,000,00 |
Ceylon Meditech Industries (Pvt) Ltd |
Chirana T. Injecta - Slovak Republic |
|
· Local agent has applied for the product registration (D-4616) and Pending heamotology evaluation. · Registered Sources Available (Needle for Vacuum blood collection tube) |
Not recommended. Advised to Expedite the registration. |
04 |
13/07/2023 |
MD/1641/07/2023 |
Endo GIA , Premium Plus CEEA |
25 |
03-2-2023-COVIDIEN, date: 26/06/2023 |
USD 12,209.00 |
A. Baur & Co. (Pvt) Ltd |
Covidien LLC - USA |
For Kings Hospital - Colombo |
· Local Agent has applied for product registration renewal. (D/4360 and D/4290) |
Not recommended. Advised to Expedite the registration. |
05 |
21/07/2023 |
MD/1661/07/2023 |
HomoSphere Advanced Monitoring Platform and List Components / Accessories |
N/A |
N/A |
N/A |
Meditechnology Holdings (Pvt) Ltd |
Benchmark Electronics Inc - USA |
For University Hospital - KDU and LRH Hospital (For Workshop) |
· Manufacturer is registered. · Device for a Workshop to be done by the distributor and it will be returned back with the distributer once the workshop is over. |
Recommended only for this consignment. To be re-exported after the workshop. |
06 |
14/07/2023 |
MD/1659/07/2023 |
Spectra Optia Exchange Set / Spectra Optia IDL Set |
936EA + 84EA |
950093846, date: 10/07/2023 |
$132,600.00 |
Hemas Surgicals & Diagnostics (Pvt) Ltd |
Terumo BCT Inc - USA |
For National Blood Transfusion Services |
· Previously WOR given on 09/05/2023. (WOR/DVR/195/2023) · The same NBTS Letters are attached with the Previous and New WOR requests. · SIL is approved · Product files not submitted to NMRA by Local Agent. |
Recommended only for this consignment. (WOR for this consignment due to low stock level) |
07 |
11/08/2023 |
MD/1670/08/2023 |
Human Kidney injury molecule 1, Kim-1-ELISA Kit, Human neutrophil gelatinase associated lipocalin, NGAL ELISA Kit |
20 + 20 |
2023-0615-22-06, date: 19/06/2023 |
USD 12,600.00 |
Prof: P/Mangala C.S. De Silva, Department of Zoology, Faculty of Science, University of Ruhuna |
Wuhan Humaei Biotech Co.Ltd - China |
For Research Purpose |
· Donation from Duke University - USA. |
Recommended only for this consignment. |
08 |
14/03/2023 |
MD/1453/03/2023 |
Life Signals Multiparameter Remote Monitoring System and Spare Parts Accessories (Brand:Biosensor , Model LX 1550) |
50 |
01032023/HEMAS, date: 01/03/2023 |
$500.00 |
Hemas Surgical & Diagnostics (Pvt) ltd |
Life Signals Inc - USA |
For Testing and Examination Purposes. |
· Submitted to WOR Committee held on 30/05/2023 and Decision was Pending decision. Instructed to submit reports for product with prior WOR approval. · Again Submitted to WOR Committee held on 15/06/2023 and Decision was Pending decision. No appeal request submitted. |
Previously Discussed and document reviewing. |
Waiver of Registration Committee - Device 12/08/2023 - S.P.C |
|||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Recommendation |
01 |
11/07/2023 |
MD/1639/07/2023 |
Soft Cloth Liner Tape |
21,489 |
LP/DHS/RS/EP/67/548KC/2022, date: 27/06/2023 |
LKR 10,467,077.01 |
Shaka Holdings (Pvt) Ltd |
Jinhua jingdi Medical Supplies Co.Ltd - China |
SPC Tender |
· Registered Manufacture with Rokem Pharmaceuticals. No active registrations available. · Local Agent is not registered with NMRA. · Other valid registered sources available. · Previously WOR given by CEO Minute. (Dated on 09/03/2023, (WOR/DVR/134/2023)) |
Not recommended and advised to register the product. (Decision as per previous consignment) |
02 |
13/07/2023 |
MD/1644/07/2023 |
Root Canal Sealer , Resin Based, for permanant filling of root canal |
4200 |
LP/DHS/S/WW/237/900KP/21, date: 29/06/2023 |
Ogaki & Company |
Shiva Products - India |
SPC Tender |
· Manufacturer registered with LW Medicals. All the other products were Agency Transferred to Ogaki & Company. · Other registered sources are available. · Not applied for product registration. |
Not recommended and advised to register the product. |
|
03 |
11/07/2023 |
MD/1638/07/2023 |
Hearing aid and standard accessories |
17500 |
LP/DHS/M/S/WW/12/874MT/21, date: 02/05/2023 |
LKR 790,125,000.00 |
D.S. Jayasinghe Optician (Pvt) Ltd |
Sivantos GmbH - Germany |
SPC Tender |
· Previously registered product (D/183) and site has been changed. · FSC is still being processed in the country of origin. |
Recommended only for this consignment. Advised to register the new site. |
04 |
21/07/2023 |
MD/1662/07/2023 |
Rib Shear (Reusable Instruments) |
02 Nos |
DHS/SUS/WW/190/581DR/2021, date: 26/08/2022 (SR No: 21802701) |
EUR 1545.60 |
B. Braun Lanka (Pvt) Ltd |
Aesculap AG - Germany |
SPC Tender |
· Manufacturer and Local Agent registered. · No other registered sources available. |
Recommended only for this consignment. |
05 |
13/07/2023 |
MD/1643/07/2023 |
Soft Cloth Liner Tape (Non-Women Fixing Tape) |
70,000 |
LP/DHS/RS/EP/2/28KC/2023, date: 26/06/2023 , LP/DHS/RS/EP/3/30KC/2023, date: 26/06/2023 |
LKR 7,623,000.00 + LKR 18,364,500.00 |
Medica Pharmaceuticals (Pvt) Ltd |
Zheijiang Kekang Medical Technology Co.Ltd - China |
SPC Tender |
· Two other valid registered sources are available. · Manufacturer is not registered. · Local Agent is not registered. |
Not recommended and advised to register the product. |
06 |
14/03/2023 |
MD/1454/03/2023 |
C Reactive Protein Latex Agglutination 100 Tests/Kit |
1000 |
DHS/ICL/X/RL/031/25SM/22, date: 28/10/2022 |
US$ 7,500.00 |
Elshaddai Enterprises (Pvt) ltd |
Genuine Biosystem (Pvt) ltd - India |
SPC ICL |
· Manufacture is registered. But No active registrations available. · Local Agent is registered. · Registered sources available. |
Not recommended by college of chemical pathologists. |
07 |
10/03/2023 |
MD/1450/03/2023 |
Orthodontic Wires and Brackets |
As per the indent |
DHS/ICL/X/RSS/060/163RD/2022, date: 19/01/2023 |
As per the indent |
Demed (Pvt) ltd |
Modern Orthodontics - India |
SPC ICL |
· Manufacturer is not registered. · Local Agent is registered. |
Recommended only for this consignment. Advised to submit the dossier for registration. |
08 |
10/03/2023 |
MD/1451/03/2023 |
Orthodontic Wires |
As per the indent |
DHS/ICL/RSS/064/165RD/22, date: 25/01/2023 |
As per the indent |
Demed (Pvt) ltd |
Modern Orthodontics - India |
SPC ICL |
· Manufacturer is not registered. · Local Agent is registered. |
Recommended only for this consignment. Advised to submit the dossier for registration. |
Waiver of Registration Committee - Device 15/07/2023 |
|||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Recommendation |
01 |
22/06/2023 |
MD/1613/06/2023 |
HLA Reagents and consumables |
As per the invoice |
8222118, date: 12/06/2023 |
USD 5,338.18 |
Emar Pharma (Pvt) Ltd |
One Lambda Inc - USA |
For National Blood Transfusion Service |
Previously given WOR. (WOR/DVR/316 , WOR/DVR/69) Manufacturer is registered with NMRA. No other registered sources. |
Recommended only for this consignment. Advised to initiate product registration. |
02 |
22/06/2023 |
MD/1619/06/2023 |
DNA Whole Blood Kit (Brand: MagCore Genomic) |
46 |
EP/RBC/02-2023, date: 12/06/2023 |
$3,766.00 |
Emar Pharma (Pvt) Ltd |
RBC Bioscience Corp. - Taiwan |
For National Blood Transfusion Service |
Manufacturer is not registered with NMRA. |
Recommended only for this consignment. Suggested to initiate product registration. |
03 |
31/05/2023 |
MD/1578/06/2023 |
OPPO non-active orthopedic appliance |
As per the invoice |
OP01-202303009, date: 16/03/2023 |
USD 74,655.79 |
Hemas Surgical & Diagnostics (Pvt) Ltd |
OPPO Medical Corporation - Taiwan |
For Manufacturing Site Change |
Previously given WOR. (15/12/2022, WOR/DVR/483/2022) Site is registered with NMRA for this local agent. |
Not recommended. Advised to expedite the registration. |
04 |
31/05/2023 |
MD/1579/06/2023 |
OPPO non-active orthopedic appliance |
As per the invoice |
OP01-202303008, date: 16/03/2023 |
USD 262,370.53 |
Hemas Surgical & Diagnostics (Pvt) Ltd |
OPPO Medical Corporation - Taiwan |
For Manufacturing Site Change |
Previously given WOR. (15/12/2022, WOR/DVR/484/2022) Site is registered with NMRA for this local agent. |
Not recommended. Advised to expedite the registration. |
05 |
30/06/2023 |
MD/1628/07/2023 |
Reagents for Hematology Analyzer |
As per the invoice |
10040645, date: 07/06/2023 , 10040646, date: 14/06/2023 |
USD 34,885.00 + USD 2,470.00 |
Hemas Surgicals & Diagnostics (Pvt) Ltd |
Nihon Kohden - Japan |
For Sri Lanka Air Force and Department of Health Services-Northwesstern Province. |
Manufacturing site is registered with NMRA. No other registered sources for Nihon Kohden hematology reagents. |
Recommended only for this consignment. |
06 |
22/06/2023 |
MD/1616/06/2023 |
Mizuho Vascular Doppler System |
9 |
PI23-066, date: 05/06/2023 |
USD 14,368.00 |
Medapp (Pvt) Ltd |
Vascular Technology Inc - USA |
For Vascular Neuro Surgeries. (Dr. Sunil Perera, Consultant Neurosurgeon, Central Hospital (Pvt) Ltd) |
Manufacturer is registered under NMRA with another local agent. One registered source available. |
Not recommended and advised to register the product. |
07 |
22/06/2023 |
MD/1615/06/2023 |
Video Endoscopy System with Accessories and Spare Parts |
As per the invoice |
PMSSPI20872/89, 30/5/2023 |
USD 23,038.94 |
Biomed (Pvt) Ltd |
Hoya Corporation - Japan |
For Several government hospital |
Addition of items to the existing accessory list can be done. |
Advised to follow the variation process. |
08 |
22/06/2023 |
MD/1617/06/2023 |
Transport Cooler (Brand: Haier, Model: BCD115) |
1 |
HRP-003-BIOMEDICA-2023, date: 16/06/2023 |
USD 395.00 |
Biomedica (Pvt) Ltd |
Haier Biomedical Co.ltd - China |
|
Manufacturer is currently not registered at NMRA. |
Not recommended and advised to register the product. |
09 |
13/06/2023 |
MD/1589/06/2023 |
Face Mask ASTMD 5034/ASTMD 2261 |
200 |
IE6604000016, date: 25/04/2023 |
USD 200.00 |
Ansell Lanka (Pvt) Ltd |
Prudential Ampri (Thailand) Co.ltd - Thailand |
For ISO 4 standard clean room operational works. |
Manufacturer is not registered with NMRA. |
Advised to apply for product categorization. |
10 |
07/07/2023 |
MD/1640/07/2023 |
Microtome Blade |
2 |
9999052424 date: 21/06/2023 |
EUR 128.02 |
Analytical Instruments |
Richard-Allan Scientific LLc - USA |
For Army Medical Procurement Services |
Manufacturer is registered. |
Not recommended and advised to register the product. |
11 |
30/06/2023 |
MD/1627/07/2023 |
iTero Element CPO Flex intra oral scanner |
01 |
Invoice date: 05/06/2023 |
INR 999,999.00 |
Dr. K. Paranthamalingam |
Zheijiang Kekang Medical Technology Co.Ltd - China |
For private orthodontic clinic. |
|
Not recommended and advised to register the product. |
12 |
07/07/2023 |
MD/1645/07/2023 |
Portable Stretcher |
500 |
SHS-23107, date: 26/06/2023 |
US $ 15,000.00 |
Korean Lanka Holding |
Suzhou Highsee Medical Co.Ltd - China |
For Sri Lanka Railways |
|
Recommended only for this consignment. |
13 |
07/07/2023 |
MD/1648/07/2023 |
Emergency Bandages and Sam Splint |
As per the invoice |
30569, date: 11/10/2023, 9000043731, date: 2510/2022 |
985.14 |
The HALO Trust |
Ferton Pharmaceuticals Ltd – London SP Services (UK) Ltd |
For National Mine Action Centre (NMAC) |
|
Recommended only for this consignment. |
14 |
11/07/2023 |
MD/1649/07/2023 |
Cysto-nephro Fiberscope |
2 |
5092640, date: 06/07/2023 |
SDG 19,630 |
Technomedics International |
Olympus Medical System Cor- Japan |
For University of Sri Jayawardenepura |
Previously registered product with NMRA and expired. |
Recommended only for this consignment. Advised to expedite registration. |
15 |
11/07/2023 |
MD/1650/07/2023 |
Pharmacy Refrigerator |
1 |
HRP-004-BIOMEDICA-2023, date: 06/07/2023 |
USD 780.00 |
Biomedica (Pvt) Ltd |
Haier Biomedical Co.Ltd - China |
For District General Hospital - Galle |
One registered source available. |
Not recommended and advised to register the product. |
16 |
23/05/2023 |
MD/1560/05/2023 |
Wallace Catheters & Oocyte Recovery Set |
420 |
OIPL/23-24/PI/AB/001, date: 27/04/2023 |
$29,652.00 |
A. Baur & Co. (Pvt) ltd |
Cooper Surgical Inc - USA |
For Several Private Hospitals in Sri Lanka |
Submitted to WOR Committee held on 30/05/2023 and Decision was Not recommended and advised to register the product. (Manufacture registered with another local agent.) |
Not recommended. Manufacturer registered with another local agent. Advised to complete the market authorization transfer process. |
17 |
25/05/2023 |
MD/1572/05/2023 |
Semi-Automated Coagulometer with Accessories Consumables, Controls & Re-agents (C-Series) |
1 + 1 |
3420/0012216 |
$1,812.72 |
Analytical Instruments (Pvt) Ltd |
Helena Biosciences Europe - UK |
For Premium International (Pvt) Ltd (For New Maternity Hospital - Galle) |
Submitted to WOR Committee held on 20/06/2023 and Decision was Pending Decision. Advised to apply for renewal of registration.
Previously registered product with NMRA. Existing registered is expired. Registered sources available for different brands. |
Will give consignment clearance when the product file is submitted. Advised to expedite the registration. |
18 |
14/03/2023 |
MD/1453/03/2023 |
Life Signals Multiparameter Remote Monitoring System and Spare Parts Accessories (Brand:Biosensor , Model LX 1550) |
50 |
01032023/HEMAS, date: 01/03/2023 |
$500.00 |
Hemas Surgical & Diagnostics (Pvt) ltd |
Life Signals Inc - USA |
For Testing and Examination Purposes. |
Submitted to WOR Committee held on 30/05/2023 and Decision was Pending decision. Instructed to submit reports for product with prior WOR approval. |
Pending decision. No appeal request submitted. |
19 |
01/06/2023 |
MD/1580/06/2023 |
Investment Materials, Expansion Liquid, Plaster Paris Hard, Casting Ring Liners, Duplicating Gel, Silicone, Waxes-Paraffin, Light Cure Acrylic for Customs Impression Crown, Bridge Acrylic. |
As per the invoice |
230676, date: 05/04/2023 |
EUR 1,752.93 |
Geston Lanka (Pvt) Ltd |
Mega dental GmbH - Germany |
For external use in dental laboratories. |
Submitted to WOR Committee held on 20/06/2023 and Decision was Pending Decision. Advised to submit a product catalogue for the NMRA registered products. Previously registered few products from a registered manufacturer. (Expired) |
Advised to apply for Product Categorization. |
Waiver of Registration Committee - Device 15/07/2023 - S.P.C |
|||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Recommendation |
1 |
09/01/2023 |
Bacterial and Viral Filter Paediatric , Incentive Spirometer for Paediatric, disposible |
18,000 + 6,000 |
DHS/ICL/X/RS/053/340AK/22, date: 17/10/2022 |
US $ 53,160.00 |
Medigrow International SS (Pvt) ltd |
J.K Medical Systems (Pvt) ltd - India |
SPC ICL Procurement |
Manufacturer not registered with NMRA. |
Recommended only for this consignment of Spirometers. Bacterial and Viral Filter Paediatric should be sent to college of Microbiologists. |
|
2 |
09/01/2023 |
Incentive Spirometer fo Adult, disposible |
58,000 |
DHS/ICL/X/RS/053/362AK/22, date: 25/10/2022 |
US $ 181,540.00 |
Medigrow International SS (Pvt) ltd |
J.K Medical Systems (Pvt) ltd - India |
SPC ICL Procurement |
Manufacturer not registered with NMRA. |
Recommended only for this consignment. |
Waiver of Registration Committee - Device 20/06/2023 |
|||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Recommendation |
1 |
25/04/2023 |
MD/1516/05/2023 |
CAP Samples |
6 |
448503-1, date: 31/10/2023 |
$3,049.00 |
Stemz Healthcare Lanka |
College of American Pathologists - USA |
For CAP Programme |
No registered sources at present. |
Recommended only for this consignment. |
2 |
25/05/2023 |
MD/1572/05/2023 |
Semi-Automated Coagulometer with Accessories Consumables, Controls & Re-agents (C-Series) |
1 + 1 |
3420/0012216 |
$1,812.72 |
Analytical Instruments (Pvt) Ltd |
Helena Biosciences Europe - UK |
For Premium International (Pvt) Ltd (For New Maternity Hospital - Galle) |
Previously registered product with NMRA. Existing registered is expired. Registered sources available for different brands. |
Pending Decision. Advised to apply for renewal of registration. |
3 |
23/05/2023 |
MD/1564/05/2023 |
Vigor Peek Disc Spacer (O), Polyaxial Screw, Smooth Rod, Hex Set Screw |
817 |
ASD6-2212000007, ASD6-2304000009, date: 24/04/2023 |
28,490.00 |
Spine Care (pvt) ltd |
A-Spine Asia Co.ltd - Taiwan |
Site Location Change |
Product is registered. Due to the manufacturing site change, the new location should be registered. |
Not recommended and advised to register the product. |
4 |
29/05/2023 |
MD/1577/05/2023 |
Plaster of Paris Bandage |
1,008 |
JX230318, date: 18/03/2023 |
$644.11 |
Nirutha Packaging (Pvt) Ltd |
Anji Hongde Medical Product Co.Ltd - China |
For release the consignment |
Manufacturer is not registered with NMRA. Other registered sources are available. |
Not recommended and advised to register the product. |
5 |
01/06/2023 |
MD/1580/06/2023 |
Investment Materials, Expansion Liquid, Plaster Paris Hard, Casting Ring Liners, Duplicating Gel, Silicone, Waxes-Paraffin, Light Cure Acrylic for Customs Impression Crown, Bridge Acrylic. |
As per the invoice |
230676, date: 05/04/2023 |
EUR 1,752.93 |
Geston Lanka (Pvt) Ltd |
Mega dental GmbH - Germany |
For external use in dental laboratories. |
Previously registered few products from a registered manufacturer. (Expired) |
Pending Decision. Advised to submit a product catalogue for the NMEA registered products. |
6 |
15/06/2023 |
MD/1591/06/2023 |
FDG F-18 (Flurodeoxyglucose 18F) |
60 LOT (6000 Nos) |
MARK/PI/1/23-24, date: 19/06/2023 |
USD 108,000 |
Markss HLC (PVT) Ltd |
Shreeji Imaging & Diagnostic Centure Pvt Ltd - India |
For Apeksha Hospital - Maharagama |
Not registered sources for FDG F - 18. Manufacturer is not registered. |
Not recommended and advised to register the product. (Already registered product of Siemns with Dimo (Pvt) Ltd. FDG F-18 should come under Atomic Energy Authority approval.) |
7 |
16/06/2023 |
MD/1592/06/2023 |
Medtronic Spine (Brand: Medtronic) |
As per the invoice |
MKT_052023_SG-LK, date: 05/06/2023 |
USD 231,439.07 |
A. Baur & Co. (Pvt) Ltd |
Medronic Inc - USA |
For The Sri Lanka Orthopedic AssociationWorkshop Programme (Re-export basis) |
Manufacturer is registered. |
Recommended only for this consignment. |
Waiver of Registration Committee - Device 20/06/2023 - S.P.C |
|||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Recommendation |
1 |
28/04/2023 |
MD/1522/05/2023 |
Drill Wire Kishner type or similar, both ends trocar pointed |
As per the indent |
DHS/S/WW/40/290VW/22, date: 07/10/2022 |
US $ 6,293.00 |
Excel Agency |
M/S Siora Surgical (Pvt) ltd - India |
SPC Tender (Process Under the Indian Credit Line Facility) |
Manufacturer & the product is previously registered. (Expired) Other registered sources are available. |
Recommended only for this consignment. |
2 |
21/04/2023 |
MD/1510/04/2023 |
Oxygen Masks / Hudson Mask with tubing for adult |
150,000 NOS |
LP/DHS/RS/EP/61/486AK/22, date: 06/04/2023 |
LKR 41,250,000.00 |
Sethmedi International (Pvt) ltd |
Guangdong Ecan Medical Co.ltd - China |
SPC Tender |
Submitted to WOR Committee held on 30/05/2023 and Decision was Not recommended and advised to register the product. Advised to submit the samples for end-user evaluation. (College of Anesthesiologists.) |
Not recommended and advised to register the product. Advised to purchase from registered sources available for the product. |
Waiver of Registration Committee - Medical Device (January 2023 to May 2023) |
|||||||||||||
06/01/2023 |
|||||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Approval |
||
1 |
21/11/2022 |
MD/1224/11/2022 |
Elastic Adhesive Bandage |
30000 Pcs |
IMC/2022-23/554, date: 15/11/2022 |
USD 25,700.00 |
Sisili Projects Consortium (Pvt) ltd |
Imperial Medicare (Pvt) ltd - India |
For State Pharmaceuticals Corporation |
Manufacturer is registered. Registered Source available. Sample license applied on November 2022. |
Not recommended. Expedite the registration. |
||
2 |
21/11/2022 |
MD/1225/11/2022 |
Folding Stretchers |
130 |
SHS-22187, date: 19/10/2022 |
US $ 3,900.00 |
Cooper International |
Suzhou Highsee Medical Co.ltd - China |
For Sri Lanka Railways |
Manufacture is not registered. Registered source available. Purchasing from unregistered source. |
Not recommended and advised to re-export. |
||
3 |
21/11/2022 |
MD/1226/11/2022 |
Autoclave Machine with Standard Accessories and Spare Parts (Eschmann - Autoclave Machine) (Brand: Eschmann) |
40 |
18096, date: 07/11/2022 |
E 1,052.40 |
Mediquipment Limited |
Wschmann Technologies Ltd - UK |
For Asiri Surgical Hospital |
Manufacturer is registered. |
Recommended only for this consignment. |
||
4 |
28/11/2022 |
MD/1233/11/2022 |
Automatic Blood Component Extractor and Standard Accessories (Brand: Delcon, Model: Gioto-Monza) |
1 |
N/A |
LKR 13,366.093.00 |
A.J. Medichem International (Pvt) ltd |
Delcon SRL - Italy |
For General Sir John Kotelawala Defence University Hospital |
Manufacturer is registered. Registered sources available. (Ceyoka and Hemas) |
Not recommended. Expedite the registration. |
||
5 |
23/11/2022 |
MD/1235/12/2022 |
2% Hydroxypropyl Methyl Cellulose Ophthalmic Solution USP/BP (Brand: Optagel) |
132000 |
14/POP/ABCPSL/07/2022-23, date: 10/11/2022 |
USD 18,000.00 |
ABC Pharma Services (Pvt) ltd |
Popular Phrmaceuticals (Pvt) ltd - Bangaladesh |
|
Manufacturer is registered. (Registered Sources available.) |
Recommended only for this consignment. |
||
6 |
30/11/2022 |
MD/1236/12/2022 |
Sterilizer - Sterilizer System and Spare Parts, Standard Accessories (Getinge HS 66 Hospital Sterilizer) (Brand: Getinge, Model: HS Series) |
1 |
8085412708, date: 23/11/2022 |
USD 2432.86 |
Mediquipment Limited |
Getinge AB - Sweden |
For Lanka Hospital |
|
Recommended only for this consignment. |
||
7 |
30/11/2022 |
MD/1237/12/2022 |
Ion Plus Efragment Kit, Seqstudio Cathode Buffer Container, Seqstudio Cartridge V2, Ion Ampliseq Library Kit Plus, Genescan 600 LIZ dye Size Standard v2.0, Ion 540 Kit-OT2, Ion SingleSeq 96 Kit LUN, AmpFLSTR Identifiler Plus PCR Amplification Kit |
As per the invoice |
73942051 SO, date: 22/11/2022 |
USD 20,722.00 |
Genelabs Medical (Pvt) ltd |
Life Technologies Holdings (Pte) Ltd - Singapore |
For Research Purpose |
|
Recommended only for this consignment. |
||
8 |
16/12/2022 |
MD/1267/12/2022 |
HLA Reagents |
87 + 42 |
7883657, date: 12/02/2022, 7883707, date: 12/02/2022 |
USD 116,946.92 + USD 12,578.70 |
Emar Pharma (Pvt) ltd |
One Lambda Inc - USA |
For Nationaal Blood Transfusion Service |
Already issued by CEO Minute. |
CEO Decision. |
||
9 |
13/12/2022 |
MD/1268/12/2022 |
Glucose Meter, Test strips, Blood Lancets |
600 + 6000+ 12000 |
SL-90197-20221130, date: 30/11/2022 |
$ 29.920.00 |
Medica Pharmaceuticals (Pvt) ltd |
Visgeneer Inc - Taiwan |
Out of Stock situation in the health sector |
|
Not recommended and advised to register the product. |
||
10 |
13/12/2022 |
MD/1269/12/2022 |
Amies Agar Gel + Charcoal (Single), Puritan HydraFlock 6" Sterile Mini-tip Flock Swab w/Polystyrene Handle, Parafild, SSIbio 2ml standing screw tubes, Axgen 1.5 ml microcentrifuge tubes, Disposable Wireloops |
500 + 500 + 2 rolls + 2000 + 2000 + 2000 |
Date : 14/11/2022 |
HK $ 9,939.62 |
Veranja Liyanapathirna, Department of Microbiology, Faculty of Medicine, University of Peradeniya |
Department of Microbiology - Hong Kong |
For Research Purpose |
|
Subject to submission of Ethic Review Committee Approval. |
||
11 |
15/12/2022 |
MD/1270/12/2022 |
Laparoscopy System with St Accessories Spare Parts |
As per the invoice |
00034676, date: 06/12/2022 |
SGD 116,061.54 |
Technomedics International (Pvt) ltd |
Olympus Medical Systems Corp - Japan |
|
Recommended only for this consignment and expedite the registration. |
|||
12 |
19/12/2022 |
MD/1277/12/2022 |
Automated External Defibrillator and Spare Parts |
6 |
10034184, date: 15/12/2022 |
USD 4,165.98 |
Hemas Surgical & Diagnostics (Pvt) ltd |
Nihon Kohden - Japan |
For Colombo International Container Terminals Limited. |
|
Not recommended. Expedite the registration. |
||
13 |
21/12/2022 |
MD/1278/12/2022 |
Interacoustics Titan-DPOAE440 |
1 |
PO NO: PO58539, date: 23/11/2022 |
Rs. 3,080,000.00 |
J.M. Wickramarachchi & Company (Pvt) ltd |
Interacoustics A/S - Denmark |
For Ninewells Hospital (Pvt) ltd |
|
Recommended only for this consignment. Expedite product registration process. |
||
14 |
21/12/2022 |
MD/1281/12/2022 |
Sterilizer - Sterilizer System and Spare Parts, Standard Accessories (Getinge HS 66 Hospital Sterilizer) (Brand: Getinge, Model: HS Series) |
As Per the invoice |
8085412847, date: 15/12/2022 |
USD 7,235.24 |
Mediquipment Limited |
Getinge AB - Sweden |
For Wathupitiwala Base Hospital |
|
Recommended only for this consignment. |
||
15 |
15/12/2022 |
MD/I283/12/2022 |
College of American Pathologist (CAP) Proficiency Testing Program |
As Per the invoice |
432115 (CAP Number: 902147901) , date: 05/12/2022 |
$73,745.00 |
Lanka Hospital Diagnostics (Pvt) ltd |
College of American Pathologist - United States of America |
For CAP Programme |
|
Recommended only for this consignment. |
||
16 |
27/12/2022 |
MD/1291/01/2023 |
Syringe, IV Set with Air vent, IV Cannula (Brand: Hi-Teck) |
1,085,500 |
PI/HM/2022-23/078, date: 21/11/2022 |
$37,539.50 |
Medica Pharmaceuticals (Pvt) ltd |
Hi-Teck Medics (Pvt) ltd - India |
For Government Hospitals. |
|
Not recommended and advised to register the product. |
||
17 |
27/12/2022 |
MD/1292/01/2023 |
Cysto-nephro Fiberscope (Brand: Olympus, Model: CYF-5A) |
1 |
RSI-FY2023-189R, date: 19/12/2022 |
SGD 8,077.12 |
Technomedics International (Pvt) ltd |
Olympus Medical Systems Corp - Japan |
For Clear the Shipment |
|
Not recommended. Expedite the registration. |
||
18 |
29/12/2022 |
MD/1294/01/2023 |
Medical Items |
As per the invoice |
00034780, date: 14/12/2022 |
SGD 301,959.00 |
Technomedics International (Pvt) ltd |
Olympus Medical Systems Corp - Japan |
For Clear the Shipment |
|
Not recommended and advised to register the product. |
||
19 |
23/12/2022 |
MD/1301/01/2023 |
Medical Items |
As per the invoice |
00034783, date: 14/12/2022 |
SGD 296,054.88 |
Technomedics International (Pvt) ltd |
Olympus Medical Systems Corp - Japan |
For Clear the Shipment |
|
Not recommended and advised to register the product. |
||
20 |
28/12/2022 |
MD/1302/01/2023 |
Colostomy Bags |
10000 |
221223, date: 23/12/2022 |
$8,420.00 |
Medica Pharmaceuticals (Pvt) ltd |
Whuhan Sitaili Medical Apparatus Development Co.ltd - china |
Above Health System Enhancement project |
|
Not recommended and advised to register the product. |
||
21 |
07/09/2022 |
MD/1062/09/2022 |
Dental Extraction Elevators |
1 |
S20220608, date:08/09/2022 (DE 532) |
USD$ 55.90 |
Dr. Neil Hemantha Karandeniya |
SCS Medical Instrument Ltd - China |
For Surgery. |
Not registered Manufacturer. |
Submitted to WOR Committee held on 08/10/2022 and Decision was Pending Decision. Advised to submit letters from Local Suppliers indicating that this equipment cannot be supplied. |
Not recommended. Advised to purchase from local supplier. |
|
22 |
07/09/2022 |
MD/1063/09/2022 |
Autoclave Sterilizer |
1 |
S20220608, date:08/09/2022 |
USD$ 480.00 |
Dr. Neil Hemantha Karandeniya |
SCS Medical Instrument Ltd - China |
For Surgery. |
||||
23 |
07/09/2022 |
MD/1064/09/2022 |
Complete Dental Chair and Unit + Air Compressure |
2 |
S20220608, date:08/09/2022 |
USD$ 4,730.00 |
Dr. Neil Hemantha Karandeniya |
SCS Medical Instrument Ltd - China |
For Surgery. |
||||
24 |
07/09/2022 |
MD/1065/09/2022 |
Physio Dispensor |
1 |
S20220608, date:08/09/2022 (C-SAILOR) |
USD $ 1,700.00 |
Dr. Neil Hemantha Karandeniya |
SCS Medical Instrument Ltd - China |
|||||
25 |
07/09/2022 |
MD/1066/09/2022 |
Dental Light Luring Metchine |
1 |
S20220608, date:08/09/2022 (LED-B) |
USD$ 53.00 |
Dr. Neil Hemantha Karandeniya |
SCS Medical Instrument Ltd - China |
For Surgery. |
||||
26 |
07/09/2022 |
MD/1067/09/2022 |
SCS Extraction Forceps |
1 |
S20220608, date:08/09/2022 (DE-255) |
USD $ 50.00 |
Dr. Neil Hemantha Karandeniya |
SCS Medical Instrument Ltd - China |
For Surgery. |
||||
27 |
07/09/2022 |
MD/1068/09/2022 |
Dental Extraction Froceps |
1 |
S20220608, date:08/09/2022 (DE-256) |
USD $ 80.00 |
Dr. Neil Hemantha Karandeniya |
SCS Medical Instrument Ltd - China |
For Surgery. |
||||
28 |
07/09/2022 |
MD/1069/09/2022 |
Dental Extraction Froceps |
1 |
S20220608, date:08/09/2022 (DE-254) |
USD $ 75.00 |
Dr. Neil Hemantha Karandeniya |
SCS Medical Instrument Ltd - China |
For Surgery. |
||||
29 |
07/09/2022 |
MD/1070/09/2022 |
Dental Extraction Froceps |
1 |
S20220608, date:08/09/2022 (DE-253 |
USD $ 97.50 |
Dr. Neil Hemantha Karandeniya |
SCS Medical Instrument Ltd - China |
For Surgery. |
||||
30 |
07/09/2022 |
MD/1071/09/2022 |
PCS CRP rapid test kit, PCS FTN test Kits, PCS CTN test kits, PCS CRP test detection buffer |
8+2+3+8 |
N/A |
N/A |
A.A. Jeyapragasam |
M/s. Guangzhou Wondfo Biotech Co.ltd - China |
For Abishaa Hospital (Pvt) ltd - Vavuniya |
Manufacturer is registered under NMRA with, Lifeserv – HCG Strips. - PC Pharma - Syphilis test. - Sri Chin Holdings – HCG Strip. |
Submitted to WOR Committee held on 08/10/2022 and Decision was Not recommended and advised to register the product. |
Not Recommended. Expedite the registration. |
|
06/01/2023 - S.P.C |
|||||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Approval |
||
1 |
23/11/2022 |
MD/1228/11/2022 |
Eye Speculum 80mm (Article no: OA225R) (Brand: Aesculap) |
20 |
394979525, date: 31/10/2022 |
EUR 1,265.00 |
B. Braun Lanka (Pvt) ltd |
Aesculap AG - Germany |
For SPC (Not attached SPC Indent) |
Manufacturer registered with NMRA. No registered sources as per the NMRA database. |
Recommended only for this consignment. Advised to submit a SPC indent. |
||
2 |
05/12/2022 |
MD/1244/12/2022 |
Blood Lancet (Brand: Paramount) |
315,000 NOS |
LP/DHS/RL/EP/12/60WAC/22, date: 25/11/2022 |
LKR 1,827,000.00 |
Medica Pharmaceuticals (Pvt) ltd |
Paramount Surgimed Limited - India |
SPC Tender |
Manufacturer registered with Premium Healthcare up to 2019. |
Not recommended and advised to register the product. |
||
3 |
21/12/2022 |
MD/1279/12/2022 |
Cardiac Troponin I qualitative Strips |
7600 Strips |
LP/DHS/RL/EP/11/64SR/2022, date: 02/12/2022 |
LKR 3,724,000.00 |
Elshaddai Enterprises (Pvt) ltd |
Accurex INC - India. |
SPC Tender |
Manufacturer site registration has completed. |
Pending Decision. Advised SPC to submit tender documents and details of evaluation. |
||
4 |
21/12/2022 |
MD/1282/12/2022 |
ECG Recording Papers |
25 Pack + 1000 Roll |
LP/DHS/RL/EP/32/55SSN/2022, date: 11/11/2022 |
LKR 1,109,432.89 |
Biomedica (Pvt) ltd |
CMICS Medical Instruments Co.ltd - China |
SPC Tender |
Manufacturer is not registered. Not applied for registration yet. |
Pending Decision. Advised SPC to submit tender documents and details of evaluation. |
||
5 |
29/12/2022 |
MD/1293/01/2023 |
Immunohistochemistry Reagents (Brand: Dako Agilent) |
119 |
DHS/RL/33/25SM/21, date: 14/10/2022 |
US $ 73,538.88 |
A & M Suhada Enterprises (Pvt) ltd |
Agilent Technologies Singapore (International) Pte Ltd - Singapore |
SPC Tender |
Manufacturer is registered with NMRA. |
Pending Decision. Advised SPC to submit tender documents and details of evaluation. |
||
6 |
25/10/2022 |
MD/1176/10/2022 (MD/1135/10/2022) |
Pacing Lead (Brand: Medtronic, Model: 5076) , Rercutaneous Lead Introducer (Brand: Medronic, Model: 6207) |
900 NOS |
DHS/M/SS/WW/4/565DP/2021, date: 12/07/2022 |
US $ 562,500.00 |
Medrac (Pvt) ltd |
Medtronic Inc - USA |
SPC Tender |
Registered manufacturer site with Medtrac (Pvt) ltd. (SIL 4785/01/2022) Submitted to WOR Committee held on 08/10/2022 and Decision was Pending. Advised to request the registration certificate include the accessories. |
Submitted to WOR Committee held on 19/11/2022 Not recommended. Expedite the registration. Advised to request the registration certificate include the accessories. Submitted to WOR Committee |
CEO Decision. |
|
7 |
25/10/2022 |
MD/1177/10/2022 (MD/1136/10/2022) |
Rercutaneous Lead Introducer (Brand: Medtronic, Model: 6207, 6209) , Facing Lead (Brand: Medtronic, Model: 5076, 6935M) |
720 NOS |
DHS/M/SS/WW/5/573DP/2021, date: 22/07/2022 |
US $ 1,134,000.00 |
Medrac (Pvt) ltd |
Medtronic Inc - USA |
SPC Tender |
Registered with Medtrac (Pvt) ltd for "Vitatron MRI Surescan" single chamber pacemaker. (Ref:D-3388) (SIL under processing) |
CEO Decision. |
||
11/02/2023 |
|||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Approval |
1 |
09/01/2023 |
MD/1367/01/2023 |
Surgical Drapes and Gowns |
490 |
PI/2212301, date: 30/12/2022 |
USD 2,252.00 |
Zodiac Medicals (Pvt) ltd |
Careon Healthcare Solutions (Pvt) ltd - India |
For Patient and orthepedic surgeons |
NMRA registration under processing. (File Number: D/4384) Registered Manufacturer. Registered source available. |
Not recommended and advised to register the product. |
2 |
09/01/2023 |
MD/1368/01/2023 |
EEA Auto Suture, V Loc 180, Endo GIA |
As per the invoice |
6208941373, date: 05/12/2023 |
USD 6566.09 |
A. Baurs & Co. (Pvt) ltd |
Covidien LLC - USA |
For Government and Private Hospitals |
|
Recommended only for this consignment. Advised to submit registration documents for EEA Auto Suture. |
3 |
18/01/2023 |
MD/1370/01/2023 |
Hep G2 Cell Line Human |
1 |
8206222076, date: 23/08/2022 |
Eur 610.00 |
Dr. S.K.M.K. Herapathdeniya, University of Colombo, Institute of Indigenous Medicine. |
Sigma Aldrich, United Status |
For Research Purpose |
|
Recommended only for this consignment. |
4 |
13/01/2023 |
MD/1371/01/2023 |
Liquid Based Cytology Machine with GYN Trans Cyt Filters (Clear), Thinprep slide kit GYN Asian |
1 |
6508830, date: 05/01/2023 |
20000 |
Next-Vantage (Pvt) ltd |
Hologic Asia Pacific Limited - Hong Kong |
For Family Health Bureau |
|
Recommended only for this consignment. |
5 |
18/01/2023 |
MD/1373/01/2023 |
Intraoperative Bags (Brand : Dual Drawstring Bags) |
5 |
00074404, date:07/08/2022 |
$525.00 |
Apcot Marketing (Pvt) ltd |
Southern Cross Hospital Supplies - Australia |
For National Blood Transfusion Service |
|
Recommended only for this consignment. |
6 |
20/01/2023 |
MD/1374/01/2023 |
Automated External Defibrillator and Spare Parts |
6 |
10034184, date: 15/12/2022 |
USD 4165.98 |
Hemas Surgical & Diagnostics |
Nihon Kohden - Japan |
For Colombo International Container Terminals Limited. |
|
Recommended with condition. WOR granted for only spare parts. Dossier to be submitted for the defibrillator for registration. |
7 |
30/01/2023 |
MD/1376/01/2023 |
Hoya Intraocular Lens - Fortable |
1900 |
VSPI203790, date: 28/12/2022 |
USD 83925 |
Vision Solutions Lanka (Pvt) ltd |
Hoya Medical Singapore Pte. Ltd - Singapore |
|
|
Not recommended and advised to register the product. |
8 |
27/01/2023 |
MD/1378/01/2023 |
Blood and infusion warmer with / without Tube Flow and consumables (BW 685 blood & infusion warmer and extention set |
6 |
SO20232569, date: 16/01/2023 |
Euro 4,851.00 |
Emar Pharma (Pvt) ltd |
Biegler GmbH - Austria |
For Development of Kalutara Specialized Women & Children's Hospital. |
|
Recommended only for this consignment. |
9 |
08/02/2023 |
MD/1399/02/2023 |
Solberg Filter Cartridge, Expulsion Filter SV-CEG915-NW25/050HCB, OIL for Vaccume Pump AV-30 Container, 1220x610x69 LPD+LV+2GASKETS H14 Filter, Absolute Filter Hepa 610x457x69mm |
As per the invoice |
1120503, dated: 13/12/2022 |
1624.52 |
Institute of Biochemistry, Molecular Biology and Biotechnology, University of Colombo |
Azbil Telstar TEchnologies SLU - Spain |
For Research and Development Purpose |
|
Recommended only for this consignment. |
10 |
08/02/2023 |
MD/1400/02/2023 |
NTERA-2 cl.D1; Embryonal Carcinoma; Human (Homo Sapiens) |
1 |
SQ023275, date:02/01/2023 |
USD 1,199.85 |
Institute of Biochemistry, Molecular Biology and Biotechnology, University of Colombo |
American Type Culture Collection (ATTC) - USA |
For Research and Development Purpose |
|
Recommended only for this consignment. |
11 |
16/01/2023 |
MD/1369/01/2023 |
EEG Scanner |
1 |
460162, date : 31/10/2022 |
USD 2,318.95 |
Quantine Technologies (Pvt) ltd |
- |
Research Purpose. |
|
Pending Decision. Request to provide research proposal ethical clearance. |
12 |
08/02/2023 |
MD/1406/02/2023 |
Syringe Insulin 1ml/40IUw/Needle, 30Gx0.5", Pack of 12 Pieces. |
25 |
237007330, date: 27/01/2023 |
USD 2061.50 |
National STD/AIDS Control Programme |
Becton Dickinson International - Belgium |
Donation to STD/AIDS Control programme. |
|
Recommended only for this consignment. |
13 |
08/02/2023 |
MD/1407/02/2023 |
Determine HIV Early Detect Set 100T & Determine HIV ½ Serum/Plasma 100 Test/K. |
25 |
237007330, date: 27/01/2023 |
USD 2061.50 |
National STD/AIDS Control Programme |
Abbott Diagnostics Medical Co.ltd - Ireland. |
Donation to STD/AIDS Control programme. |
|
Recommended only for this consignment. |
11/02/2023 - S.P.C |
|||||||||||
1 |
18/01/2023 |
MD/1372/01/2023 |
Soft Cloth Liner tape |
28,398 |
LP/DHS/RS/EP/67434KC/2022, date: 11/01/2023 |
LKR 18444424.95 |
Shaka Holdings (Pvt) ltd |
Jinhua Jingdi Medical Supplies Co.ltd - China |
SPC Tender |
Manufacturer registered with another local agent (Rokem Pharmaceuticals) for Sink oxide surgical plaster in 2014. Registered source available. 3M Lanka (Sunshine), Shimmers. Valid registration. |
Not recommended and advised to register the product. |
2 |
27/01/2023 |
MD/1375/01/2023 |
Laboratory Consumables |
16 |
DHS/RL/98/28SSN/2021, date: 15/12/2022 |
US $ 10,443.00 |
State Pharmaceuticals Corporation of Sri Lanka |
M/s. Agilent Technologies Sigapore (Sales) Pte. Ltd - Singapore |
SPC Tender |
Manufacturer (M/s. Agilent Technologies - USA, M/s. Agilent Technologies - Denmark) registered with this local agent recently. (FMSA/MD/2021/71) |
Recommended with condition. Subject to summation of dossier for registration. |
3 |
29/12/2022 |
MD/1293/01/2023 |
Immunohistochemistry Reagents (Brand: Dako Agilent) |
119 |
DHS/RL/33/25SM/21, date: 14/10/2022 |
US $ 73,538.88 |
A & M Suhada Enterprises (Pvt) ltd |
Agilent Technologies Singapore (International) Pte Ltd - Singapore |
SPC Tender |
Manufacturer is registered with NMRA. Submitted to WOR Committee held on 06/01/2023 and Decision was Pending Decision. Advised SPC to submit tender documents and details of evaluation. |
Pending Decision. Advised SPC to submit tender documents & details of evaluation. |
4 |
29/08/2022 |
MD/1057/09/2022 |
Immunohistochemistry Reagents |
519 |
DHS/L/WW/81/014RS/22 |
US$ 16,555.40 |
A & M Suhada Enterprises (Pvt) ltd |
Agilent Technologies Singapore - Singapore / Agilent Technologies Inc - US |
SPC Order |
Appeal. Manufacturer not registered under NMRA. Submitted to WOR Committee held on 06/01/2023 and Decision was Not recommended. Expedite the registration. |
Recommended with condition. Subject to submission of the Dossier for registration. Advised SPC to submit SPC tender documents and TEC report. |
25/03/2023 |
|||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Approval |
1 |
15/02/2023 |
MD/1418/02/2023 |
Listed Medical Items |
As per the invoice |
0020006875, date: 20/12/2022 |
GBP 40,130.98 |
Mines Advisory Group |
SP Services (UK) Ltd - United Kingdom |
Ongoing Operations in Nothern and Eastern Province of the country.(Donation by HQ in UK) |
|
Recommended only for this consignment. |
2 |
21/02/2023 |
MD/1431/02/2023 |
Pharmacy Refrigerator (Brand: Haier, Model: HYC-310) |
2 |
HRP-005-Biomedica-2022, date: 2022/11/03 |
USD 1,320.00 |
Biomedica (Pvt) ltd |
Haier Biomedical Co.ltd - China |
For Office of the District Director of Health Services - Galle |
|
Recommended only for this consignment. |
3 |
28/02/2023 |
MD/1438/03/2023 |
1ml Syringe, 3ml Syringe, 10ml Syringe, 20ml Syringe and 60ml Syringe (Brand: Terumo) |
As per the invoice |
PFI-22/017, date: 08/02/2022 |
USD 3,387.60 |
Hemas Surgical & Diagnostics (Pvt) ltd |
Terumo Corporation - Japan |
Donation to Apeksha Hospital - Maharagama. |
|
Recommended only for this consignment. |
4 |
10/3/2023 |
MD/1444/03/2023 |
Real time Quantitative PCR (qPCR) based on Sso 7d fusion protein polymerase technology. (Brand: Sso Adv Universal Sybr SMX 1000. |
2 |
EP/BRD/LSG/01/2023, date: 06/03/2023 |
USD 1,210.00 |
Emar Pharma (Pvt) ltd |
Biorad Laboratories Inc - USA |
For Department of Medical Microbiology & Immunology, Faculty of Medicine, University of Colombo. (Research Purpose) |
|
Recommended only for this consignment. |
5 |
10/3/2023 |
MD/1447/03/2023 |
Ultra Low Freezer (Brand: Haier , Model: DW-86L578ST) |
1 |
HRP-001-BIOMEDICA-2023, date: 25/02/2023 |
USD 7,640.00 |
Biomedica (Pvt) ltd |
Haier Biomedical Co.ltd - China |
For University of Sabaragamuwa (Research Purpose) |
|
Recommended only for this consignment. |
6 |
10/3/2023 |
MD/1448/03/2023 |
Pacing Lead / Percutaneous Lead Introducer (Brand: Medtronic) |
900 |
6211877133, date: 27/02/2023 |
USD 680,400.00 |
Medrac (Pvt) ltd |
Medtronic - USA |
For Health System Enhancement Project |
|
Recommended only for this consignment. Advised to Expedite the registration. |
7 |
10/3/2023 |
MD/1449/03/2023 |
Consumables for FRC Facility |
125 |
FY23-SRI-0303002, date: 03/03/2023 |
USD 2,180.10 |
Emar Pharma (Pvt) ltd |
Haemonetics Corporation - USA |
For National Blood Transfusion Service |
|
Recommended only for this consignment. |
8 |
23/02/2023 |
MD/1432/02/2023 |
ACE-2 Fc Chimera, Human / SARS-COV-2 Spike Protein (Brand: Genscript) |
1 x 3 |
U7887HE260001, date: 13/07/2022 |
USD $ 707.67 |
Biomedite (Pvt) ltd |
Genscript Co.ltd - China |
For Faculty of Medical Sciences, University of Sri Jayewardenepura (Research use only) |
|
Recommended with condition. Subject to submission a valid letter of Ethical Review Committee. (Extension Letter) |
9 |
3/3/2023 |
MD/1452/03/2023 |
Welch Allyn Blood Pressure Monitor - 767 |
As per the invoice |
60384740, date: 01/11/2023 |
$11,114.00 |
A. Baur & Co. (pvt) ltd |
Welch Allyn - Mexico |
Donation (For Kaluthara District General Hospital) (By EN-Projects) |
|
Recommended only for this consignment. |
10 |
17/03/2023 |
MD/1462/03/2023 |
Administration Set of PD Solutions , PD Catheter Set |
3200 Sets |
UD/056 & 09/03/2023 |
& 70,400.00 |
MediGrow International SS (Pvt) Ltd |
Manish MedicInnovation - India |
For HSEP |
|
Not recommended and advised to register the product. |
11 |
16/03/2023 |
MD/1460/03/2023 |
Medical Devices/Equipments |
As per the invoice |
ZBS1-01/2023-DDP, ZBS1-02/2023-DDP, date: 17/02/2023 |
EUR 55,133.58 + EUR 2,800.00 |
Pfor. Inoka C.Perera, Department of Zoology and Environment Sciences, Faculty of Science, University of Colombo |
Robert Koch Institute - Germany |
For Research Purpose |
|
Recommended with condition. Subject to submission a valid letter of Ethical Review Committee. (Extension Letter) |
12 |
17/03/2023 |
MD/1463/03/2023 |
Phoenix M50 Instrument |
1 |
203067271 Rev.01, date: 20/02/2023 |
USD 34,000.00 |
Medical Research Institute |
BectonDickinson International - Belgium |
Donation from WHO to MRI |
|
Recommended only for this consignment. |
13 |
17/03/2023 |
MD/1464/03/2023 |
Vertical Autoclave with Drying |
2 |
203034820, date: 15/02/2023 |
USD 14,515.60 |
Medical Research Institute |
Amex Export-Import GmbH - Austria |
Donation from WHO to MRI |
|
Recommended only for this consignment. |
14 |
20/03/2023 |
MD/1467/03/2023 |
Hospital Beds and Mattresses |
70 + 40 |
885, date: 18/03/2023 |
AU & 3900.00 |
Miistry of Health |
Ceylon German Technical Training Institute Association - Australia |
For Government of Sri Lanka |
|
Recommended only for this consignment. |
15 |
20/03/2023 |
MD/1468/03/2023 |
Used Wheel Chair |
100 |
23-3-1, 01/03/2023 |
JPY 100,000.00 |
Sahana Sarana Social Welfare Foundation |
Nihon Shakaifukushi Kohsaikai - Japan |
Donation |
|
Pending decision. Advised to submit a distribution List with accepting letters. |
16 |
20/03/2023 |
MD/1465/03/2023 |
Troponin I Quantitative Test Device |
100 |
E00023185, date: 13/03/2023 |
USD 13,000.00 |
A.R.S. Healthcare (Pvt) ltd |
Quidel Cardiovascular Inc - USA |
For Government Hospitals |
|
Not recommended and advised to register the product. |
17 |
20/03/2023 |
MD/1466/03/2023 |
Fully preloaded, hydrophobic & Monofocal Intra Ocular Lenses with Injector System |
25000 |
DL/IOLs/25000/2023/02, date: 16/02/2023 |
EUR 2,000,000.00 |
Dimo (Pvt) ltd |
Carl Zeiss Meditec AG - Germany |
|
Not recommended. Expedite the registration. |
|
18 |
22/03/2023 |
MD/1469/03/2023 |
ECG Machine |
12 |
202451314, date: 06/02/2023 |
INR - 568,752.00 |
Ministry of Health |
World Health Organization -India |
Donation to government of Sri Lanka |
|
Recommended only for this consignment. |
19 |
22/03/2023 |
MD/1470/03/2023 |
HIV101 : HIV1/2 Stat Pak, 20 Test 60 Paks |
60 |
IN366493, date: 10/02/2023 |
$1,584.00 |
Ministry of Health (National STD/AIDS Control Programme) |
Chembio Diagnostics Systems Inc - United Status |
Donation to STD/AIDS Control Programme |
|
Recommended only for this consignment. |
20 |
22/03/2023 |
MD/1471/03/2023 |
Syphilis, First Response Anti-TP Card, Kit of 25 Test |
25 |
SCI/293/22-23, date: 24/02/2023 |
$10,937.50 |
Ministry of Health (National STD/AIDS Control Programme) |
Premier Medical Corporation (Pvt) ltd - India |
Donation to STD/AIDS Control Programme |
|
Recommended only for this consignment. |
21 |
22/03/2023 |
MD/1472/03/2023 |
Healthcare Products (Repellent, Deet 28% (Antibrum Forte), 150ml, spray btl, Repulsif Insecte, Deet 28%, (Antibrum Forte), 150ml, spray) |
3 |
AEGVAM2300339, date: 17/03/2023 |
CHF 1,707.85 |
International Committee of the Red Cross |
International Committee of the Red Cross - Geneva |
For ICRC Staff Members |
|
Recommended only for this consignment. |
22 |
23/03/2023 |
MD/1473/03/2023 |
Recombinant Insulin Glargine 100U/ml, Insulin Delivery Device for Lilly 3ml insulin cartridges, Insulin Hhuman Regular 100u/ml |
1724+1356+8970 |
80190979-Sri Lanka, date: 23/02/2023 |
USD $ 200.00 |
Sri Lanka College of Endocrinologists |
Direct Relief - U.S.A |
Donation to Sri Lanka College of Endocrinologists. |
|
Recommended only for this consignment. Subject to submission of No Objection Letter from Local Agent. |
23 |
24/03/2023 |
MD/1478/03/2023 |
Face Mask (tie-on type) |
1,625,000 NOS |
22-891, date: 20/03/2023 |
USD $ 49,020.11 |
Ministry of Health |
Poornima Healthcare - India |
Donation to government of Sri Lanka (From United Nations Office for Project Services - UNOPS) |
|
Recommended only for this consignment. |
24 |
27/12/2022 |
MD/1292/01/2023 |
Cysto-nephro Fiberscope (Brand: Olympus, Model: CYF-5A) |
1 |
RSI-FY2023-189R, date: 19/12/2022 |
SGD 8,077.12 |
Technomedics International (Pvt) ltd |
Olympus Medical Systems Corp - Japan |
For Clear the Shipment |
Appeal Submitted to WOR Committee held on 06/01/2023 and Decision was Not recommended. Expedite the registration. |
Recommended only for this consignment. |
25 |
30/01/2023 |
MD/1376/01/2023 |
Hoya Intraocular Lens - Fortable |
1900 |
VSPI203790, date: 28/12/2022 |
USD 83925 |
Vision Solutions Lanka (Pvt) ltd |
Hoya Medical Singapore Pte. Ltd - Singapore |
Appeal Submitted to WOR Committee held on 11/02/2023 and Decision was Not recommended and advised to register the product. |
Not recommended. Expedite the registration. |
25/03/2023 - S.P.C |
|||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Approval |
01 |
21/02/2023 |
MD/1430/02/2023 |
Electrode Jelly 260g Tube |
210,000 |
LP/DHS/RL/141/187WAC/21, date: 02/01/2023 |
LKR 33,390,000.00 |
Emar Pharma (Pvt) ltd |
Chhenna Corporation - India. |
SPC Tender |
Manufacturer registered with this local agent.
|
Recommended only for this consignment. |
02 |
17/03/2023 |
MD/1461/03/2023 |
Micro Dissector (Cat no:DD312R) , (Model: Aesculap) |
6 |
DHS/SUS/WW/122/183KM/22, date: 13/03/2023 |
EUR 540.36 |
B Braun Lanka (Pvt) Ltd |
Aesculap AG - Germany |
SPC Tender |
Registered Manufacturer. Not registered sources for Micro - Dissector. |
Recommended Only for this consignment. |
03 |
14/03/2023 |
MD/1454/03/2023 |
C Reactive Protein Latex Agglutination 100 Tests/Kit |
1000 |
DHS/ICL/X/RL/031/25SM/22, date: 28/10/2022 |
US$ 7,500.00 |
Elshaddai Enterprises (Pvt) ltd |
Genuine Biosystem (Pvt) ltd - India |
SPC ICL Tender |
|
Refer to MDEC. |
04 |
21/03/2023 |
MD/1474/03/2023 |
Pencil Point Spinal Needle, Extra long size 25G |
3900 |
DHS/ICL/X/RSS/040/95NB/2022, date: 28/09/2022 |
USD $ 5,109.00 |
State Pharmaceuticals Corporation of Sri Lanka (Local Agent : Sheild Medical (Pvt) ltd) |
M/s. Edges Medicare (Pvt) ltd - India |
SPC ICL Tender |
|
Refer to MDEC. |
05 |
21/03/2023 |
MD/1475/03/2023 |
Spinal Needle / Angiographic Catheter |
10110 |
DHS/ICL/X/RS/062/320DC/22, date: 06/10/2022 |
US $ 17,868.00 |
State Pharmaceuticals Corporation of Sri Lanka (Local Agent : Sheild Medical (Pvt) ltd) |
M/s. Edges Medicare (Pvt) ltd - India |
SPC ICL Tender |
|
Refer to MDEC. |
06 |
21/03/2023 |
MD/1476/03/2023 |
Dilatation Balloon Inflation Device |
200 |
DHS/ICL/X/RS/063/316DC/22, date: 06/10/2022 |
$4,200.00 |
(Local Agent : Sheild Medical (Pvt) ltd (Local Agent : Sheild Medical (Pvt) ltd) |
M/s. Edges Medicare (Pvt) ltd - India |
SPC ICL Tender |
|
Refer to MDEC. |
07 |
21/03/2023 |
MD/1477/03/2023 |
Epidural Anaesthesia Sets |
25,000 |
DHS/ICL/X/RS/061/420JT/22, date: 30/11/2022 |
$117,500.00 |
State Pharmaceuticals Corporation of Sri Lanka (Local Agent : Sheild Medical (Pvt) ltd) |
M/s. Edges Medicare (Pvt) ltd - India |
SPC ICL Tender |
|
Refer to MDEC. |
22/04/2023 |
|||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Recommendation |
1 |
29/03/2023 |
MD/1479/04/2023 |
Micro Surgical Instruments |
10 Nos x 7 |
EX-PI-22-0976, date: 17/02/2023 |
$1,220.00 |
Ministry of Health |
"Nethsetha" Lions Vision for Sight Hospital Trust |
Donation |
|
Pending recommendation. Refer to get opinion from End-user. |
2 |
09/03/2023 |
MD/1489/04/2023 |
Scalp Vein Set |
8000 |
A02587, date: 15/02/2023 |
45,885.00 |
Ministry of Health |
Chennai Surgicals - India |
For Lions Club of Colombo Waters Meet (Donation) |
|
Pending recommendation. Need clarification more data. 1. Requirement at MSD - with the distribution list. 2. Sample of Scalp Vein Set to be evaluated by the end-user. |
3 |
03/04/2023 |
MD/1490/04/2023 |
iCare TA01i Tonometer set, TA01i, Standard B |
30 Pcs |
119723, date: 28/03/2023 |
EUR 60,389.00 |
Ministry of Health |
Icare Finland Oy - Vantaa |
From Sight for All - Australia, humanitarian aid to Government of Sri Lanka. (Donation) |
|
Recommended only for this consignment. |
4 |
03/04/2023 |
MD/1491/04/2023 |
SUrgical Suture Materials (SeamCryl USP, SeamPDS USP, SeamLene USP) |
195 + 195 + 195 |
PI-EXP-2223-27, date: 28/03/2023 |
USD 5,063.00 |
Ministry of Health |
Surgical Sutures (Pvt) ltd - Bangalore |
Donation |
|
Recommended only for this consignment. |
5 |
03/04/2023 |
MD/1492/04/2023 |
ICU Hospital Beds / Wheel Chairs / Walkers / Commod Chairs / Crutches / Hospital Medical Trolly |
20 + 100 + 50 + 30 + 300 + 50 |
01042023, date: 01/04/2023 |
$1,200.00 |
Ministry of Health |
Mahakaruna Buddhist Society - Singapore |
Donation |
|
Recommended only for this consignment. |
6 |
04/04/2023 |
MD/1493/04/2023 |
Medical Devices/Equipments |
As per the invoice |
MS/CDS, date: 14/03/2023 |
INR 1,333,241.00 |
Ministry of Health |
World Health Organization - India |
Donation |
|
Recommended only for this consignment. |
7 |
06/04/2023 |
MD/1494/04/2023 |
Medical Devices/Equipments |
3 |
PE5588, date: 04/04/2023 |
USD 31,026.00 |
Ministry of Health |
Peak International Trade (Tianjin) Co.ltd - China |
Donation. (From United Nations Children's Fund) |
|
Recommended only for this consignment. |
8 |
10/04/2023 |
MD/1495/04/2023 |
Medical Devices/Equipments |
As per the invoice |
6205, date: 13/11/2022 |
As per the invoice |
Ministry of Health |
Ashiqe Medicals - India |
Donation (From Auslmat) |
|
Recommended only for this consignment. |
9 |
17/04/2023 |
MD/1496/04/2023 |
Blood Glucose Test Strips |
500,000 Pcs |
2023-24/0064, date: 05/04/2023 |
$60,000.00 |
Ministry of Health |
International Scientific Instrument Co. - New Delhi |
Donation (from United Nations Office for Project Services) |
|
Pending Recommendation. Need to confirm the compatibility with existing Glucometers in Sri Lanka. |
10 |
17/04/2023 |
MD/1500/04/2023 |
Face Mask (tie - on type) |
1,625,000 |
22-920, date: 28/03/2023 |
$49,020.11 |
Ministry of Health |
Poornima Health Care - India |
Donation (From UNOPS) |
|
Recommended only for this consignment. |
11 |
06/04/2023 |
MD/1501/04/2023 |
Model Premium RX 580 - Complete Medical Oxygen Generating Plant with Standard Accessories |
As per the invoice |
2110166, date: 29/09/2022 |
EUR 321,303.00 |
Ministry of Health |
Novair S.A.S - France |
Donation (From United Nations Children's Fund) |
|
Recommended only for this consignment. |
12 |
22/03/2023 |
MD/1480/04/2023 |
Liquid Nitrogen tank (35L & 30L) |
2 |
CO2604851, date: 27/02/2023 |
USD 1,157.14 |
Medical Research Institute |
Fleischhacker LLp - Singapore |
Donation from WHO |
|
Recommended only for this consignment. |
13 |
22/03/2023 |
MD/1481/04/2023 |
Crystal Violet 100g (01), Choroform Letter (02) |
3 |
2205028594, date: 06/07/2022 |
EUR 91.00 |
Medical Research Institute |
VWR International GmbH - Austria |
Donation from WHO |
|
Recommended only for this consignment. |
14 |
22/03/2023 |
MD/1482/04/2023 |
Heat Indicator tape (21), Micro test tube (02), FTA classic card pack (124), Polyester Sealing Film (05) |
As per the invoice |
258278, date: 27/01/2023 |
USD 20,860.40 |
Medical Research Institute |
Jalan Teknokrat 6 - Malaysia |
Donation from WHO |
|
Recommended only for this consignment. |
15 |
22/03/2023 |
MD/1483/04/2023 |
Bench Top Centrifuge with Rotor |
1 |
DPE/22-23/7434 Temp, date: 21/02/2023 |
USD 2,648.00 |
Medical Research Institute |
Deepak Care Limited - New Delhi |
Donation from WHO |
|
Recommended only for this consignment. |
16 |
03/04/2023 |
MD/1498/04/2023 |
Sterilizer - Sterilizer System and Spare Parts, Standard Accessories (Getinge HS 66 Hospital Steilizer) (Brand: Geting, Model: HS Series) |
As per the invoice |
8085413307, date: 17.03.2023 |
USD 8,529.69 |
Mediquipment Limited |
Getinge AB - Sweden |
For Biomedical Engineering Unit - Matara |
Existing Registration. (Ref: DVR-11509). Expired on 2019. |
Recommended only for this consignment. |
17 |
27/03/2023 |
MD/1488/04/2023 |
Medical Compression Stockings Anti - Embolism Stockings |
As per the invoice |
20230124.01, date: 06/02/2023 |
Eur 23,542.90 |
CIC Holdings PLC |
Varimed Medikal San - Turkiye |
Manufacturer not registered with NMRA. |
Not recommended and advised to register the product. |
|
18 |
30/03/2023 |
MD/1485/04/2023 |
Soft Roll / 100% Wrinkled Cotton Crape Bandage |
Soft Roll (4000Pcs + 2000Pcs) , 100% Coton Cepe Bandage (4800Pcs + 2400Pcs + 3200Pcs) |
SU20230324, date: 24/03/2023 |
US $ 5,467.84 |
Medica Pharmaceuticals (Pvt) Ltd |
Yangzhou Super Union Import & Export Co.ltd - China |
For Sri Lanka Army Medical Corporation |
Manufacturer is registered under NMRA with "Canoe Medicare (Pvt) ltd - Sri Lanka" for Surgical Face Masks. (Ref: number - D/2888) |
Not recommended and advised to register the product. |
19 |
14/03/2023 |
MD/1453/03/2023 |
Life Signals Multiparameter Remote Monitoring System and Spare Parts Accessories (Brand:Biosensor , Model LX 1550) |
50 |
01032023/HEMAS, date: 01/03/2023 |
$500.00 |
Hemas Surgical & Diagnostics ( Pvt) ltd |
Life Signals Inc - USA |
For Testing and Examination Purposes. |
Manufacturer is not registered under NMRA. |
Pending Recommendation. Submit a detail report of the study with the approved proposal, Ethic Committee Approvals, Letter from the study center, Details of the investigators etc. |
20 |
20/04/2023 |
MD/1504/04/2023 |
Laboratory Supplies (VTM) |
1 |
034/2023, PO: MS/WHE, date: 19/04/2023 |
USD 30.00 |
Ministry of Health |
World Health Organization - India |
Donation |
|
Recommended if it for Viral Transport Medium. If not the above, need additional information. Please confirm the name of the device. |
21 |
19/04/2023 |
MD/1505/04/2023 |
Module, Glucometer, 300 test with Lancets |
2000 |
203122051, date: 18/04/2023 |
USD 98,420.00 |
Ministry of Health |
World Health Organization - Malaysia |
Donation |
|
Recommended only for this consignment. |
22 |
20/04/2023 |
MD/1506/04/2023 |
LCD Oxygen Monitor |
40 |
23/00666, date: 07/03/2023 |
USD 28,783.90 |
Ministry of Health |
Amex Export-Import GmbH - Austria |
Donation |
Pending Recommendation. Advised to submit the recommendation from the end-user with the details of the product. |
|
23 |
21/04/2023 |
MD/1507/04/2023 |
Wheel Chairs / Clutches |
25 + 3 |
N/A |
N/A |
Ceylon Foiage (Pvt) ltd |
Takotomi Foundation - Japan |
For Boad of Investment of Sri Lanka and Divisional Hospital - Boralanda |
Recommended only for this consignment. |
|
24 |
21/04/2023 |
MD/1511/04/2023 |
Biological Safety Cabinet, Liquid Nitrogen Tank |
8 |
HRP-002-BIOMEDICA-2023, date: 20/03/2023 |
USD 7,010 |
Biomedica (Pvt) ltd |
Haier Biomedical Co.ltd - China |
For New Maternity Hospital - Galle |
Recommended only for this consignment. |
|
25 |
21/04/2023 |
MD/1512/04/2023 |
Spectra Optia Exchange Set, EA / Spectra Optia IDL Set |
6 + 4 |
950089652, date: 15/03/2023 |
7,800.00 |
Hemas Surgicals & Diagnostics (Pvt) ltd |
Terumo BCT Asia Pte. ltd - Singapore |
For National Blood Transfusion Service |
Recommended only for this consignment. (Registered product. Site change process in progress.) |
|
26 |
21/04/2023 |
MD/1513/04/2023 |
UN3373, Biological Substance, Category B Materials. |
01 Parcel |
AWB - 1541838255, date: 10/03/2023 |
- |
Medical Research Insitute |
Chulalongkorn University - Thailand. |
Donation |
Recommended only for this consignment. |
|
27 |
21/04/2023 |
MD/1514/04/2023 |
Phosphate Saline / Dimethyl Sulfoxide |
250 + 03 |
23/00835, date: 20/032023 |
USD 2688.40 |
Medical Research Insitute |
Amex Export-Import GmbH - Austria |
Donation |
Recommended only for this consignment. |
|
28 |
16/03/2023 |
MD/1460/03/2023 |
Medical Devices/Equipments |
As per the invoice |
ZBS1-01/2023-DDP, ZBS1-02/2023-DDP, date: 17/02/2023 |
EUR 55,133.58 + EUR 2,800.00 |
Pfor. Inoka C.Perera, Department of Zoology and Environment Sciences, Faculty of Science, University of Colombo |
Robert Koch Institute - Germany |
For Research Purpose |
Submitted to WOR Committee held on 25/02/2023 and Decision was Recommended with condition. Subject to submission a valid letter of Ethical Review Committee. (Extension Letter).
An extension has been applied for but the MRI Ethics Committee has not yet met and has been informed that there are technical issues in convening it. WOR is requested on the condition of granting the extension. |
Recommended with condition. Subject to submission of Official letter confirming current situation given in the email. (Can be issued. There is an official letter confirming current situation given in the email.) |
22/04/2023 - S.P.C |
|||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Recommendation |
1 |
30/03/2023 |
MD/1484/04/2023 |
Cilia Forceps (Duckworth & Kent) |
50 Nos |
DHS/RS/RQ/181/21, date:25/03/2023 |
LKR 4,875,000.00 |
Mervynsons (Pvt) ltd |
Dockworth & Kent Ltd - UK |
SPC Tender |
Dossier Submitted for product registration - Not evaluated. (D/4032) Manufacturer is registered under NMRA with Hemas Pharmaceuticals for different product. |
Recommended only for his consignment. |
2 |
3/4/2023 |
MD/1502/04/2023 |
Anticoagulant Solution 500ml |
3000 |
LP/DHS/SUS/WW/1/07NB/2023, date: 07/03/2023 |
LKR 195,000,000.00 |
Emar Pharma (Pvt) ltd |
Haemonetics SA - Switzerland |
SPC Tender |
Haemonetics S.A - Switzerlandis available as a legal manufacturer for different products registered with Emar Pharma. (Ref: D/488, D/489) |
Recommended only for this consignment. |
30/05/2023 |
|||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks WOR Committee Recommendation |
|
01 |
19/05/2023 |
MD/1554/05/2023 |
Medical Devices/Equipments |
As per the invoice |
Equip-Charity-16, date: 06/04/2023 |
E 4,770.00 |
Meththa Foundation |
Meththa Foundation - UK |
For Meththa Foundation |
Recommended only for this consignment. Advised to submit the distribution list. |
|
02 |
12/05/2023 |
MD/1550/05/2023 |
Long Bulb Celcius Clinical Thermometer |
120 |
57738, date: 02/03/2022 |
|
Hunter & Company PLC |
G H Zeal Ltd - UK |
For |
Not recommended and advised to register the product. |
|
03 |
25/04/2023 |
MD/1517/05/2023 |
Spare Parts for Hematology Analyzer (Brand: Nihon Kohden Japan) |
As per the invoice |
10038850, date: 18/04/2023 (PO:5500015089) |
USD 30,066.28 |
Hemas Surgicals & Diagnostics (Pvt) ltd |
Nihon Kohden - Japan |
For Sri Lanka Air Force Headquarters |
Recommended only for this consignment. |
|
04 |
12/05/2023 |
MD/1548/05/2023 |
Spare Parts for EEG and ECG Machine (Brand: Nihon Kohden) |
As per the invoice |
10038946, date: 20/04/2023 |
USD 23,473.44 |
Hemas Surgicals & Diagnostics (Pvt) ltd |
Nihon Kohden - Japan |
For Several government Hospital in Sri Lanka. (District General Hospital-Matara, teaching Hospital - Batticaloa, Teaching Hospital - Anuradhapura, Teaching Hospital - Kurunegala) |
Recommended only for this consignment. |
|
05 |
12/05/2023 |
MD/1549/05/2023 |
Controls, Calibrators and Reagents for Hemotology Analyzer |
As per the invoice |
10038132, date: 24/03/2023 , MYU-76-2023, date: 07/04/2023 |
USD 26,867.00 + USD 775.00 |
Hemas Surgicals & Diagnostics (Pvt) ltd |
Nihon Kohden - Japan |
For Sri Lanka Air Force and Department of Health Service-North Western Province |
Recommended only for this consignment. |
|
06 |
25/04/2023 |
MD/1519/05/2023 |
BIT CD EMRLD 22 LYSE (Brand: Abbott) |
15 |
ADD/PF/A632/2023/PAK/GMBH, date: 29/03/2023 |
US $ 1260.00 |
Hemas Surgicals & Diagnostics (Pvt) ltd |
Abbott Laboratories - USA |
For Asiri Hospital Holdings PLC - Anuradhapura |
Not recommended. Expedite the registration. |
|
07 |
08/05/2023 |
MD/1538/05/2023 |
Blood Plasma Freezer |
2 |
178/00, date: 27/02/2023 |
8,980.00 |
Premium International (Pvt) ltd |
KW Apparecchi Scientifici S.R.L - Italy |
For Karapitiya Maternity Hospital |
Recommended only for this consignment. |
|
08 |
08/05/2023 |
MD/1531/05/2023 |
Blood Bag Refrigerator |
2 |
178/00, date: 27/02/2023 |
6,100.00 |
Premium International (Pvt) ltd |
KW Apparecchi Scientifici S.R.L - Italy |
For Karapitiya Maternity Hospital |
Recommended only for this consignment. Advised to apply for registration. |
|
09 |
08/05/2023 |
MD/1532/05/2023 |
Vertical Autoclave |
1 |
XHC230302002, date: 17/03/2023 |
USD 1,275.00 |
Premium International (Pvt) ltd |
Shinva Medical Instrument CO.ltd - China |
For Karapitiya Maternity Hospital |
Not recommended and advised to register the product. |
|
10 |
08/05/2023 |
MD/1533/05/2023 |
Endoscope Washer-disinfector |
1 |
XHC230220003, date: 17/03/2023 |
USD 13,358.00 |
Premium International (Pvt) ltd |
Shinva Medical Instrument CO.ltd - China |
For Karapitiya Maternity Hospital |
Not recommended and advised to register the product. |
|
11 |
08/05/2023 |
MD/1535/05/2023 |
Centrifuges and Accessories |
As per the invoice |
HI-TE-030-1, date: 27/04/2023, HI-TE-030-2, date: 27/04/2023 |
EUR 41,280.00 + EUR 25,220.00 |
Premium International (Pvt) ltd |
Hetich Asia Pacific Pte Ltd - Singapore |
For Karapitiya Maternity Hospital |
Not recommended and advised to register the product. |
|
12 |
23/05/2023 |
MD/1565/05/2023 |
Upright Laboratory Freezer (KW Apparecchi Scientifici - KBPF 600PP PL ADV) |
1 |
178/00, date: 27/02/2023 |
4,750.00 |
Premium International (Pvt) ltd |
KW Apparecchi Scientifici S.r.L. - Italy |
For Karapitiya Maternity Hospital |
Recommended only for this consignment. Advised to apply for registration. |
|
13 |
23/05/2023 |
MD/1566/05/2023 |
Upright Refrigerator (KW Apparecchi Scientifici - KBPR 600V NG, KBPR 400V NG) |
15 + 8 |
178/00, 27/02/2023 |
21,750.00 + 10,800.00 |
Premium International (Pvt) ltd |
KW Apparecchi Scientifici S.r.L. - Italy |
For Karapitiya Maternity Hospital |
Recommended only for this consignment. Advised to apply for registration. |
|
14 |
23/05/2023 |
MD/1567/05/2023 |
HLA Transplant Reagents and Consumables |
As per the invoice |
P1014000163, date: 18/05/2023 |
As per the invoice |
Premium International (Pvt) ltd |
Immucor GTI Diagnostics Inc - USA |
For National Blood Transfusion Services |
Not recommended. Expedite the registration. (Already two registered sources available and sample license already issued.) |
|
15 |
25/05/2023 |
MD/1569/05/2023 |
Tissue Embedding System |
2 |
230500034, date: 19/05/2023 |
As per the invoice |
Premium International (Pvt) ltd |
Sakura Finetek Japan Co.ltd - Tokyo |
For Department of Health Services - Sabaragamuwa Province. |
Not recommended. Expedite the registration. (Sample license already issued.) |
|
16 |
08/05/2023 |
MD/1536/05/2023 |
Sterilizer System and Spare Parts, Standard Accessories (Getinge Syeam Sterilizer) |
4 |
8085412348, date: 14/09/2023 |
USD 541.36 |
Mediquipment Limited |
Getinge Sterilization AB - Sweden |
For Wathupitiwala Base Hospital and General Sir John Kotelawala Defence University Hospital |
Recommended only for this consignment. |
|
17 |
08/05/2023 |
MD/1537/05/2023 |
Sterilizer System and Spare Parts, Standard Accessories (Getinge Syeam Sterilizer) |
As per the invoice |
8085413437, date: 10/04/2023 and 8085413426, date: 06/04/2023 |
USD 892.28 + USD 13795.94 |
Mediquipment Limited |
Getinge Sterilization AB - Sweden |
For Wathupitiwala Base Hospital and Kalmunai Base Hospital |
Recommended only for this consignment. |
|
18 |
12/05/2023 |
MD/1543/05/2023 |
Lab Consumables |
As per the invoice |
2000926395, date: 25/04/2023 |
USD 1646.24 |
A. Baur & Co. (Pvt) ltd |
Becton Dickinsons Co.- USA |
For Department of Clinical Medicine, Faculty of Medicine, University of Colombo |
Recommended only for this consignment. |
|
19 |
23/05/2023 |
MD/1560/05/2023 |
Wallace Catheters & Oocyte Recovery Set |
420 |
OIPL/23-24/PI/AB/001, date: 27/04/2023 |
$29,652.00 |
A. Baur & Co. (Pvt) ltd |
Cooper Surgical Inc - USA |
For Several Private Hospitals in Sri Lanka |
Not recommended and advised to register the product. (Manufacture registered with another local agent.) |
|
20 |
12/05/2023 |
MD/1551/05/2023 |
Micromanipulation Ppettes (Vitrolife) (ICSI Pippetes, Holding Pipettes) |
44 + 55 |
454492, date: 2023/05/09 |
EUR 7640.00 |
A. Baur & Co. (Pvt) ltd |
Vitrolife Inc - USA |
For Several Private Hospitals in Sri Lanka |
Not recommended. Expedite the registration. |
|
21 |
23/05/2023 |
MD/1562/05/2023 |
Elisa Test Kits |
4 |
899069, date: 12/05/2023 |
$2,075.00 |
Emar Pharma (Pvt) ltd |
My BioSource Inc - USA |
For Ministry of Higher Education Technology and Innovation |
Recommended only for this consignment. |
|
22 |
25/05/2023 |
MD/1571/05/2023 |
FLAER (Alexa 488 Proaerolysin Variant) |
4 |
1074122, date: 18/05/2023 |
USD 1,170.00 |
Emar Pharma (Pvt) ltd |
Cedarlane Corporation - Canada |
For Medical Research Institute |
Recommended only for this consignment. |
|
23 |
14/03/2023 |
MD/1453/03/2023 |
Life Signals Multiparameter Remote Monitoring System and Spare Parts Accessories (Brand:Biosensor , Model LX 1550) |
50 |
01032023/HEMAS, date: 01/03/2023 |
$500.00 |
Hemas Surgical & Diagnostics (Pvt) ltd |
Life Signals Inc - USA |
For Testing and Examination Purposes. |
Submitted to WOR Committee held on 22/04/2023 and Decision was Pending Recommendation. Submit a detail report of the study with the approved proposal, Ethic Committee Approvals, Letter from the study center, Details of the investigators etc. |
Pending decision. Instructed to submit reports for product with prior WOR approval. |
24 |
12/05/2023 |
MD/1544/05/2023 |
Administration Set for Peritoneal Dialysis Solution with two lead / Peritoneal dialysis catheter set for Peritoneal dialysis and Peritoneal lavage |
1600 + 1600 |
UD/056, date: 09/03/2023 |
USD 70,400.00 |
Medigrow International SS (Pvt) ltd |
Manish Medi Innovation - India |
For Health System Enhancement Project |
Appeal
Submitted to WOR Committee held on 25/03/2023 and Decision was Not recommended and advised to register the product. |
Not recommended and advised to register the product. |
25 |
10/05/2023 |
MD/1568/05/2023 |
H2 O2 Hydra Facial Machine (Home Skin Care) |
1 |
XMBR78096663, date: 21/04/2023 |
USD 284.13 |
Dr. D.G.I.N. Wijerathne |
SZ XH Import & Export Co. Ltd - China |
For Anesthetic Medical Praing Programme for doctors. |
Not recommended and advised to register the product. |
|
26 |
20/04/2023 |
MD/1506/04/2023 |
LCD Oxygen Monitor |
40 |
23/00666, date: 07/03/2023 |
USD 28,783.90 |
Ministry of Health |
Amex Export-Import GmbH - Austria |
Donation |
Submitted to WOR Committee held on 22/04/2023 and Decision was Pending Recommendation. Advised to submit the recommendation from the end-user with the details of the product. |
Pending decision. NMRA was instructed to evaluate the sample with Ceylon Oxygen (Pvt) Ltd. |
30/05/2023 - S.P.C |
||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
WOR Committee Recommendation |
1 |
21/04/2023 |
MD/1510/04/2023 |
Oxygen Masks / Hudson Mask with tubing for adult |
150,000 NOS |
LP/DHS/RS/EP/61/486AK/22, date: 06/04/2023 |
LKR 41,250,000.00 |
Sethmedi International (Pvt) ltd |
Guangdong Ecan Medical Co.ltd - China |
SPC Tender |
Not recommended and advised to register the product. Advised to submit the samples for end-user evaluation. (College of Anesthesiologists) |
2 |
10/04/2023 |
MD/1499/04/2023 |
Activated partial thromboplastin time reagent (lupas sensitive) with calcium |
260+65 |
LP/DHS/RL/EP/25/83SR/22, date: 01/02/2023 |
LKR 1,770,678.00 |
Biomedite (Pvt) ltd |
Technoclone Herstellung Von Diagnostika und Arzneimtteln GmbH - Austria |
SPC Tender |
Not recommended. Advised to purchase from registered source. (Registered source available.) |
3 |
12/05/2023 |
MD/1552/05/2023 |
Trabecular Metal Implants for Revision Hip Surgery (Zimmer) |
100 |
DHS/RSS/RQ/191/611BS/21, date: 04/10/2022 |
US $ 578,400.00 |
Zodiac Medicals (Pvt) ltd |
Zimmer (Pte) ltd |
SPC Tender |
Recommended only for this consignment. |
4 |
13/02/203 |
MD/1421/02/2023 |
"8" Instrument Set for figure eight bone plates in sterilizing tray with 100 implants |
18 NOS |
LP/DHS/SUS/WW/206/583KM/21, date: 29/08/2022 |
LKR 49,788,000.00 |
Medisurge International |
Sigma Surgical (Pvt) ltd - India |
SPC Tender |
Recommended only for this consignment. Subject to submission of the renewal. |
Waiver of Registration Committee - Medical Device (July 2022 to December 2022) |
||||||||||
13/07/2022 |
||||||||||
|
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Approval |
1 |
15/06/2022 |
MD/831/06/2022 |
Main Stretcher , Foldaway Stretcher(for ford ambulances),
|
|
N/A |
Future Automobiles (Pvt) ltd |
Jiangsu Rixin Medical Equipment co.ltd - China
|
For Ministry of Health (Not a DonatHeion) |
Manufacturer is registered under NMRA with Local Agent "Access international". (No current valid registrations for the product.)
ISO, EC certificates and registration document of US FDA are submitted |
Not recommended. Need a recommendation from college of anesthesiology. Advised to arrange an inspection with college members of anesthesiology. |
|
Same as above |
Same as above |
Portable Oxygen Therapy Kit, |
|
N/A |
Same as above |
Medbirlesim - Turkey |
For Ministry of Health (Not a Donation) |
Manufacturer not registered
ISO, EC certificates are submitted. |
|
|
Same as above |
Same as above |
First Aid Bag (for ford ambulances), |
|
N/A |
Same as above |
Medbirlesim - Turkey |
For Ministry of Health (Not a Donation) |
Manufacturer not registered
ISO, EC certificates are submitted. |
|
|
24/06/2022 |
MD/837/06/2022 |
Motivation Multisport Wheelchair (Brand : Merits, Model : WM4SP-02)) |
20 |
SI002783, date: 13/06/2022 |
Sri Lanka Tennis Association |
Merits (China) under license from Motivation (UK) |
Donation From ITF to the SLTA with the aim of further developing Wheelchair Tennis in Sri Lanka. |
Manufacturer not registered under NMRA. |
Recommended only for this consignment. |
3 |
22/06/2022 |
MD/838/06/2022 |
Cervial Collars, Rigid Splint Cervical Collors and Collar with Trache Opening (Brand: OPPO) |
2775 |
OP01-202204011, date: 29/04/2022 |
Hemas Surgical & Diagnostics (Pvt) ltd |
OPPO Medical Corporation - Taiwan |
|
Already registered product. (File: D/147/RR)
Manufacturing site changed and new site is registered with NMRA very reason. (File: T/174) |
Not recommended and advised to register the product. |
4 |
23/06/2022 |
MD/842/06/2022 |
Phacoemulsification Stem with accessories & Spare Parts (Brand : White star Signature PRO) / Life Signals multipara meter remote monitoring system and spare parts Accessories |
1 + 14 |
199055, date : 2/11/2021, 24032022/HEMAS, date: 24/03/2022 |
Hemas Pharmaceuticals (Pvt) ltd |
Johnson & Johnson Surgical Vision Inc - USA / Life Signals Inc - USA |
For Whitestar Signature PRO System / For Testing and Examination Purpose. |
· Accessories for already registered Item. (File D/1905) · These are supplied on free of charge basis for the purpose of variant replacement. |
Recommended only for this consignment. |
5 |
22/06/2022 |
MD/844/06/2022 |
Air Mettress (Brand: Fitconn, Model: FU-AM001) |
2700 |
P22309JN151, date: 09/03/2022 |
Medica Pharmaceuticals (Pvt) ltd |
Shenzhen Fitvonn Technology Co.ltd - China |
to cover the shortage in Sri Lanka Market |
Manufacture is not registered with NMRA. Registered sources available. |
Not recommended and advised to register the product. |
6 |
22/06/2022 |
MD/845/06/2022 |
Wheelchairs |
328 |
HBDS2204297152, date: 2022/04/29 |
Medica Pharmaceuticals (Pvt) ltd |
Hebei Dansong Medical Equipment Co.ltd - China |
to cover the shortage in Sri Lanka Market |
Manufacture is not registered with NMRA. Registered sources available. |
Not recommended and advised to register the product. |
7 |
22/06/2022 |
MD/846/06/2022 |
Portable Otoacoustic Test Device(OtoRead) |
N/A |
N/A |
J.M. Wickramarachchi & Company (Pvt) ltd |
Interacoustics A/S - Denmark |
For Biomedical Engineering Services |
Manufacturer registered with NMRA. |
Recommended with condition. Subject to submission of dossier for registration. |
8 |
15/06/2022 |
MD/847/06/2022 |
Premium Plus CEEA, GIA, Endo GIA, VOLC180, Protack, TA |
As per the invoice |
6202313769, date: 27/05/2022 |
A. Baur & Co. (Pvt) ltd |
Covidien LLC - USA |
For Government and Private Hospitals |
Agency Transfer from Ceyoka to A Buars. Copy of registration certificate issued to previous local agent not submitted. |
Recommended with condition. Subject to NOL from Ceyoka (Pvt) ltd. |
9 |
05/07/2022 |
MD/859/07/2022 |
Laboratory reagents and supplies |
As per the invoice |
date: 27/06/2022 |
Dr. Lakkumar Fernando |
Johns Hopkins Bloomberg School of Public Health - USA |
For Research Purpose |
Donation |
Recommended only for this consignment. |
10 |
05/07/2022 |
MD/860/07/2022 |
Reagents for Hematology Analyzer |
750 |
5500014368, date: 21/06/2022 |
Hemas Surgical & Diagnostics (Pvt) ltd |
Nihon Kohden Japan |
For Sri Lanka Air Force Headquarters |
- |
Recommended only for this consignment. |
11 |
30/06/2022 |
MD/862/07/2022 |
Urine Reagent Strips (10 parameter) test kits |
200 |
47709, date: 28/04/2022 |
DN Medical Corporation (Pvt) ltd |
Cortez Diagnostics Inc - USA |
For Government Institution and Pricat Sector (Diabetes Association of Sri Lanka, General Sir John Kotelawala Defence University, Gall Co-op Hospital ltd, Ohlums Clinic & Laboratories (Pvt) ltd, Medna Healthcare, Dhanvantharii Hospital - Trincomalee, Wayamba Medical Center, C-Care Pharmacentical - Kandy, Medi-Care - rathnapura.) |
Already registered item and site changed. (DVR 360 RR) Valid till Dec.2022. SIL applied for new product. |
Not recommended. Expedite the registration. |
12 |
30/06/2022 |
MD/863/07/2022 |
Urine HCG Pregnancy Rapid Test Kits (Brand : Insta Test) |
30000 |
47709, date: 28/04/2022 |
DN Medical Corporation (Pvt) ltd |
Cortez Diagnostics Inc - USA |
For Government Institution and Pricat Sector (Lanka Hospital - Colombo 5, Galle Co-Op Hospital ltd, Cargills Foods Company (Pvt) ltd, Sri Jayawardenepra General Hospital, Ohlums Clinic & Laboratories (Pvt) ltd, HEMAS - wattala, Healthguard Pharmacy Ltd - Kelaniya, Richard Pieris Distributors Ltd, C-Care Pharmacentical - Kandy, Medna Health Care - Puwakpitiya, Wayamba Medical Center, Dhanavantharii Hospital - Trincomalee, Medi Care - Rathnapura) |
Already registered product. (DVR 157 RR) and expedited may 2022. Manufacturer site changed and SIL applied to submit fresh file. |
Not recommended. Expedite the registration. |
13 |
01/07/2022 |
MD/864/07/2022 |
Video Colonoscopy (Brand:Olympus, Model:CF-Q150L) |
1 |
RPI-FY2023-008, date: 21/06/2022 |
Mediquipment Limited |
Olympus Medical Systems Cooperation - Japan |
Repaired Item (For Ruhunu Hospital (Pvt) ltd) |
Repaired Items. |
Recommended only for this consignment. |
14 |
05/07/2022 |
MD/867/07/2022 |
Platelet Aggregometer with standard accessories (Brand: Helena) |
As per the invoice |
318657, date: 17/05/2022 |
Analytical Instruments |
Helena Bioscience Europe - United Kingdom |
For Medical Research Institute and Teaching Hospital - Peradeniya. |
Renewal is under processing. (D/1136RR) Expired June 2022. |
Recommended only for this consignment. |
15 |
05/07/2022 |
|
Medical Devices/Equipments |
As per the invoice |
3977184, date: 03/06/2022 |
Prof. Prasanna Galhena, Director, Institue of Biochemistry, Molecular Biology and Biotechnology, University of Colombo |
Agilent Technologies - Singapore |
For Research and Development Purpose and not for human diagnostic or therapeutic use. |
Donation |
Recommended with condition. Subject to submission of Ethic Committee Clearance Letter. |
16 |
01/07/2022 |
MD/854/07/2022 |
Hospital Beds |
As per the invoice |
22HC132A, date: 6/6/2022 |
AP Lanka (Pvt) ltd |
Ningbo Hecai Medical Equipment Co.ltd - China |
For Sri Jayewardenepura General Hospital and Postgraduate Medical Training Center |
Donation |
Recommended only for this consignment. |
17 |
08/07/2022 |
MD/869/07/2022 |
QFT-Plus 2 Plate Kit ELISA, QFT- Plus tubes. |
20 |
93394498, date:22/06/2022 |
Microtech Biological (Pvt) ltd |
QIAGEN GmbH - Germany |
For several Private Hospitals. |
As per the data base registration (D/1248) still not recommended by the panel. Need to check the file. The local agent submitted additional data. |
Not recommended. Expedite the registration. |
18 |
08/07/2022 |
MD/870/07/2022 |
Sterilizer System and Standard Accessories, Spare Parts. |
03 |
8085411955, date: 28/06/2022 |
Mediquipment Limited |
Getinge Sterilization AB - Sweden. |
Repaired Item.
For Regional Director of Health Services - Gampaha and Asiri Hospital - Kandy. |
Registered product and expired. Also product discussed by the manufacture. (DVR 11509) Regulating to import spare parts to repair already supplied machines at RDHS-Gampaha and Asiri Hospital. |
Recommended only for this consignment. |
19 |
08/07/2022 |
MD/871/07/2022 |
GeneXpert MTB/RIF Kit and MTB/RIF Ultra Kit |
As per the invoice |
9001103080, date: 24/05/2022 |
National Programme for Tuberculosis Control & Chest Diseases |
UNOPS |
Donation to TB |
Donation |
Recommended only for this consignment. |
20 |
08/07/2022 |
MD/872/07/2022 |
Detection Kits for real time PCR |
13 |
0000702270, date: 21/06/2022 |
Emar Pharma (Pvt) ltd |
Primer Design Ltd - UK |
For Asiri Surgical Hospital - Colombo 05 |
New manufacturer not registered under NMRA. |
Not recommended and advised to register the product. |
21 |
08/07/2022 |
MD/873/07/2022 |
Viral Medium Transport Kits |
1000 |
7121300634, date: 05/03/2022 |
Siba Holdings (pvt) ltd |
Meril Diagnostics (Pvt) ltd - India |
|
D/3986 is pending for panel evaluation. |
Not recommended. Expedite the registration. |
22 |
08/07/2022 |
MD/874/07/2022 |
Solas Liferaft/Lifeboat First Aid Kit |
60 |
|
C.G.V. Antony & Sons (Pte) Ltd |
BCB International Ltd - UK |
Imported to export ships use. |
|
Recommended only for this consignment. |
23 |
09/05/2022 |
MD/784/05/2022 |
Hyperbaric Oxygen Therapy |
1 |
RE2022-026P, date: 27/04/2022 |
Analytical Instruments |
Haux-Life-Support GmbH - Germany |
For Ministry of Defence |
Manufacturer is not registered. WOR Committee held on 11/06/2022 and committee decision was Not recommended and advised to register the product. Apply for registration to expedite. |
Pending Decision. Get an opinion from College of Physicians. |
24 |
9/9/2021 |
MD/07/09/2021 |
Oxygen Production Plant, Generator (Oxymat - Slovakia) |
1 |
Tender Number:UNOPS-22900-EPP-030R, date:02/09/2021 |
Delmege Forsyth & Co.ltd |
Process Engineering S.r.l - Milano |
UNOPS Tender.
|
WOR Committee held on 11/12/2021 and committee decision was Pending Decision. Committee advised to send a letter Director DGHS, Director - BMES and Director - Logistics. Biomedical Engineering Services sent a reply to this. |
Pending Decision. Advised to send a letter Director (Building), Ministry of Health for evaluate the product. |
13/07/2022 - S.P.C |
||||||||||
|
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Approval |
1 |
22/06/2022 |
MD/839/06/2022 |
Urinary Catheter / Clean Intermittent Catheterization Catheter (CIC Catheter) (Brand: Devon CIC) |
5970 |
DHS/ICL/X/RSS/001/39NB/2022, date: 07/06/2022 |
R & D Intertrades (Pvt) ltd |
Devon Innovations (Pvt) ltd - India |
SPC Tender (Under Indian Credit line) |
· For SPC Supply. · Registration expired in 2017 and not apply for renewal. (File DVR-417-RR) · Sample import license issued recently to submit new file, but file still not submitted. · SPC not submitted TEC Document. |
Recommended with condition. Expedite the registration or Subject to submission of SPC TEC Document. |
2 |
22/06/2022 |
MD/840/06/2022 |
Bladder Drainage (Urethral) Catheter |
2000 |
DHS/ICL/X/RSS/001/33NB/22, date: 06/06/2022 |
Medica Pharmaceuticals (Pvt) ltd |
Leelavathy Medical Devices Company - India |
SPC Tender (Under Indian Credit line) |
· For SPC. · New manufacturer not registered with NMRA. · SPC not submitted TEC Document. · Registered sources available. |
Recommended with Condition. Subject to submission of TEC Documents. |
3 |
23/06/2022 |
MD/841/06/2022 |
Dental Instruments (Dental Probs, Dental Hand Scaler, Gum Scissors, Excavator, Osteo-Mitchell Carver) (Brand: Snaa) |
As per the invoice |
DHS/S/WW/208/21, date: 29/09/2020 |
Rivomed Holdings (Pvt) ltd |
Snaa Industries - Pakistan |
SPC Tender
|
· Manufacturer registered with another local agent Indro (Pvt) ltd As per NMRA database. · SPC submitted TEC Document. |
Not recommended and advised to register the product. |
4 |
23/06/2022 |
MD/843/06/2022 |
Un cuffed/ cuffed Endotracheal Tubes Nylon/Steel Reinforced |
As per the invoice |
DHS/ICL.X/RS/038/2022, date: 31/03/2022 |
Nextgen Healthcare |
La-Med Healthcare Pvt ltd - India |
SPC Tender (Under Indian Credit line) |
· For SPC. · Manufacturer already registered with this local agent. · SPC submitted TEC Document. |
Recommended with condition. Subject to submission of Letter of award. |
5 |
05/07/2022 |
MD/861/07/2022 |
Fully Automated Biopsy Gun |
As per the indent |
DHS/ICL/X/RS/036/2022, date: 31/03/2022 |
Kish International (Pvt) ltd |
St. Stone Medical Devices (Pvt) ltd |
SPC Tender (Under Indian Credit line) |
· SPC not submitted TEC Document. · Manufacturer registered with NMRA. |
Recommended with condition. Subject to submission of TEC documents and SPC Letter of award. |
6 |
08/07/2022 |
MD/875/07/2022 |
Peritoneal Dialysis Catheter/ Peritoneal Dialysis Catheter Sets |
As per the indent |
DHS.ICL/X/RSS/016/43PL/22, date: 16/06/2022 |
MediGrow International SS (Pvt) ltd |
Manish Medi Innovation - India |
SPC Tender (Under Indian Credit line) |
· SPC not submitted TEC Document. · Manufacturer not registered with NMRA. · Three registered sources available. |
Recommended with condition. Subject to submission of TEC documents and letter of award. |
7 |
27/05/2022 |
MD/802/06/2022 |
Riboflavin Solution for Control Cross-Linking (CXL) |
400 |
DHS/P/WW/324/22, date: 09/11/2021 |
Lenstech Innovations (Pvt) ltd |
Ophthalmica (Pty) Ltd - South Korea |
SPC Tender
|
Manufacturer not registered with NMRA. WOR Committee held on 11/06/2022 and committee decision was Not coming Under NMRA. Issue Product Categorization. |
Not recommended and advised to register the product. |
8 |
06/06/2022 |
MD/815/06/2022 |
Dental Probes |
938 |
DHS/RS/RQ/108/20 date; 24/02/2021 |
Rivomed Holdings (pvt) ltd |
Snaa Industries - pakistan |
SPC Tender
|
Manufacturer registered with Indro (pvt) ltd. WOR Committee held on 11/06/2022 and committee decision was Not recommended and advised to register the product. Advised to NOL from Indro (Pvt) ltd. |
Not recommended and advised to register the product. |
20/08/2022 |
|||||||||||||
|
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value
|
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Approval |
||
01 |
12/07/2022 |
MD/904/07/2022 |
Cryo Sure - DMSO, Dimethyl Sulfoxide 10x10ml vials |
240 |
104994, date: 06/07/2022 |
EUR 2,232.00
|
Emar Pharma (Pvt) ltd |
WAK-Chemie Medical GmbH-Germany |
For National Blood Transfusion Service. |
Manufacturer is not registered under NMRA. |
Recommended only for this consignment. Advised to submit file. |
||
02 |
12/07/2022 |
MD/905/07/2022 |
Cold Disinfectant for Haemodialysis Machine |
50 |
777634582, date: 22/12/2021 |
EUR 480.50 |
Fresenius Medical Care |
Fresenius Medical Care - Germany |
For Lady Ridgway Hospital and Colombo East Base Hospital |
File Submitted for registration and sample not provided for evaluation by local agent. (D/899) |
Not recommended. Advised to provide samples to expedite registration. |
||
03 |
12/07/2022 |
MD/907/07/2022 |
Spare Parts for Patient Monitors and Defibrillators |
As per the invoice |
10027214, date: 29/06/2022 |
USD 24,883.50 |
Hemas Surgical & Diagnostics |
Nihon Kohden - Japan |
For Sri Jayewardenepura Hospital |
Agency transfer completed. But file not submitted by Hemas after agency transfer. |
Recommended only for this consignment. Will not consider for WOR again. Advised to submit the dossier for registration. |
||
04 |
12/07/2022 |
MD/908/07/2022 |
Spare Parts for Patient Monitors |
As per the invoice |
10027146, date: 29/06/2022 |
USD 3,017.48 |
Hemas Surgical & Diagnostics |
Nihon Kohden - Japan |
For District General Hospital - Trincomalee |
Agency transfer completed. But file not submitted by Hemas after agency transfer. |
Recommended only for this consignment. Advised to register the product for future importation. |
||
05 |
12/07/2022 |
MD/909/07/2022 |
Respiratory Pathogen Panel Kit V-1.0 |
03 |
SORD-072837, date: 09/06/2022 |
LKR 1,068,360.16 |
Analytical Instruments |
3B Black Bio Biotech Ltd - India |
KDU Purchase Order |
New Manufacturer. Manufacturer site is registered. (FMSA/MD/2021/85) But manufacturer name is different. Site is registered as Klipset India. |
Not recommended and advised to register the product. |
||
06 |
12/07/2022 |
MD/910/07/2022 |
HLA Reagents |
As per the Invoice |
7581939, date:16/06/2022 |
USD 125,586.07 |
Emar Pharma (Pvt) ltd |
One Lamda Inc – USA |
For National Blood Transfusion Service |
File already submitted for registration. (D/2731,D/3897) D/2731 – evaluation completed. D/3897- Under end user evaluation BB) |
Recommended only for this consignment. Expedite the registration. |
||
07 |
12/07/2022 |
MD/911/07/2022 |
Intravenous or Arterial tubing administration set. Closed System Transfer Set |
20 x 7 (140 Units) |
C3001, date:7/7/2022 |
USD 2,100.00 |
Apcot Marketing (Pvt) ltd |
BQ Plus Medical Co.ltd - China |
For National Blood Transfusion Service and Asiri Central Hospital. |
New Manufacturer. |
Recommended only for this consignment. Advised to submit file. |
||
08 |
15/07/2022 |
MD/912/07/2022 |
1)Epic Tissue Value(Brand : Epic, Model: E100 series) 2)Trifecta Tissue Value (Brand: Trifecta, Model: TFGT Series) 3)Value Graft Aortic Heart Value (Brand: SJM Masters Series, Model: CAVGJ Series) |
8
16
02 |
CGZ/SJM/CSD/002/2022 date: 23/06/2022, CGZ/SJM/CSD/003/2022 date: 23/06/2022 |
USD 58454.00 |
Ceegeez Associates |
M/s. St. Jude Medical – United States |
For urgent patient treatments in government and private sector hospitals. |
Already registered product and manufacturing site change. New manufacture in site registered on May 2022. (MD/160) |
Recommended only for this consignment. (New manufacturing site registration being proceed.) |
||
09 |
15/07/2022 |
MD/913/07/2022TENS |
TENS (Model: XY-K-SJD-A) (Muscular Stimulator) |
As per the invoice |
J20220222, date: 22/02/2022 |
USD |
Rajini Jayathilaka |
Xiangyu Medical Co.ltd - China |
For Personal Use. |
New Manufacturer. |
Recommended only for this consignment. |
||
10 |
19/07/2022 |
MD/916/07/2022 |
Dialysis Chairs |
02 |
493, date: 19/04/202 |
|
Synergy Life Solutions (Pvt) ltd |
Gardhen Bilance - Italy |
For Lady Ridgway Hospital for Children and Lanka Hospital PLC. |
· FR granted recently. (MDEC 3rd August 2022. (D/1699) |
Not recommended. Expedite the registration. |
||
11 |
22/07/2022 |
MD/919/07/2022 |
Hair PRP Kits |
400 |
N/A |
N/A |
Takara Entreprises |
Beijing Manson Technology Co.ltd |
For PRP Treatments. |
Not Manufacturer. |
Not recommended and advised to register the product. |
||
12 |
26/07/2022 |
MD/920/07/2022 |
Reagents for immunoassay/ Architect Analyzer |
As per the invoice |
ADD/PF/A523/2022/PAK/GMBH, date: 14/07/2022 |
US $ 9548.00 |
Hemas Surgical & Diagnostics |
Abbott GmbH - Germany |
To meet urgent demand due to manufacturing site change |
Already file submitted ( D/3476) and under processing. (P9) |
Not recommended. Expedite the registration. |
||
13 |
26/07/2022 |
MD/931/08/2022 |
A chromatographic immunoassay for the differential and qualitative detection of influenza virus A, B and A (H1N1) antigens directly from nasal/ throat/nasopharyngeal swabs or nasal/nasopharyngeal aspirate specimens. |
375 |
20026632 / 20026633 / 20026634 / 20026635 / 20026636
Date: 07/07/2022 |
USD 6750.00+6750.00+6750.00+6750.00+6750.00.. |
George Steuart Health (pvt) ltd |
Abbott Diagnostics Korea Inc - Korea |
To various hospitals. |
Manufacturer is registered with this local agent George Steuart for different products. |
Not recommended and advised to register the product. |
||
14 |
29/07/2022 |
MD/929/08/2022 |
Disinfection Cap (Stay Safe Disinfection Cap) |
520 |
PI4503108906,date: 01/06/2022 |
EUR 46.80 |
Fresenius Medical Care Lanka (Pvt) ltd |
Fresenius Medical Care AG & Co. KGaA - Germany |
For Several government and Private Hospitals. |
Registration Not recommended by Expert and requested Additional Documents. (D/2867) |
Not recommended and advised to register the product. Please follow the advice of the end user mentioned in the evaluation report. |
||
15 |
02/08/2022 |
MD/930/08/2022 |
1.Ortho Kit 2.Stethoscope 3.BP Monitors. (Brand:Omron, Elko) |
250 649 200 |
PI/2122/83 |
USD 5739.26 |
Hemas Pharmaceuticals (Pvt) ltd |
Omron Healthcare - Japan. |
For Promotional Purpose.
(Free of Charge.) |
New Manufacturer. Free of Charge Promotional Materials. |
Pending Decision. Advised to submit NO Objection Letter from registered agent. |
||
16 |
02/08/2022 |
MD/1005/08/2022 |
NovoSorb BTM – Dressing absorable |
45 |
N/A |
N/A |
Technomedics International (Pvt) ltd |
Polynovo Biomaterials pty ltd - Australia. |
Donation. Army hospital - Colombo and SBSCH - Peradeniya |
Manufacturing site change completed. And sample license process. |
Recommended only for this consignment. |
||
17 |
02/08/2022 |
MD/1005/08/2022 |
Biomedical Freezer |
1 |
HRP-004-Biomedica-2022, date: 27/7/2022 |
USD 3495.00 |
Biomedica (Pvt) ltd |
Haier Biomedical Co.ltd - China |
For University of Colombo. Research purpose. |
Grace period granted by MDEC until July 2023 for registration of freezers. |
Recommended only for this consignment. Advised to register as listed medical device. |
||
18 |
02/08/2022 |
MD/1007/08/2022 |
Thromboelastomy Reagents |
45+20 |
PORD-000728, 17/05/2022 |
Eur 22,338.05 |
Surgicare (Pvt) ltd |
TEM Innovations - Germany |
- |
Already registered product (D/888/RR) D/538) German origin product registered. Manufacturing site changed to Denmark – Finland) |
Recommended only for this consignment. |
||
19 |
08/08/2022 |
MD/1015/08/2022 |
Infusion Syringe Pump Including Software and Standard Accessories and Spare Parts |
02 |
BBLK/INV/002/2022, date: 27/07/2022 |
EUR 2,193.22 |
B. Braun Lanka (Pvt) ltd |
B. Braun Melsungen AG - Germany |
Lanka Hospitals Purchase Order |
Already registered product (DVR 882 RR). MF site changed and Submitted application and under processing D/4160 |
Not recommended. Expedite the registration. |
||
20 |
08/08/2022 |
MD/1016/08/2022 |
I.V. Administration Sets for chemotherapy. |
2000 |
BBLK/INV/001/2022, date: 22/07/2022 |
EUR 5640.00 |
B. Braun Lanka (Pvt) ltd |
B. Braun Melsungen AG - Germany |
For Chemotherapy receiving pa tient. |
Manufacturer registered with B Braun Lanka. Not a registered product. |
Recommended only for this consignment. Advised to submit registration dossier. |
||
21 |
10/08/2022 |
MD/1017/08/2022 |
Plaster of Paris Bandage BP |
50,000 rolls and 8,000 rolls |
N/A |
N/A |
Swedish Trading Company (Pvt) ltd |
Cotton Craft (Pvt) ltd - Pakistan |
For Health System Enhancement Project, Ministry of Health. |
Full registration expired on 2019. Not the apply for re registration. Sample license applied recently to submit new file. |
Recommended only for this consignment. Expedite the registration. |
||
22 |
10/08/2022 |
MD/1018/08/2022 |
Paraffin Gauze Dressing BP |
35,000 rolls |
N/A |
N/A |
Swedish Trading Company (Pvt) ltd |
Cotton Craft (Pvt) ltd - Pakistan |
For Health System Enhancement Project, Ministry of Health. |
Registration expired on 2014. (DVR3701) Sample licenses applied. |
Recommended only for this consignment. |
||
23 |
10/08/2022 |
MD/1019/08/2022 |
Absorbent Cotton Wool BP |
350,000 rolls |
N/A |
N/A |
Swedish Trading Company (Pvt) ltd |
Cotton Craft (Pvt) ltd - Pakistan |
For Health System Enhancement Project, Ministry of Health. |
FR expired on 2022. (DVR12699) |
Recommended only for this consignment. Expedite the registration. |
||
24 |
10/08/2022 |
MD/1020/08/2022 |
Absorbent Cotton Wool BP |
15,000 rolls |
N/A |
N/A |
Swedish Trading Company (Pvt) ltd |
Cotton Craft (Pvt) ltd - Pakistan |
For Health System Enhancement Project, Ministry of Health. |
FR expired on 2022. (DVR12699) |
Recommended only for this consignment. Expedite the registration. |
||
25 |
10/08/2022 |
MD/1021/08/2022 |
Absorbent Cotton Wool BP |
100,000 rolls |
N/A |
N/A |
Swedish Trading Company (Pvt) ltd |
Cotton Craft (Pvt) ltd - Pakistan |
For Health System Enhancement Project, Ministry of Health. |
FR expired on 2022. (DVR12699) |
Recommended only for this consignment. Expedite the registration. |
||
26 |
16/08/2022 |
MD/1030/08/2022 |
1. Blood Grouping Anti - A
|
|
2113272, date: 03/01/2022 |
58,950.7 2 |
Transmed Internatio nal (Pvt) ltd
|
Diagast - France |
For National Transport Medical Institute. |
1. Registered product and registration expired in 2021. (File : DVR 13583) Local agent not applied to extend the registration. |
Not recommended and advised to register the product. |
||
2. Blood Grouping Anti – B
|
|
Same as above |
Same as above |
Same as above |
Same as above |
Same as above |
2. Registered product and registration expired in 2021. (File : DVR 139223) Local agent not applied to extend the registration. |
||||||
3. Blood Grouping Anti - D |
|
Same as above |
Same as above |
Same as above |
Same as above |
Same as above |
3. Registered product and registration expired in 2021. (File : DVR 13922) Local agent not applied to extend the registration. |
||||||
27 |
16/08/2022 |
MD/1031/08/2022 |
Consumables for Stem Cell Harvesting Kits |
380 |
TSL/SL/22/08/01, date: 5/8/2022 |
Euro 13,300.00 |
Apcot Marketing (Pvt) ltd |
Maco Pharma Rue Lortgiois - France. |
For National Blood Transfusion Service and Asiri Central Hospital. |
Manufacturer already registered with NMRA. |
Recommended only for this consignment. Advised to submit file for registration. |
||
28 |
16/08/2022 |
MD/1032/08/2022 |
Disinfectant for Instruments and endoscopes. (brand: Getinge) (Universal Detergent 1x5L , Rinse Aid 1x5L) |
200+60 |
8085412095, date: 25/07/2022 |
USD 11,620.00 |
Mediquipment Limited |
Getting Disinfection AB - Sweden |
For Central Hospital Limited and Hemas Thalawathugoda. |
Manufacturer registered with NMRA. |
Recommended only for this consignment. Advised to submit dossier for registration. |
||
29 |
18/08/2022 |
MD/1033/08/2022 |
Reagents for Architect Clinical Chemistry Analyzer (Analyze(Brand: Abbott) |
As per the invoice |
5500014485 date: 28/07/2022 |
USD 34,376.00 |
Hemas Surgical and Diagnostics (Pvt) ltd |
Abbott Laboratories - USA |
For National Hospital of Sri Lanka. |
Already registered (DVR 16055) and manufacturing site change. New file submitted and under processing. (File:D/4126) |
Not recommended. Expedite the registration. |
||
30 |
22/06/2022 |
MD/844/06/2022 |
Air Mettress (Brand: Fitconn, Model: FU-AM001) |
2700 |
P22309JN151, date: 09/03/2022 |
US $ 38,905.00 |
Medica Pharmaceuticals (Pvt) ltd |
Shenzhen Fitvonn Technology Co.ltd - China |
to cover the shortage in Sri Lanka Market |
Appeal. Manufacture is not registered with NMRA. Registered sources available. WOR Committee held on 13/07/2022 and committee decision was Not recommended and advised to register the product. |
Not recommended and advised to register the product. |
||
31 |
22/06/2022 |
MD/845/06/2022 |
Wheelchairs |
328 |
HBDS2204297152, date: 2022/04/29 |
USD 16252.00 |
Medica Pharmaceuticals (Pvt) ltd |
Hebei Dansong Medical Equipment Co.ltd - China |
to cover the shortage in Sri Lanka Market |
Appeal. Manufacture is not registered with NMRA. Registered sources available. WOR Committee held on 13/07/2022 and committee decision was Not recommended and advised to register the product. |
Not recommended and advised to register the product. |
||
32 |
9/9/2021 |
MD/07/09/2021 |
Oxygen Production Plant, Generator (Oxymat - Slovakia) |
1 |
Tender Number:UNOPS-22900-EPP-030R, date:02/09/2021 |
USD 1,570,000.00 |
Delmege Forsyth & Co.ltd |
Process Engineering S.r.l - Milano |
UNOPS Tender.
|
WOR Committee held on 13/07/2022 and committee decision was Pending Decision. Advised to send a letter Director (Building), Ministry of Health for evaluate the product. |
Pending Decision. Referred to College of Anesthesiology. |
||
33 |
25/04/2022 |
MD/748/04/2022 |
Oxygen Generator Plant |
2 |
N/A |
N/A |
Delmege Forsyth& Co.ltd |
Meditech TechnologyCorp.ltd-China |
Ministry of Health Tender |
Manufacturer not registered under NMRA. WOR Committee held on 07/05/2022 and committee decision was Currently NMRA not regulating Oxygen Generator Plant. If tender is awarded after BMES evaluation to issue NOL. |
Pending Decision. Referred to College of Anesthesiology. |
||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
Previous WOR Committee Decision |
WOR Committee Approval |
|
34 |
15/06/2022 |
MD/831/06/2022 |
1. Main Stretcher
2. Foldaway Stretcher(for ford ambulances)
|
62
62 |
|
|
Future Automobiles (Pvt) ltd |
Jiangsu Rixin Medical Equipment co.ltd - China
|
For Ministry of Health (Not a Donation) |
Manufacturer is registered under NMRA with Local Agent "Access international". (No current valid registrations for the product.) ISO, EC certificates and registration document of US FDA are submitted. |
WOR Committee held on 13/07/2022 and committee decision was Not recommended. Need a recommendation from college of anesthesiology. Advised to arrange an inspection with college members of Anesthesiology. |
Recommended only for this consignment.
|
|
Same as above |
Same as above |
3. Portable Oxygen Therapy Kit |
62 |
|
|
Same as above |
Medbirlesim - Turkey |
For Ministry of Health (Not a Donation) |
Manufacturer not registered ISO, EC certificates are submitted. |
||||
Same as above |
Same as above |
4. First Aid Bag (for ford ambulances) |
62 |
|
|
Same as above |
Medbirlesim - Turkey |
For Ministry of Health (Not a Donation) |
Manufacturer not registered ISO, EC certificates are submitted. |
||||
35 |
17/09/2021 |
MD/100/09/2021 |
Fingertip Pulse oximeter |
100 |
1Z5582W46790642971 |
USD 340.00 |
N.P. Charith Chanuka Nugawela. |
Dongguan Bucks Medical technology Co.ltd - China |
|
BMES not recommended. Report of pending from anesthesiology |
New Manufacturer. |
Not recommended and advised to register the product. |
|
20/08/2022 - S.P.C |
|||||||||||||||
|
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Approval |
||||
01 |
15/07/2022 |
MD/914/07/2022 |
Central Venous Catheter Set, Double Lumen and Triple Lumen |
As per the invoice |
DHS/ICL/X/RS/026/2022 date:31/03/2022 |
USD 68,006.00 |
Nextgen Healthcare |
La-Med Healthcare (Pvt) ltd - India |
SPC Tender |
Manufacturer Registered with NMRA. Single Luman Catheter rejected by expert. (DVR/16986). Double Luman Catheter registration expired in 2019. (DVR/17287) |
Not recommended. SPC informed enough stock is available. |
||||
02 |
19/07/2022 |
MD/915/07/2022 |
Extension Plaster BP |
As per the invoice |
DHS/ICL/X/RS/037/116AM/2022, date:13/06/2022 |
US $ 23,400.00
|
Intermediq Holdings (Pvt) ltd |
Dr. Sabhanwals Wound Care - India |
SPC Tender |
Product was registered with Geekay and expired on 2016. (DVR/16070) |
Recommended with Condition. Subject to submit of NOL from previous local agent, Geekay. |
||||
03 |
19/07/2022 |
MD/917/07/2022 |
Non Absorbable Monofilament Surgical Suture |
21000 |
DHS/ICL/X/RS/013/128RA/22, date:28/06/2022 |
US $ 83,160.00
|
Synerg0.y Life Solutions (Pvt) ltd |
Healthium Meditech Limited - India |
SPC Tender |
FR granted on November 2021 |
Recommended only for this consignment. |
||||
04 |
22/07/2022 |
MD/918/07/2022 |
Disposable Intravenous Solution Giving Sets for Single Use |
900000 |
DHS/PS/171/2022 date:05/07/2022 |
US $ 95,400.00 |
Medica Pharmaceuticals |
Hi-Tech Medics (Pvt) ltd - India |
SPC Tender |
Manufacturer earlier appointed shield Medical and manufacturing site still not registered with NMRA. Recently agency transfer is under processing from Shield medical to this Local agent. |
Hold till SPC submit tender documents. |
||||
05 |
04/08/2022 |
MD/1004/08/2022 |
HBsAg Rapid Test (Brand: OnSite) |
160 packs |
LP/DHS/RL/18/33WAC/22, date:26/07/2022 |
LKR. 560,000/- |
Quick Medical Diagnostics (Pvt) ltd |
CTK Biotech Inc - USA |
SPC Tender |
FR granted recently (D/1314) Sub EMDEC 19/08/2022. |
Not recommended. Expedite the registration. |
||||
06 |
08/08/2022 |
MD/1022/08/2022 |
Micro Motor System with Hand priece, Accessories, Spare Parts |
7 |
LP/DHS/SUS/WW/187/403DS/21, date: 03/11/2021 |
LKR 35,700,000.00 |
A. Baur & Co. (Pvt) ltd |
Medtronic Xomed Inc - USA. |
SPC Tender |
Already registered product (DVR 14474). Same legal manufacturer and Manufacturing site changed. File still not submitted. |
Recommended only for this consignment. |
||||
07 |
16/08/2022 |
MD/1034/08/2022 |
Urine Collecting Bag -2000ml (Brand: Romsons) |
35,000 + 500,000 |
DHS/S/WW/38/84KC/2021, date: 28/12/2020 , DHS/S/WW/38/434KC/2021, date: 3/8/21 |
USD 205,625.00+117,500.00 |
Lanka Laboratories (Pvt) ltd |
M/s. Romsons International - India |
SPC Tender |
Already file submitted for submission. (D/3906) Awaiting evaluation by expert. |
Recommended only for this consignment. |
||||
08 |
18/08/2022 |
MD/1035/08/2022 |
Temporary Anchorage Screw |
2460 |
DHS/SUS/WW/181/553DR/2021, date:16/06/2022 |
USD 22,939.10 |
Med Solutions (Pvt) ltd |
Osteonic Co.ltd - Korea |
SPC Tender |
Legal manufacturer registered with NMRA. In 2014 submitted file was referred to DDG Dental Service, Ministry of Health. Sent reminder but file not returned. (DVR-15150) |
Not recommended. Considering the critical nature of the product, request to submit a new file. |
||||
08/10/2022 |
||||||||||||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Approval |
|||||||||
01 |
22/08/2022 |
MD/1051/09/2022 |
Surgical Kit |
24 |
N/A |
N/A |
Oram (Pvt) ltd |
M/s. Kamal Encon Industries Ltd - India |
Usage of low income university student's practical sessions. |
Manufacturer is not registered. |
Not recommended and advised to register the product. |
|||||||||
02 |
29/08/2022 |
MD/1055/09/2022 |
Vacum off pump system for cardiac surgical procedures (Brand: Acrobat-OM Series) |
25 |
SEA-ACT-2022-002, |
USD 25,000.00 |
Ceegeez Associates |
Getinge AB - Sweden |
For urgent patient treatments in government and private sector hospitals. |
Registered product of manufacturer with ceegeez. (Ref No: DVR-11592) |
Not recommended. Expedite the registration. |
|||||||||
03 |
29/08/2022 |
MD/1056/09/2022 |
Reagents for Hematology Analyzer |
1170 EA |
10030052, date: 23/08/2022 |
USD 35,900.50 |
Hemas Surgical & Diagnostics |
Nihon Kohden - Japan |
For Sri Lanka Air Force |
Manufacturer registered with Hemas Surgicals (Only for defibrillator) |
Recommended only for this consignment. Advised to Expedite the registration process. |
|||||||||
04 |
07/09/2022 |
MD/1062/09/2022 |
Dental Extraction Elevators |
1 |
S20220608, date:08/09/2022 (DE 532) |
USD$ 55.90 |
Dr. Neil Hemantha Karandeniya |
SCS Medical Instrument Ltd - China |
For Surgery. |
Not registered Manufacturer. |
Pending Decision. Advised to submit letters from Local Suppliers indicating that this equipment cannot be supplied. |
|||||||||
05 |
07/09/2022 |
MD/1063/09/2022 |
Autoclave Sterilizer |
1 |
S20220608, date:08/09/2022 |
USD$ 480.00 |
Dr. Neil Hemantha Karandeniya |
SCS Medical Instrument Ltd - China |
For Surgery. |
Not registered Manufacturer. |
Pending Decision. Advised to submit letters from Local Suppliers indicating that this equipment cannot be supplied. |
|||||||||
06 |
07/09/2022 |
MD/1064/09/2022 |
Complete Dental Chair and Unit + Air Compressure |
2 |
S20220608, date:08/09/2022 |
USD$ 4,730.00 |
Dr. Neil Hemantha Karandeniya |
SCS Medical Instrument Ltd - China |
For Surgery. |
Not registered Manufacturer. |
Pending Decision. Advised to submit letters from Local Suppliers indicating that this equipment cannot be supplied. |
|||||||||
07 |
07/09/2022 |
MD/1065/09/2022 |
Physio Dispensor |
1 |
S20220608, date:08/09/2022 (C-SAILOR) |
USD $ 1,700.00 |
Dr. Neil Hemantha Karandeniya |
SCS Medical Instrument Ltd - China |
For Surgery. |
Not registered Manufacturer. |
Pending Decision. Advised to submit letters from Local Suppliers indicating that this equipment cannot be supplied. |
|||||||||
08 |
07/09/2022 |
MD/1066/09/2022 |
Dental Light Luring Metchine |
1 |
S20220608, date:08/09/2022 (LED-B) |
USD$ 53.00 |
Dr. Neil Hemantha Karandeniya |
SCS Medical Instrument Ltd - China |
For Surgery. |
Not registered Manufacturer. |
Pending Decision. Advised to submit letters from Local Suppliers indicating that this equipment cannot be supplied. |
|||||||||
09 |
07/09/2022 |
MD/1067/09/2022 |
SCS Extraction Forceps |
1 |
S20220608, date:08/09/2022 (DE-255) |
USD $ 50.00 |
Dr. Neil Hemantha Karandeniya |
SCS Medical Instrument Ltd - China |
For Surgery. |
Not registered Manufacturer. |
Pending Decision. Advised to submit letters from Local Suppliers indicating that this equipment cannot be supplied. |
|||||||||
10 |
07/09/2022 |
MD/1068/09/2022 |
Dental Extraction Froceps |
1 |
S20220608, date:08/09/2022 (DE-256) |
USD $ 80.00 |
Dr. Neil Hemantha Karandeniya |
SCS Medical Instrument Ltd - China |
For Surgery. |
Not registered Manufacturer. |
Pending Decision. Advised to submit letters from Local Suppliers indicating that this equipment cannot be supplied. |
|||||||||
11 |
07/09/2022 |
MD/1069/09/2022 |
Dental Extraction Froceps |
1 |
S20220608, date:08/09/2022 (DE-254) |
USD $ 75.00 |
Dr. Neil Hemantha Karandeniya |
SCS Medical Instrument Ltd - China |
For Surgery. |
Not registered Manufacturer. |
Pending Decision. Advised to submit letters from Local Suppliers indicating that this equipment cannot be supplied. |
|||||||||
12 |
07/09/2022 |
MD/1070/09/2022 |
Dental Extraction Froceps |
1 |
S20220608, date:08/09/2022 (DE-253 |
USD $ 97.50 |
Dr. Neil Hemantha Karandeniya |
SCS Medical Instrument Ltd - China |
For Surgery. |
Not registered Manufacturer. |
Pending Decision. Advised to submit letters from Local Suppliers indicating that this equipment cannot be supplied. |
|||||||||
13 |
07/09/2022 |
MD/1071/09/2022 |
PCS CRP rapid test kit, PCS FTN test Kits, PCS CTN test kits, PCS CRP test detection buffer |
8+2+3+8 |
N/A |
N/A |
A.A. Jeyapragasam |
M/s. Guangzhou Wondfo Biotech Co.ltd - China |
For Abishaa Hospital (Pvt) ltd - Vavuniya |
Manufacturer is registered under NMRA with, Lifeserv – HCG Strips. - PC Pharma - Syphilis test. - Sri Chin Holdings – HCG Strip. |
Not recommended and advised to register the product. |
|||||||||
14 |
02/09/2022 |
MD/1073/09/2022 |
Spare Parts for Video Endoscopy System |
As per the invoice |
PMSSPI0000000018859, date: 19/08/2022 |
USD 17,487.74 |
Biomed International (Pvt) ltd |
Hoya Corporation - Japan |
For Teaching Hospital - Anuradhapura, Base Hospital - Elpitiya, Teaching Hospital - Kuliyapitiya, Office of Regional Director of Health Services - Puttalam, Base Hospital - Homagama, District General Hospital - Hambantota, Hemas Hospital (Pvt) ltd |
Registered Product. (Ref: D-980-RR) |
Recommended only for this consignment. |
|||||||||
15 |
09/09/2022 |
MD/1091/09/2022 |
Training Unit (TRN 3100), AED Unit and Spare Parts |
1 x 4 |
10030343, date:05/09/2022 |
USD 1,727.00 |
Hemas Surgical & Duagnostics |
Nihon Kohden - Japan |
Donation to College of Anesthesiologists and Intensivists of Sri Lanka |
Manufacturer registered with Hemas Only for this defibrillator. |
Recommended only for this consignment. |
|||||||||
16 |
09/09/2022 |
MD/1090/09/2022 |
10ml Syringe, 20ml Syringe and 60ml Syringe (Brand: Terumo) |
30,000 |
PFI-22/009, date: 06/09/2022 |
USD 920.00 |
Hemas Surgical & Duagnostics |
Yaoungzhou Medline Industry Co.ltd - China. |
Donation to Sri Lanka College of Pediatricians |
Yaoungzhou Medline Industry Co.ltd - China is not registered. |
Recommended only for this consignment. |
|||||||||
17 |
09/09/2022 |
MD/1093/09/2022 |
College of American Pathologist (CAP) Proiciency Testing Program |
As per the invoice |
384838 date: 31/07/2022 |
$83,727.00 |
Lanka Hospital Diagnostics (Pvt) ltd |
College of American Pathologist - United Status of America |
For External Quality Assurance Programme of the Lab. |
Not a registered manufacturer. |
Recommended only for this consignment. |
|||||||||
18 |
16/09/2022 |
MD/1094/09/2022 |
Wallace Catheters & Oocyte recovery system (IUI Catheters, Surview Embray Replacement Catheter, Stylet, Oocyte recovery system) |
400 |
OIPL/21-22/PI/AB/001, date: 22/08/2022 |
$41,966.30 |
A. Baur & Co. (Pvt) ltd |
Cooper Surgical Inc - USA |
For several Hospitals. (Lanka Hospital PLC, Nawaloka Hospital PLC, Vindana Reproductive Health Centre, Suwika Fertility Center, Ninewells Hospital & Asiri Hospitals) |
Manufacturer is registered with Kanmed & Technomedics for different product. (Ref: DVR-10232/DVR-16435 /DVR-16804/ DVR-10233/DVR-10234. New site to be registered. |
Recommended only for this consignment. |
|||||||||
19 |
16/09/2022 |
MD/1102/09/2022 |
Sterilizer System and standard accessories and spare parts (Brand:Getinge, Model:Solsus 66) |
As per the invoice |
8085412108, date: 29/07/2022 |
USD 101,431.00 |
Mediquipment Limited |
MAQUET GmbH - Germany |
For Leesons Hospital - Ragama. |
Manufacturer registered with Technomedics & Swiss biogenics for different product. |
Not recommended and advised to register the product. |
|||||||||
20 |
16/09/2022 |
MD/1103/09/2022 |
Fetal/Maternal Monitoring Solution (CTG Machine) with Standard Accessories, Consumables and Spare parts (Brand: Toitu, Model: MT - 516) |
As per the invoice |
220905-10, date: 05/09/2022 |
Yen 1,095,000.00 |
Mediquipment Limited |
Toitu Co.ltd - Japan |
For Base Hospital - Elpitiya and B.H. Dehiaththakandiya. |
Registered Product. (Ref:DVR-13556) |
Recommended only for this consignment. |
|||||||||
21 |
16/09/2022 |
MD/1104/09/2022 |
Sterilizer System and standard accessories and spare parts (Brand:Getinge, Model:HS66, HC) |
As per the invoice |
8085412258, date: 28/08/2022 |
USD 21,031.18 |
Mediquipment Limited |
Getinge AB - Sweden |
For Several Government and privet sector hospitals) |
Registered manufacturer with Mediquipment Limited. (Ref: DVR-13130) |
Recommended only for this consignment. |
|||||||||
22 |
16/09/2022 |
MD/1106/09/2022 |
Upper Arm Electronic Blood Pressure Moitor (Brand:MG, Model: U80EH) |
5000 Pack |
CMS221024-1, date:24/07/2022 |
Euro 12,500.00 |
MG Medicals (Pvt) ltd |
Shenzen Urion Technology Co.ltd - China |
For Government Hospitals |
Not a registered manufacturer under NMRA. |
Not recommended. Expedite the registration. |
|||||||||
23 |
12/09/2022 |
MD/1107/09/2022 |
Microscope (Brand: Xeiss, Model: Vario 700) |
1 |
44113584, date: 19/07/2022 |
Euro 2,700.00 |
Qveensbury Hospitals (Pvt) ltd |
Carl Zeiss AG - Germany |
For Teaching Purpose |
Manufacturer is registered with Dimo (Pvt) ltd |
Pending Decision. Advised to submit the Private Health Services Regulatory Council Registration Certificate and Evidence of Teaching activities related to this field of medical device. |
|||||||||
24 |
15/09/2022 |
MD/1109/09/2022 |
Artificial Limbs |
N/A |
N/A |
N/A |
Matammana Orthopedic Suppliers Company (Pvt) lyd |
N/A |
? |
No manufacturer details. |
Product Categorization. |
|||||||||
25 |
20/09/2022 |
MD/1111/09/2022 |
Infusion Pump Including Software and Standard Accessories and Spare Parts. (Brand: Infusion Space P, Volumetric) |
1 |
1809703503, date: 09/09/2022 |
Eur 639.22 |
B. Braun Lanka (Pvt) ltd |
B. Braun Melsungen AG - Germany |
Already a registered product. |
Recommended only for this consignment. Advised to apply for registration. |
||||||||||
26 |
02/09/2022 |
MD/1074/09/2022 |
Thermal Cycler - PCR (Brand: Thermo Fisher, Model: Miniamp Plus, Simpliamp, Hula Sample Mixture) |
As per the invoice |
73895636 SO, date : 11.2.2022 / 73897700 SO, date: 22.02.2022 / 73900143 SO, date: 04/03/2022 |
USD 2,100.00 + USD 4,700.00 + USD 4,684.00 |
Analytical Instruments (Pvt) ltd |
Thermo Fisher - USA |
For research and Development Use only. (Several Government Istitute) |
Thermo Fisher Scientific – USA registered with Delmege forsyth & Co.ltd. |
Pending Decision. Advised to submit Ethic Committee Approval Letters for the research of mentioned all the institutions. |
|||||||||
27 |
2209/2022 |
MD/1117/09/2022 |
Sterilizer Stem and Spare parts, standard accessories (Getinge Steam Sterilizer) |
4 |
8085412348, date: 14/09/2022 |
USD 541.36 |
Mediquipment Limited |
Getinge Sourcing LLC - Singapore. |
For UHKDU and Dr. Neville Fernando Teaching Hospital |
Registered manufacturer with Mediquipment for "Getinge" Sterilizer. (Ref:DVR-13784) |
Recommended only for this consignment. |
|||||||||
28 |
20/09/2022 |
MD/1110/09/2022 |
Socket Adapters For P&O Workshop |
As per the invoice |
22-2101939, date: 02/06/2022 |
Euro 22,961.60 |
Ministry of Defence (Local Agent: M/s. Vertrin International |
M/s. Wagner Polymertechick GmbH - germany |
For Sri Lanka Army. (Not a Donation) |
Not a registered Manufacturer. |
Product Categorization. |
|||||||||
29 |
23/09/2022 |
MD/1127/10/2022 |
Powder for production of liquid bicarbonate concentrate for bicarbonate heamodialysis |
20,000 PCE |
4503184353 date: 20/09/2022 |
Eur 16,600.00 |
Fresenius Medical Care Lanka (Pvt) ltd |
Fresenius Medical Care AG & Co. KGaA - Germany |
For patient with chronic kindly disease. |
Registered manufacturer under NNRA. Previously registered product as a medicine. (Ref: D/4178) |
Not recommended. Expedite the registration. |
|||||||||
30 |
05/10/2022 |
MD/1130/10/2022 |
Ultrasound Gastro Videoscope (Model: GF-UCT180) |
1 |
N/A |
N/A |
Technomedics International (Pvt) ltd |
Shirakawa Olympus Co.ltd - Japan |
shop of the Sri Lanka Society of Gastroenterology. |
Manufacturer site is registered with Mediquipment & Access International. (Ref: DVR-14601) |
Recommended only for this consignment with condition. (Should be re-exported after the workshop)
|
|||||||||
31 |
05/10/2022 |
MD/1132/10/2022 |
HbAIC Rapid Quantitative test (Brand: Finecare) |
As per the invoice |
DC/4633/22-23, date: 17/09/2022 |
INR 20,000.00 |
Shahul Hameedas Avdul Malik |
Guangzhou Wondfo Biotech Co.ltd - China |
For Laboratory use. |
Manufacturer exists in the database with a different site address. With Lifeserv(Pvt) ltd, PC Pharma (pvt) ltd, Sri Chin Holdings. (Ref:DVR-3831) |
Not recommended and advised to re-export. |
|||||||||
32 |
05/07/2022 |
Research Instruments Parts |
As per the invoice |
3977184, date: 03/06/2022 |
USD 3,331.73 |
Prof. Prasanna Galhena, Director, Institue of Biochemistry, Molecular Biology and Biotechnology, University of Colombo |
Agilent Technologies - Singapore |
For Research and Development Purpose. |
Donation. WOR Committee held on 13/07/2022 and committee decision was Recommended with condition. Subject to submission of Ethic Committee Clearance Letter. |
Recommended only for this consignment. |
||||||||||
33 |
26/07/2022 |
MD/920/07/2022 |
Reagents for immunoassay/ Architect Analyzer |
As per the invoice |
ADD/PF/A523/2022/PAK/GMBH, date: 14/07/2022 |
US $ 9548.00 |
Hemas Surgical & Diagnostics |
Abbott GmbH - Germany |
To meet urgent demand due to manufacturing site change |
Already file submitted (D/3476) and under processing. (P9) WOR Committee held on 20/08/2022 and committee decision was Not recommended. Expedite the registration. |
Recommended only for this consignment. |
|||||||||
34 |
18/08/2022 |
MD/1033/08/2022 |
Reagents for Architect Clinical Chemistry Analyzer (Analyze(Brand: Abbott) |
As per the invoice |
5500014485 date: 28/07/2022 |
USD 34,376.00 |
Hemas Surgical and Diagnostics (Pvt) ltd |
Abbott Laboratories - USA |
For National Hospital of Sri Lanka. |
Already registered (DVR 16055) and manufacturing site change. New file submitted and under processing. (File:D/4126) WOR Committee held on 20/08/2022 and committee decision was Not recommended. Expedite the registration. |
Recommended only for this consignment. |
|||||||||
35 |
26/07/2022 |
MD/931/08/2022 |
A chromatographic immunoassay for the differential and qualitative detection of influenza virus A, B and A (H1N1) antigens directly from nasal/ throat/nasopharyngeal swabs or nasal/nasopharyngeal aspirate specimens. |
375 |
20026632 / 20026633 / 20026634 / 20026635 / 20026636
Date: 07/07/2022 |
USD 6750.00+6750.00+6750.00+6750.00+6750.00.. |
George Steuart Health (pvt) ltd |
Abbott Diagnostics Korea Inc - Korea |
To various hospitals. |
Manufacturer is registered with this local agent George Steuart for different products. WOR Committee held on 20/08/2022 and committee decision was Not recommended and advised to register the product. |
Not recommended. Expedite the registration. |
|||||||||
36 |
12/07/2022 |
MD/909/07/2022 |
Respiratory Pathogen Panel Kit V-1.0 |
03 |
SORD-072837, date: 09/06/2022 |
LKR 1,068,360.16 |
Analytical Instruments |
3B Black Bio Biotech Ltd - India |
KDU Purchase Order |
New Manufacturer. Manufacturer site is registered. (FMSA/MD/2021/85) But manufacturer name is different. Site is registered as Klipset India. WOR Committee held on 20/08/2022 and committee decision was Not recommended and advised to register the product. |
Not recommended. Expedite the registration. |
|||||||||
37 |
16/08/2022 |
MD/1030/08/2022 |
1. Blood Grouping Anti - A
|
72 |
2113272, date: 03/01/2022 |
58,950.7 2 |
Transmed Internatio nal (Pvt) ltd
|
Diagast - France |
For National Transport Medical Institute. |
Registered product and registration expired in 2021. (File : DVR 13583) Local agent not applied to extend the registration. |
WOR Committee held on 20/08/2022 and committee decision was Not recommended and advised to register the product. |
Recommended only for this consignment. Expedite the registration. |
||||||||
|
|
2. Blood Grouping Anti – B
|
72 |
Same as above |
Same as above |
Same as above |
Same as above |
Same as above |
Registered product and registration expired in 2021. (File : DVR 139223) Local agent not applied to extend the registration. |
|||||||||||
|
|
3. Blood Grouping Anti - D |
1440 |
Same as above |
Same as above |
Same as above |
Same as above |
Same as above |
Registered product and registration expired in 2021. (File : DVR 13922) Local agent not applied to extend the registration. |
|||||||||||
38 |
23/02/2022 |
MD/625/02/2022 |
Table Mounted Retractor |
1 |
|
|
Gilead Innovations |
Mediflex Surgical Products - USA |
For National Hospital - Sri Lanka |
Appeal. Ongoing Agency Transfer to Gilead, September 2022. (LO/1280) Submitted to WOR Committee held on 12/03/2022 and committee decision was Not recommended and advised to register the product. WOR Committee held on 09/04/2022 and committee decision was Not recommended and advised to register the product. |
Not recommended and advised to register the product. |
08/10/2022 - S.P.C |
||||||||||||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Approval |
|||||||||
01 |
29/08/2022 |
MD/1057/09/2022 |
Immunohistochemistry Reagents |
519 |
DHS/L/WW/81/014RS/22 |
US$ 16,555.40 |
A & M Suhada Enterprises (Pvt) ltd |
Agilent Technologies Singapore - Singapore / Agilent Technologies Inc - US |
SPC Order |
Manufacturer not registered under NMRA. |
Not recommended. Expedite the registration. |
|||||||||
02 |
29/08/2022 |
MD/1054/09/2022 |
Praffin Gauze Dressing BP |
34,000 Rolls |
DHS/S/WW/86/22, date:31/08/2021 |
USD 54,060.00 |
Swedish Trading Company (Pvt) ltd |
Cotton Craft (Pvt) ltd - Pakistan |
SPC Order |
Manufacturer registered with this local agent under NMRA. |
Not recommended and advised to register the product. |
|||||||||
03 |
23/09/2022 |
MD/1128/10/2022 |
One step test for dengue NS 1Ag Kit |
10,000 packs |
DHS/ICL/X/RL/027/22, date: 07/07/2022 |
US$ 358,000.00 |
Siba Holdings (Pvt) ltd |
Meril Diagnostics (Pvt) ltd - India |
SPC Order |
Registered Product. (Ref: Nu: D-1085) Expired on 01/08/2020. |
Not recommended. Advice to procure from registered source. |
|||||||||
04 |
06/10/2022 |
MD/1135/10/2022 |
Leads & Sheath |
900 NOS |
DHS/M/SS/WW/4/565DP/2021, date: 12/07/2022 |
US $ 562,500.00 |
Medrac (pvt) ltd |
Medtronic International Limited - Singapore |
SPC Order |
Registered manufacturer site with Medtrac (Pvt) ltd. (SIL 4785/01/2022) |
Pending Decision. Advised to request the registration certificate include the accessories. |
|||||||||
05 |
06/10/2022 |
MD/1136/10/2022 |
Leads & Sheath |
600 NOS |
DHS/M/SS/WW/5/573DP/2021, date: 20/07/2022 |
US $ 720,000.00 |
Medrac (Pvt) ltd |
Medtronic International Limited - Singapore |
SPC Order |
Registered with Medtrac (Pvt) ltd for "Vitatron MRI Surescan" single chamber pacemaker. (Ref:D-3388) (SIL under processing) |
Pending Decision. Advised to request the registration certificate include the accessories. |
|||||||||
19/11/2022 |
|||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Approval |
01 |
12/10/2022 |
MD/1164/10/2022 |
Surgical Suture (Brand:Haidike, Model: PGA,PGLA, PDO, NYLON, SILK, POLYSTER, POLYPROPHYLENE |
792 |
221002SLS, date: 2/10/2022 |
$369.96 |
Rashi International Import Export (Pvt) ltd |
Shandong Haidike Medical Products Co.ltd - China |
Reason not mentioned. |
Manufacturer not registered. Registered sources available. |
Not recommended and advised to register the product. |
02 |
12/10/2022 |
MD/1163/10/2022 |
Dental Chairs (Brand: Haiyue, Model: HY-803, HY-806, HY-C9A, HY-E60) |
N/A |
N/A |
N/A |
Rashi International Import Export (Pvt) ltd |
Foshan Haiyue (HIROL) Medical Equipment Co.ltd - China |
Reason not mentioned. |
Manufacturer not registered. Registered sources available. |
Not recommended and advised to register the product. |
03 |
12/10/2022 |
MD/1162/10/2022 |
Curing Light Machine (Brand: Jerry, Model: JR-CL17, JR-CL37) |
10 |
JR-A220928, date: 28/09/2022 |
$479.00 |
Rashi International Import Export (Pvt) ltd |
Foshan Jerry Medical Apparatus Co.ltd - China |
Reason not mentioned. |
Manufacturer not registered. Registered sources available. |
Not recommended and advised to register the product. |
04 |
12/10/2022 |
MD/1161/10/2022 |
Dental Handpieces (Brand: Jinme, Model: J1/J1 Plus-Tu, M1-R/U-CA, M1-SH-A, Ying-Su-B2/M4, Ying-Tu-B2/M4 |
155 |
JMDZ20220921, date: 21/09/2022 |
USD 2885.00 |
Rashi International Import Export (Pvt) ltd |
Guandgong Jinme Medical Technology Co.ltd - China |
Reason not mentioned. |
Manufacturer was registered with Rivomed Holdings (Pvt) ltd. Registration granted for these items on 07.10.2019. (D/2296) No agency transfer process instated up to now. |
Not recommended and advised to register the product. |
05 |
17/10/2022 |
MD/1159/10/2022 |
Thromboelastomy Reagents |
As per the invoice |
PORD-000730, date: 06/07/2022 |
EUR 11,756.39 |
Surgicare (Pvt) ltd |
TEM Innovations - Germany |
For TH - Kalubowila, National Hospital of Sri Lanka, TH - Peradeniya, Directorate of Army Medical Procurement Services |
Product registered valid up to 30.01.2022.But not enough quality from Germany site manufacturer declared. Real site of above products are Switzerland and UK. |
Not recommended. Expedite the registration. Advised to submit dossier for registration. |
06 |
19/10/2022 |
MD/1172/10/2022 |
1. Catheter mount 2. Anesthesia Breading circuits |
207 Carton (475 Pcs) |
CRR224023, date: 29/07/2022 |
USD 500.00 |
Medilon Equipment (pvt) ltd |
Shanoxing Carere Medical Appliance Co.ltd - China |
For Clear the shipment. |
- Manufacturer not registered with NMRA. - For Catheter mount, for registered supplier are available and one registered supplier available for breading circuit. |
Not recommended and advised to register the product. |
07 |
11/10/2022 |
MD/1174/10/2022 |
Blood Glucose Monitoring System with Standard Accessories/Blood Glucose Test Strips with or without Lancet (Brand: BG-PRO) |
3300 |
PI220920-1, date: 20/09/2022 |
USD 7,200.00 |
George Steuart Health (Pvt) ltd |
Wellan Tech Co.ltd - Taiwan |
For the Market |
Previous product (Major II Blood Glucose Monitoring System) discontinued by the manufacturer and the local agent decided to register a new product. File submitted for registration on September 2022. (D/4300, D/4301) (Allocated to P25) |
Not recommended. Expedite the registration. |
08 |
28/10/2022 |
MD/1180/11/2022 |
Spare Parts for Anesthesia Machine (Brand: GE Datex Ohmada) |
75 |
HSKDD00082, date: 26/08/2022 |
USD 12,073/- |
Biomed International (Pvt) ltd |
Datex Ohmeda Inc - USA |
For several government hospitals. (Colombo East Base Hospital, District General Hospital - Matara, Teaching Hospital - Auradapura) |
Already registered product and full registration expired in June 2022. (DVR/16091) Manufacturer discontinued the product and requesting WOR to import Spare Parts) |
Recommended only for this consignment. |
09 |
28/10/2022 |
MD/1183/11/2022 |
Blood Glucose Test Strips (Brand: One Touch Select Plus Test Strips) |
22,000 |
272716, date: 19/10/2022 |
USD 76,241.00 |
Sunshine Healthcare |
LifeScan Europe GmbH - Switzerland |
To prevent the Out of stock situation in the market. |
File submitted on September 2022 under processing. (D/4331 - Allocated to P42) |
Not recommended. Expedite the Registration. |
10 |
28/10/2022 |
MD/1187/11/2022 |
Spare Parts of Defibrillators |
As per the Invoice |
LDA03072022, date: 07/03/2022 |
$16,439.76 |
Hemas Surgicals & Diagnostics (Pvt) ltd |
Nihon Kohden - Japan |
For Suwasariya 1990 |
Requesting WOR for Spare parts od already installed Defibrillators. (Model: Lifeline Aed) Agency transfer letter relevant to this model not attached with a request by Hemas. |
Recommended only for this consignment. |
11 |
28/10/2022 |
MD/1188/11/2022 |
Spare Parts of Patient Monitors |
As per the Invoice |
10031921, date: 18/10/2022 |
USD 50,605.29 |
Hemas Surgicals & Diagnostics (Pvt) ltd |
Nihon Kohden - Japan |
For Teaching Hospital - Batticaloa |
New manufacturing site. Manufacturing site still not registered and NMRA requested additional data for a registration. (FMSA/MD/2026) |
Recommended only for this consignment. |
12 |
28/10/2022 |
MD/1189/11/2022 |
Spare Parts of Patient Monitors |
44 |
10031735, date: 18/10/2022 |
USD 5,808.46 |
Hemas Surgicals & Diagnostics (Pvt) ltd |
Nihon Kohden - Japan |
For China-Sri Lanka Friendship National Nephrology Specialized Hospital - Polonnaruwa |
New manufacturing site. Manufacturing site still not registered and NMRA requested additional data for a registration. (FMSA/MD/2026) |
Recommended only for this consignment. |
13 |
28/10/2022 |
MD/1190/11/2022 |
Standard Accessories for Sterilizer Stem and Spare Parts (Getinge Steam Sterilizer) |
As Per the Invoice |
8085412503, date: 13/10/2022 |
USD 17,100.16 |
Mediquipment Limited |
Getinge Sterilization AB - Sweden |
For Mahaoya Base Hospital |
Registration expired on 2019 and product discontinued by the manufacturer. (DVR/11509) Requesting WOR for Repairing the stream sterilizer at Mahaoya Base Hospital) |
Recommended only for this consignment. |
14 |
28/10/2022 |
MD/1191/11/2022 |
Antibacterial Wound Dressing with Copper |
500 |
EI228000048, date: 18/08/2022 |
USD 1,340.00 |
E & H Holdongs Lanka (Pvt) ltd |
MEDCU Technologies Ltd - Israel |
Manufacturing site registered in November 2022. (FMSA/MD/2021/46) File still not submitting for register the product. |
Not recommended and advised to register the product. |
|
15 |
10/11/2022 |
MD/1204/11/2022 |
Heamostasis Introducer (Introducer Sheath) |
600 |
20220906004, date: 06/09/2022 |
USD 12,150.00 |
Kish International (Pvt) ltd |
APT Medical Inc - China |
File submitted for registration on April 2022. Under processing. (D/4052 - Allocated to P39) |
Not recommended. Expedite the registration. |
|
16 |
08/11/2022 |
MD/1205/11/2022 |
Powder for production of Liquid Bicarbonate Concentrator for Bicarbonate Haemodialysis (Bibag 5008) |
20,000 PCE |
4503184353 date: 20/09/2022 |
EUR 16,600.00 |
Fresenius Medical Care Lanka (Pvt) Ltd |
Fresenius Medical Care AG & Co. KGaA - Germany |
For Haemodialysis Treatments |
Product earlier registered under medicine. New file D/4178 submitted in June 2022 to register as Medical Device. (Allocated to P47) |
Not recommended. Expedite the registration. |
17 |
15/11/2022 |
MD/1207/11/2022 |
Pharmacy Refrigerator (Brand: Haier, Mode: HYC-310) |
560 |
HRP-005-Biomedica-2022, date:03/11/2022 |
USD 1,320.00 |
Biomedica (Pvt) ltd |
Haier Biomedical Co.ltd - China |
For DDHS - Galle |
Grace period given for registration of Pharmacy Refrigerator until June 2023 by NDEC. |
Recommended only for this consignment. |
18 |
15/11/2022 |
MD/1208/11/2022 |
Hydrophobic Acrylic Intraocular Lens |
1000 |
3086, date: 17/10/2022 |
USD $ 45,800.00 |
Platinum Healthcare (Pvt) ltd |
USIOL from Lexington - USA |
New Manufacturer. |
Not recommended and advised to register the product. |
|
19 |
15/11/2022 |
MD/1209/11/2022 |
Dental Chair and Accessories Related to Dental Work |
1 |
MS-20221008, date: 08/10/2022 |
USD 2550.00 |
Polwaththa Rathubadhuge Dilusha Jayani (Dental Surgeon) |
Chengdu Maisheng Medical Equipment Corporate Limited - China |
Use for Private Dental Clinic - Matara. |
New Manufacturer. Requesting WOR for import one unit by a dental surgeon Dr. Dilusha Jayani. |
Recommended only for this consignment. Advised to submit English Documents for your request. (Business License, Medical Device Certificate, Test report and ISO Certificate) |
20 |
15/11/2022 |
MD/1210/11/2022 |
Immunohistochemistry Reagents |
4 |
311348984, date: 01/09/2022 |
USD 2552.84 |
A & M Suhada Enterprises (Pvft) ltd |
Agilent Technologies Singapore (International) Pte Ltd - Singapore. |
For Medical Research Institute. |
Manufacturer registered with NMRA and Sample import License granted recently. |
Recommended only for this consignment. |
21 |
08/11/2022 |
MD/1211/11/2022 |
E.C.G. Recording Paper |
14,500 Rolls |
EP/CC/02-2022, date: 12/10/2022 |
USD 4735.00 |
Emar Pharma (Pvt) ltd |
M/s. Chhenna Corporation - India |
For Several Private Institute |
Full registration expired in March 2022. (DVR/16850) and delay submission of re-registration on September 2022. (D/4292, Allocated to P47) |
Recommended only for this consignment. |
22 |
08/11/2022 |
MD/1212/11/2022 |
Warming Solution Sets and Cryotec |
20 + 100 |
22092302, date: 23/09/2022 |
Yen 1,545,000.00 |
Vindana Reproductive Health Centre (Pvt) ltd |
Reprolife Inc - Japan |
For In-vitro fertilization (IVF) treatment Services. |
|
Recommended only for this consignment. |
23 |
08/11/2022 |
MD/1213/11/2022 |
Assy, four button foot pedal Wireless (Brand: Whitestar Signature PRO) |
1 |
94959, date: 27/10/2022 |
USD 9950.90 |
Hemas Pharmaceuticals (Pvt) ltd |
Johnson & Johnson Surgical Vision Inc - USA |
For Whitestar Signature PRO System |
Accessories for already registered Phacoemulsification Stem. (D/1904) And this item is not included in the existing annexure list. |
Recommended only for this consignment. |
24 |
08/11/2022 |
MD/1214/11/2022 |
Tennis & Golf Elbow Wrap and others |
As per the invoice |
OP01-202210014, date: 20/10/2022 |
USD 91326.79 |
Hemas Surgical & Diagnostics (Pvt) ltd |
OPPO Medical Corporation - Taiwan |
Already registered product and agency transfer to Hemas. Due to manufacturing site changed, New site registered in July 2022 and Sample license applied in September 2022. |
Recommended only for this consignment. |
|
25 |
08/11/2022 |
MD/1215/11/2022 |
Knee Support and others |
As per the invoice |
P01-202210006, date: 06/10/2022 |
USD 345,349.67 |
Hemas Surgical & Diagnostics (Pvt) ltd |
OPPO Medical Corporation - Taiwan |
Already registered product and agency transfer to Hemas. Due to manufacturing site changed, New site registered in July 2022 and Sample license applied in September 2022. |
Recommended only for this consignment. |
|
26 |
08/11/2022 |
MD/1216/11/2022 |
Thinkpulse Active Electrode Kits for Academic Purpose |
2 |
D2394, date: 29/07/2022 |
USD 349.99 |
Dr. M.S. Wickramasinghe, Senior Lecturer, Department of Computer Engineering, Faculty of Engineering, University of Peradeniya |
Conscious Labs - France |
For Research Purpose. |
|
Recommended only for this consignment. |
27 |
09/11/2022 |
MD/1218/11/2022 |
Bracytherapy Training Simulator for Cervial Cancer |
1 |
ME-010-7-2210, date: 28/10/2022 |
JPY 385,000 |
Ministry of Health |
Chiyoda technol Corporation - Tokyo |
For Strengthening Cancer Management Programmes. |
|
Recommended only for this consignment. |
28 |
12/09/2022 |
MD/1107/09/2022 |
Microscope (Brand: Xeiss, Model: Vario 700) |
1 |
44113584, date: 19/07/2022 |
Euro 2,700.00 |
Queensbury Hospitals (Pvt) ltd |
Carl Zeiss AG - Germany |
For Teaching Purpose |
Manufacturer is registered with Dimo (Pvt) ltd.
Submitted to WOR Committee held on 08/10/2022 and Decision was Pending. Advised to submit the Private Health Services Regulatory Council Registration Certificate and Evidence of Teaching activities related to this field of medical device. |
Recommended only for this consignment. |
19/11/2022 - S.P.C |
|||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Invoice Value |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
Remarks |
WOR Committee Approval |
01 |
17/10/2022 |
MD/1155/10/2022 |
DNA Whole Blood Kits |
54 Kits |
LP/DHS/LB/DQ/03/45SM/20, date: 13/12/2019 |
LKR 1,863,000.00 |
Emar Pharma (Pvt) ltd |
RBC Bioscience Corp. - Taiwan |
SPC Tender |
File not submitted for registration. |
Recommended only for this consignment. |
02 |
19/10/2022 |
MD/1167/10/2022 |
Sodium Perborate Monohydrate 50% Powder Mix |
45,000L |
DHS/P/WW/284/22, date: 2/6/2022 |
USD 4,963.00 |
abcpharma |
Sirmaxo Chemicals (Pvt) ltd |
SPC Tender |
BWD. 04.01.2017. Circular No: P-01/02/2017. Bath withdraw Due to more complaint from different institutions. New local agent has submitted new dossier for registration. (D/4341, evaluation) |
Not recommended. Expedite the registration. (Product dossier in evaluation stage by Microbiology) |
03 |
20/10/2022 |
MD/1168/10/2022 |
Re-usable Instruments for ENT surgery (Antral Trocar - Article no EJ316R, Tongue Despressor - Article no OM205R, Nasal Antrum Cannula - Article no OK874C, Nasal Antrum Cannula - Article no OK877R) |
07+625+15+13 |
DHS/S/WW/44/748AK/21 |
USD 4890.82 |
B Braun Lanka |
Aesculap AG - Germany |
SPC Tender |
Manufacturer registered with this local agent. Registered Source available. |
Not recommended and advised to register the product. (Advised to submit the dossier for registration at NMRA or purchase from the registered supplier.) |
04 |
25/10/2022 |
MD/1175/10/2022 |
Heat and Moisture Exchange Filter (Brand: Sterimed, odel: Adult/Pediatric) |
Adults - 237,500 , Pediatric - 31,250 |
DHS/M/S/WW/14/21, date: 03/10/2022 |
USD 5,313.00 , 625.00 |
Sunshine Healthcare |
Sterimed Surgicals India (Pvt) ltd - India |
SPC Tender |
- - Manufacturer registered with NMRA. - - Submission of Sample import license reference nu not mentioned in the request and according to NMRA Sample import license database, only applied Sample Import License for ET tube and Foley catheter. |
Not recommended. Advised to submit the file for registration. (Tender not awarded so far. Advised NMRA to expedite if submit file for registration) |
05 |
25/10/2022 |
MD/1176/10/2022 (MD/1135/10/2022) |
Pacing Lead (Brand: Medtronic, Model: 5076) , Rercutaneous Lead Introducer (Brand: Medronic, Model: 6207) |
900 NOS |
DHS/M/SS/WW/4/565DP/2021, date: 12/07/2022 |
US $ 562,500.00 |
Medrac (Pvt) ltd |
Medtronic Inc - USA |
SPC Tender |
Registered manufacturer site with Medtrac (Pvt) ltd. (SIL 4785/01/2022) Submitted to WOR Committee held on 08/10/2022 and Decision was Pending. Advised to request the registration certificate include the accessories. |
Not recommended. Expedite the registration. Advised to request the registration certificate include the accessories. |
06 |
25/10/2022 |
MD/1177/10/2022 (MD/1136/10/2022) |
Rercutaneous Lead Introducer (Brand: Medtronic, Model: 6207, 6209) , Facing Lead (Brand: Medtronic, Model: 5076, 6935M) |
720 NOS |
DHS/M/SS/WW/5/573DP/2021, date: 22/07/2022 |
US $ 1,134,000.00 |
Medrac (Pvt) ltd |
Medtronic Inc - USA |
SPC Tender |
Registered with Medtrac (Pvt) ltd for "Vitatron MRI Surescan" single chamber pacemaker. (Ref:D-3388) (SIL under processing) |
Not recommended. Expedite the registration. Advised to request the registration certificate include the accessories. |
07 |
15/11/2022 |
MD/1217/11/2022 |
Immunohistochemistry Reagents |
58 |
DHS/RL/62/24SSN/2021, date: 11/10/2022 |
USD 33,968.00 |
A & M Suhada Enterprises (Pvft) ltd |
Agilent Technologies Singapore (International) Pte Ltd - Singapore. |
SPC Tender |
For SPC Supply. Manufacturer registered with NMRA and Sample import License granted recently. |
Recommended only for this consignment. |
Waiver of Registration Committee - Device (January 2022 to June 2022) |
|||||||||||||||||||||
08/01/2022 |
|||||||||||||||||||||
No |
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Applicant |
Manufacturer/Supplier |
Reason for WOR |
WOR Committee Decision |
|||||||||||||
1 |
16/12/2021 |
MD/434/12/2021 |
EMV+731 Series Ventilator with Standard Accessories & Spare Parts |
2 |
Diligence Healthcare (Pvt) ltd |
Zoll Medical Corporation - USA |
Donation to Ministry of Health |
Recommended only for this consignment. |
|||||||||||||
2 |
16/12/2021 |
MD/435/12/2021 |
Ventilator Spare Parts |
1 |
Diligence Healthcare (Pvt) ltd |
Zoll Medical Corporation – USA. |
Donation to Ministry of Health |
Recommended only for this consignment. |
|||||||||||||
3 |
16/12/2021 |
MD/445/12/2021 |
Electric Wheel Chair |
1 |
Melson Camild Fernando |
Ningbo Baichen Medical Devices Co.ltd - China |
For Personal use. |
Recommended only for this consignment. |
|||||||||||||
4 |
11/11/2021 |
MD/453/12/2021 |
Horse Serum |
1 |
Sri Lanka Standards Institution |
For Sri Lanka Standers Institution |
Recommended only for this consignment. |
||||||||||||||
5 |
20/12/2021 |
MD/455/12/2021 |
ELISA Kits |
8 |
Shani Weerasekara, Insitute of Indigenous Medicines, Uniersity of Colombo, Rajagiriya. |
ElabScience Biotechnology Inc - USA |
For Research Purpose. (To complete Master of Philosophy (Mphil) Degree at Facalty of Graduate Studies, University of Kelaniya) |
Recommended only for this consignment. |
|||||||||||||
6 |
17/12/2021 |
MD/456/12/2021 |
Covid 19 Antigen Lateral Flow Test Device OTC Home Test |
50 |
Apcot Marketing (Pvt) Ltd |
M/S Mylab Discovery Solutions Pvt. Ltd - India |
Not recommended and advised to register the product. |
||||||||||||||
7 |
20/12/2021 |
MD/458/12/2021 |
Oxygen Concentrator (5l) |
1 |
G. Muthumala Motor Stores Colombo (pvt) ltd |
Only one unit for personal use. |
Recommended only for this consignment. Only to be used for said purpose and not for commercial purpose. |
||||||||||||||
8 |
22/12/2021 |
MD/471/12/2021 |
Surgical Mask/Shoe Cover/Head Cap |
180,000 |
Basilur Tea Export (Pvt) ltd |
Nanjing Kaihong Healthcare Co. - China |
Recommended. WOR Only for Shoe Cover and Head Cap. WOR not recommended for surgical mask. |
||||||||||||||
9 |
22/12/2021 |
MD/474/12/2021 |
Medical Equipments |
|
Sri Lanka Army |
M/S Ottobock SE & Co.KGaA - Germany |
For Army |
Recommended only for this consignment. |
|||||||||||||
10 |
24/12/2021 |
MD/489/12/2021 |
Electric Saw |
1 |
Co-op Hospital - Eravur |
Wuhu Ruijin Instrument & Device Co.ltd - China |
Not recommended and advised to register the product. |
||||||||||||||
11 |
24/12/2021 |
MD/478/12/2021 |
Ventilator Spare Parts |
|
Diligence Healthcare (Pvt) ltd |
Zoll Medical Corporation - USA |
|
Recommended only for this consignment. |
|||||||||||||
12 |
24/12/2021 |
MD/488/12/2021 |
Portable Stretchers |
40 |
Korean Lanka Holding |
Zhangjiangang Hishesee Co.ltd - China |
For Chief Mechanical Engineering Office, Sri Lanka Railways, Rathmalana. |
Recommended only for this consignment and advice to register as class I medical device. |
|||||||||||||
13 |
24/12/2021 |
MD/477/12/2021 |
Gene Xpert Xpres-Sars-Cov-2 |
30 |
Analytical Instruments (Pvt) ltd |
Cepheid - France |
For WHO |
WOR Not Recommended. Expedite the registration process. |
|||||||||||||
14 |
24/12/2021 |
MD/482/12/2021 |
Spare Parts for Sterilizer System |
|
Mediquipment Limited |
Getinge Sterilization AB - Sweden |
Repaired Item |
Recommended only for this consignment. |
|||||||||||||
15 |
24/12/2021 |
MD/483/12/2021 |
IHC Reagents |
11 |
A & M Suhanda Enterprises (Pvt) ltd |
Agilent Technologies - Sinapore |
|
Recommended only for this consignment. |
|||||||||||||
16 |
24/12/2021 |
MD/485/12/2021 |
Thromboelastomy Reagents |
|
Surgicare (Pvt) ltd |
TEM Innovations - Germany |
Not Recommended and advised to purchase from the registered Manufacturer. |
||||||||||||||
17 |
24/12/2021 |
MD/481/12/2021 |
Spare Parts for Ultrasound Diagnostic System |
1 |
Biomed International (Pvt) Ltd |
GE Medical Systems Co. ltd - China |
For Teaching Hospital - kandy |
WOR Not Recommended. Amend the certificate to include accessory list. |
|||||||||||||
18 |
24/12/2021 |
MD/480/12/2021 |
Multi-Drug 6 Drugs Test Cup with Indicator (Saliva) (CE) |
5,000 |
Divasa Pharma Ltd |
Hangzhou Biotest Biotech Co.ltd - China |
For National Dangerous Drugs Control Board. (Already have site registration) |
Recommended only for this consignment. |
|||||||||||||
19 |
04/01/20222 |
MD/498/01/2022 |
Hospital Beds and Equipments |
U.P.S. Rodrigo |
Lak Saviya Foundation - Australia |
Donation from Laksaviya Foundation – Australia to several government institution. |
Recommended only for this consignment. |
||||||||||||||
20 |
30/12/2021 |
MD/504/01/2022 |
Ultrasound Spare Parts |
1 |
Biomed International (Pvt) Ltd |
GE medical Systems Co.ltd - China |
For National Hospital in Sri Lanka (NHSL) |
Not recommended to issue WOR. Advised to amend the certificate to include accessory and spare parts list. |
|||||||||||||
21 |
31/12/2021 |
MD/511/01/2022 |
Oppo Orthopedic |
43,725 |
Hemas Surgicals & Diagnostics (Pvt) ltd |
Plus Meditech Co.ltd - Taiwan |
Recommended only for this consignment. |
||||||||||||||
22 |
31/12/2021 |
MD/497/01/2022 |
Orafil G (100 Packs) |
100 (Packs) |
Yu and Company (Pvt) ltd |
Prevest Denpro Ltd - India |
Recommended only for this consignment. |
||||||||||||||
23 |
31/12/2021 |
MD/501/01/2022 |
Smart bag 211.50 |
Fresenius Medical Care |
Fresenius Medical Care - Germany |
Recommended only for this consignment. |
|||||||||||||||
24 |
17/09/2021 |
MD/125/09/2021 |
Pulse Oximeter (P-01, P-05) |
2,000 |
Wintech Cellukar Services, |
Shenzhen Jiangnan Medical Technology Co.ltd - China |
For Covid 19 Pandemic Situation in Sri Lanka |
Not recommended. Due to unsatisfactory clinical performance. |
|||||||||||||
25 |
8/9/2021 |
Pulse Oximeter (Model - YK 81C) |
10000 |
Research Instrunment Pvt ltd |
Xuzhou Yongkang Electronic Science Technology Co.ltd - China |
Recommended only for this consignment. (Only 5000 units) |
|||||||||||||||
26 |
17/09/2021 |
MD/128/09/2021 |
Pulse Oximeter (OX-02) |
300 |
P. Amila Rangana Nonis |
Shenzhen Tablet Electronics ltd - China |
WOR Not recommended and advised to re-export. Due to unsatisfactory clinical and technical performance. |
||||||||||||||
27 |
6/10/2021 |
MD/225/10/2021 |
Fingertip Pulse Oximeter (Model: YK-81B) |
1,000 |
Taprobana Island (pvt) ltd |
Xuzhou Yongkang Electronic Science Technology Co.ltd - China |
Recommended only for this consignment. |
||||||||||||||
28 |
6/10/2021 |
MD/226/10/2021 |
Fingertip Pulse Oximeter (Model: YK-80B) |
2,000 |
Taprobana Island (pvt) ltd |
Xuzhou Yongkang Electronic Science Technology Co.ltd - China |
Not recommended and advised to re-export. Due to unsatisfactory clinical and technical performance. |
||||||||||||||
29 |
9/9/2021 |
Pulse Oximeter (Model-YBM 303) |
20 |
Vikum Shaminda, |
Henan Yobekan Medical Equipment Co. ltd - China |
Personal Use |
Not recommended and advised to re-export. Due to unsatisfactory clinical performance. |
||||||||||||||
30 |
17/09/2021 |
MD/123/09/2021 |
Fingertip Pulse Oximeter (YK-81C) |
20,000 |
One Legacy (pvt) ltd |
Xuzhou Yongkang Electronic Science Technology Co.ltd - China |
For Governmental, Private Medical Institutions and Local Pharmacies |
Recommended only for this consignment. |
|||||||||||||
31 |
17/09/2021 |
MD/126/09/2021 |
Pulse Oximeter (YM102) |
200 |
Devro International |
Shenzhen Yimi Life Technology Co.ltd - China |
Not recommended and advised to re-export. Due to unsatisfactory clinical performance. |
||||||||||||||
32 |
9/9/2021 |
Pulse Oximeter (Model-P01) |
100 |
M.H.M. Sharaf Deen |
Shenzhen Jiangnon Medical Technology Co.ltd - China |
Not recommended and advised to re-export. Due to unsatisfactory clinical and technical performance. |
|||||||||||||||
33 |
6/10/2021 |
MD/223/10/2021 |
Fingertip Pulse Oximeter (Model:MD300CN310) |
250 |
D & W Associates International (Pvt) ltd |
Beijing Choice Electronic Technoly Co.ltd - China |
Recommended only for this consignment. |
||||||||||||||
34 |
8/9/2021 |
Fingertip Pulse Oximeter (Model : C101 H1) |
10000 |
E Friends |
Shenzhen IMDK Medical Technology Co.ltd - China |
Not recommended and advised to re-export. Due to unsatisfactory clinical performance. |
|||||||||||||||
35 |
17/09/2021 |
MD/106/09/2021 |
Pulse Oximeter |
500 |
Clinivex (Pvt) ltd |
Shenzhen Gemeitong Technology Co.ltd - China |
For Personal Use, mainly for their own Staff and client with whom their associate frequently. |
Not recommended and advised to re-export. Due to unsatisfactory clinical and technical performance. |
|||||||||||||
36 |
17/09/2021 |
MD/99/09/2021 |
Fingertip Pulse Oximeter (YXY018A) |
100 |
Sandun Lahiru Kulathilaka |
Shenzhen E-Champion Technology Co.ltd - China |
Not recommended and advised to re-export. Due to unsatisfactory clinical and technical performance. |
||||||||||||||
37 |
10/12/2021 |
MD/431/12/2021 |
Lactate Analyzer |
Sui Generis (pvt) ltd |
Apex Biotechnology Co - Taiwan |
For Institute of Sport Medicine |
Not recommended. Advised to re-export and purchase from registered source. |
||||||||||||||
38 |
3/11/2021 |
MD/326/11/2021 |
Five Function Electrical Bed and Other Medical Equipments |
108 |
Kanola Hospital |
Jiangsu Saikang Medical Co.ltd - China |
For Kanola Hospital |
Not Recommended. Advised to order from registered source. |
|||||||||||||
39 |
6/11/2021 |
MD/199/10/2022 |
Tissue Vault, Cell Tissue Freezing Bag - All Size |
Dowell International (Pvt) ltd |
Origen Biomedical Inc - USA |
For Lady Ridgway Hospital |
Recommended only for this consignment. |
||||||||||||||
40 |
14/09/2021 |
MD/81/09/2021 |
Fingertip Pulse Oximeter (LK87) |
15000 |
Best Way Logistics (Pvt) ltd |
Shenzhen Linke Technology Co.ltd - China |
For Sales |
Not recommended and advised to re-export. Due to unsatisfaction clinical and technical performance. |
|||||||||||||
41 |
17/09/2021 |
MD/112/09/2021 |
Fingertip Pulse Oximeter |
100 |
K.B.A Chamara Prabath |
Sichuan Fu Yousi Co.ltd - China |
Not recommended and advised to re-export. Due to unsatisfaction clinical and technical performance. |
||||||||||||||
42 |
6/10/2021 |
MD/219/10/2021 |
Hydraguard + Antimicrobial Nano Coating |
1 |
Junaht International (pvt) ltd |
Safespaceinnovations(pvt) ltd - India |
For Private and Government Sector |
WOR Not recommended. Advised to submit more applied research evidence on the efficacy, performance and data on traceability, evidence of the use of the said product in other countries. |
|||||||||||||
43 |
7/1/2022 |
MD/513/01/2022 |
N95 Masks |
UNOPS - Sri Lanka. |
Makrite Industries Inc / Dongguan Sure_On Plastic & Fiber Products Co.ltd - China |
For MOH |
Recommended only for this consignment. |
||||||||||||||
44 |
7/1/2022 |
MD/514/01/2022 |
Hospital Beds / Wheel Chairs |
68 + 08 |
Shraddha Charity Organization |
For Government Institute |
Forwarded to CEO for necessary action. |
||||||||||||||
45 |
7/1/2022 |
MD/515/01/2022 |
Hospital Beds |
9 |
Rohini Chandra Fernando |
For Apeksha Hospital- Maharagama (Donate from Australia) |
Forwarded to CEO for necessary action. |
||||||||||||||
46 |
7/1/2022 |
MD/516/01/2022 |
Test Strips for Blood Glucose Monitoring System (MEGACHECK) |
12,000 |
Mega Meditech (Pvt) ltd |
TaiDoc Technology Coroparation Wugu Factory - Taiwan |
Not Recommended. Advised to request for extension of existing registration certificate. (FR) |
||||||||||||||
47 |
5/1/2022 |
MD/517/01/2022 |
Ovulation Test Kits |
1 |
Mariam Omar |
For Personal Use |
Not Recommended. Advised due to inadequate documents. |
||||||||||||||
48 |
5/1/2022 |
MD/518/01/2022 |
Surgical Blades |
100,000 |
Hayleys Agro Biotech (Pvt) ltd |
For Sri Lanka Export Development Board |
Not Recommended. (Purchase from registered source) |
||||||||||||||
49 |
5/1/2022 |
MD/519/01/2022 |
Panthera C2 Trinocular 50: 50 / 0.4X C-mount camera adapter / BMH1080-U / SMZ171-TLED / 2.0X Objective for SMZ161/SMZ171 / 0.4X C-mount camera adapter |
3 + 3 + 3 + 3 + 3 + 3 |
Anti-Malaria Campaign |
World Health Organization |
For Anti Malaria Campaign |
Not Under NMRA Preview. (Product Categorization) |
|||||||||||||
50 |
8/1/2022 |
MD/520/01/2022 |
Syringe Pump for Fluid Management /Including Software with standard Accessories & Spare Parts |
550 |
Akbar Pharmaceuti cals (Pvt) Ltd |
Smith Medical Instruments Co.ltd - China |
Not recommended. As agency transfer letter not available. |
||||||||||||||
51 |
8/1/2022 |
MD/521/01/2022 |
Wheel Chair |
100 |
Sahana Sarana Social Welfare Foundation |
Donation |
Recommended only for this consignment. |
||||||||||||||
52 |
8/1/2022 |
MD/522/01/2022 |
DENTSPLY Millefleur Protaper |
Dr. Janaka Abeywardhana |
Recommended only for this consignment. |
||||||||||||||||
53 |
8/1/2022 |
MD/524/01/2022 |
Disable Wheel Chair |
9 |
Unique Tools and Machineries (Pvt) ltd |
Dongguan Yattll Industry Co.ltd - China |
Commercial Purpose |
Not recommended and advised to register the product. |
|||||||||||||
54 |
8/1/2022 |
MD/525/01/2022 |
Artificial Limbs Kits |
Colombo Friend in Need Society |
Recommended only for this consignment. |
||||||||||||||||
55 |
8/1/2022 |
MD/527/01/2022 |
Spirometer with Standard Accessories & Spare Parts (Vitalograph - 2120 Inzitive) |
2 |
Delmege Forsyth & Co. ltd |
Vitalograph (Irelan) ltd |
For En Project - Kalutara District Specialized Maternal & Children Hospital. |
Not Recommended issuing WOR. Advised to use Sample Import License and register the product. |
|||||||||||||
56 |
8/1/2022 |
MD/528/01/2022 |
Urine Drainage Catheter |
159 |
R & D Intertrades (PTE) Limited |
Devon Innovations Pvt ltd - India |
Not Recommended and advised to register the product. |
||||||||||||||
57 |
8/1/2022 |
MD/526/01/2022 |
Face Masks |
Ministry of Highways (Wang Fuwen) |
Recommended only for this consignment. In future need to be purchased from local manufacturer. |
||||||||||||||||
08/01/2022 - S.P.C |
|||||||||||||||||||||
|
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Applicant |
Manufacturer/Supplier |
Reason for WOR |
WOR Committee Approval |
|||||||||||||
1 |
16/12/2021 |
MD/442/12/2021 |
Anti A Series, Anti B , Anti A,B, Anti D and Others |
|
Premium International (Pvt) ltd |
Immucor Inc - USA |
SPC Order |
Recommended only for this consignment. |
|||||||||||||
2 |
16/12/2021 |
MD/443/12/2021 |
Theraputic Plasma Exchange Kits (TPE Kits) |
2,400 |
Premium International (Pvt) ltd |
Fresenius Kubi - India |
SPC Order |
Recommended only fort his consignment. |
|||||||||||||
3 |
22/12/2021 |
MD/475/12/2021 |
Laboratory Consumables |
|
SPC (A&M Suhada 69Enterprises (Pvt) ltd |
M/s Agilent Technologies Denmark Aps - Denmark / USA |
SPC Order |
Recommended only for this consignment. |
|||||||||||||
4 |
24/12/2021 |
MD/486/12/2021 |
Tissue Embedding Cassettes |
514,000 |
Rivomed Holdings (Pvt) ltd |
Ningbo Foyomed Medical Instrument (Pvt) ltd - China |
SPC Order |
Not recommended and advised to register the product. |
|||||||||||||
5 |
24/12/2021 |
MD/487/12/2021 |
Biopsy Embedding Cassettes |
334,000 |
Rivomed Holdings (Pvt) ltd |
Ningbo Foyomed Medical Instrument (Pvt) ltd - China |
SPC Order |
Not recommended and advised to register the product. |
|||||||||||||
6 |
24/12/2021 |
MD/479/12/2021 |
Arterial Leader Cath |
|
tmi Solution (Pvt) ltd |
M/S Vygon S.A - France |
SPC Order |
Recommended. Extend the already issued WOR. |
|||||||||||||
7 |
24/12/2021 |
MD/484/12/2021 |
Immunohistochemistry Reagents |
13 |
A & M Suhanda Enterprises (Pvt) ltd |
Agilent Technologies - Sinapore |
SPC Order |
Recommended only for this consignment and expedite the registration. |
|||||||||||||
8 |
18/08/2021 |
MD/494/12/2021 |
Talc Powder Sterile 4g Bottle |
|
Instrumedic International (Pvt) ltd |
M/s. Novatech SA - France |
Submitted to WOR Committee held on 28/10/2021 and Committee Decision was Not Recommended and advised to register the product. SPC tender dossier not submitted. |
Recommended only for this consignment. |
|||||||||||||
9 |
7/12/2021 |
MD/426/12/2021 |
Dental Instruments |
611 |
Rivomed Holdings (Pvt) ltd |
ASA Dental S.P.A - Italy |
Submitted to WOR Committee held on 11/12/2021 and Committee Decision was Not Recommended and advised SPC to bring their technical evaluation file. |
Recommended only for this consignment. |
|||||||||||||
10 |
8/1/2022 |
MD/523/01/2022 |
Sodium Bicarbonate Powder for Heamodialysis |
5,376 |
Fresenius Medical Care |
Fresenius Medical Care - Germany |
SPC Order |
Recommended only for this consignment. |
|||||||||||||
12/02/2022 |
|||||||||||||||||||||
|
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Applicant |
Manufacturer/Supplier |
Reason for WOR |
WOR Committee Approval |
|||||||||||||
1 |
24/12/2022 |
MD/529/01/2022 |
Wallace Catheters & Oocyte recovery set. |
285 |
A. Baur & Co.(Pvt) ltd |
Cooper Surgical Inc - USA |
For several Hospitals in Sri Lanka (Lanka Hospital PLC/ Nawaloka Hospitals PLC & Vindana Reproductive Health Centre) |
Not Recommended. To be considered after getting NOL from the registered Local Agent. |
|||||||||||||
2 |
19/01/2022 |
MD/553/01/2022 |
TC 99m Dry Tec Generator (6GBq), DMSA, Bridate Bromo - Billiaron, Mag3, Nanocol |
26/36/ 12/36/ 12 |
Medical Supplies Division |
Ezacibasis - Monrol Nuclear Products Co. – Turkey / Medi - Radiopharna Kit - Hungary |
For Medical Supplies Division |
Recommended only for this consignment. Advised to submit Pro-forma Invoice. |
|||||||||||||
3 |
1/2/2022 |
MD/565/02/2022 |
Hospital Bed Manual Adjustable and Standard Accessories, Spare Parts |
200 |
Gene Diagnostics |
Jiangsu Keling Medical Appliances Co.ltd - China |
PDHS - Anuradhapura |
Recommended with condition. (To be issued WOR subject to submission of free sale certificate) |
|||||||||||||
4 |
09/02/2022 |
MD/574/02/2022 |
Surgical Masks |
26600 |
Medical Supplies Division |
UNICEF - Denmark |
Donation to MSD |
Recommended only for this consignment. |
|||||||||||||
5 |
09/02/2022 |
MD/575/02/2022 |
Ventilators |
1 |
Medical Supplies Division |
Developing EM-a nonprofit organization |
Donation to MSD |
Recommended only for this consignment. To be issued WOR subject to submission of ISO, EC and Free sale certificate |
|||||||||||||
6 |
09/02/2022 |
MD/576/02/2022 |
Aleve Filariasis Strip |
30 |
International Organization for Migration (IOM) |
Abbott Rapid Diagnostics SCA - USA |
For IOM |
Recommended only for this consignment. |
|||||||||||||
7 |
09/01/2022 |
MD/577/02/2022 |
Immunohistochemistry Reagents |
|
A & M Suhada Enterprises (Pvt) Ltd |
Agilent Technologies Singapore (International) Pte Ltd - Singapore |
for University of Colombo |
Not recommended and expedite the registration. |
|||||||||||||
8 |
09/02/2022 |
MD/578/02/2022 |
Pharmacy Refrigerators |
7 |
Biomedica (Pvt) ltd |
Haier Biomedical Co.ltd - China |
UNOPS Purchase Order |
Recommended only for this consignment |
|||||||||||||
9 |
11/02/2022 |
MD/579/01/2022 |
Syringe Pump for Fluid Management /lading Software with standard Accessories & Spare Parts |
550 |
Akbar Pharmaceuticals (Pvt) ltd |
Smith Medical Instruments (Zhejiang) Co.ltd - China |
|
Recommended. To be issued WOR subject to submission of NOL from Technomedics. |
|||||||||||||
10 |
11/02/2022 |
MD/581/02/2022 |
Surguard Needle / 1ml Syringe / Semi Blunt Sterican Cannula |
2400 / 3000 / 6000 |
Hemophilia Association of Sri Lanka |
World Federation of Hemophilia - Canada |
Donation to Hemophilia Association |
Recommended only for this consignment |
|||||||||||||
11 |
11/02/2022 |
MD/582/02/2022 |
Dental Wireless Curing Light Lamp |
1 |
Dr. Shayanthy Nanthakumar |
|
For Personal Use |
Not recommended and advised to re-export. |
|||||||||||||
12 |
11/02/2022 |
MD/583/02/2022 |
Rat Insulinoma Cell Line |
1 |
Dr. M.G.A.N. Perera, Faculty of Applied Sciences, Sabaragamuwa University of Sri Lanka |
Sigma Aldrich - United Kingdom |
For Research Purpose. |
Not Recommended. Advised to submit research protocol and Ethic committee Approval. |
|||||||||||||
13 |
11/02/2022 |
MD/584/02/2022 |
Hep G2 Cell Line human |
1 |
Dr. M.G.A.N. Perera, Faculty of Applied Sciences, Sabaragamuwa University of Sri Lanka |
Sigma Aldrich - United Kingdom |
For Research Purpose. |
Not Recommended. Advised to submit research protocol and Ethic committee Approval. |
|||||||||||||
14 |
11/02/2022 |
MD/585/02/2022 |
SARS COV 2 - Antigen Strip Test |
10000 |
D & S Solutions |
Labcare Diagnostics (India) Pvt ltd - India |
For current pandemic situation and research purpose. |
Not Recommended and advised to register the product. |
|||||||||||||
15 |
03/02/2022 |
MD/567/02/2022 |
CentriMag Blood Pump System |
2 |
Chatham House (Pvt) ltd |
Thoratec Switzerland GmbH - Switzerland |
For NHSL |
Recommended only for this consignment. |
|||||||||||||
16 |
07/02/2022 |
MD/571/02/2022 |
ICU Bed and Accessories |
108 |
Kanola Hospital (Pvt) ltd |
Jiangsu Saikang Medical Equipment Co.ltd - Zhangjiagang |
Re- Appeal For Newly open hospital. |
Recommended only for this consignment. Get a report regarding actual bed capacity of the hospital from RDHS. |
|||||||||||||
17 |
18/01/2022 |
MD/558/01/2022 |
Brera - Plasmage Device (Brand : Brera / Model : Plasmage) |
1 |
Silvacos (Pvt) ltd |
Brera Medical Technologies S.R.L. - Italy |
Re- Appeal |
Not Recommended and advised to register the product. |
|||||||||||||
18 |
1/12/2021 |
MD/390/12/2021 |
Emergency Evacuation Breathing Device |
25 |
SHM Ship care (Pvt) ltd |
Lalizas - Greece |
For Marine Industries use only. |
Not Recommended and advised to register the product. |
|||||||||||||
12/02/2022 - S.P.C |
|||||||||||||||||||||
|
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
WOR Committee Approval |
|||||||||||||
1 |
12/01/2022 |
MD/554/01/2022 |
Blood Bank Reagents (Brand : ALBA Bioscience / Model : Rare Antisera) |
|
Primecare Holdings (Pvt) ltd |
ALBA Bioscience Limited - UK |
SPC Tender (DHS/L/WW/35/22) |
Not Recommended and informed that WOR may be considered only after submitting the Purchase Order issued by the SPC.
(Previous Minutes Changed as per the instruction given at the MDEC after the discussion of expertise. |
|||||||||||||
2 |
31/01/2022 |
MD/559/01/2022 |
HLA Reagents |
87 |
Emar Pharma (pvt) ltd |
M/S One Lamba - USA |
SPC Tender (LP/DHS/C/LB/DQ/01/85CPW/2020) RSSOX1A-08 RSSOX1B-11 RSSOX1C-06 RSSOX2B1-8 RSSO2Q-06 RSSO2345-06 LS1PRA-14 LS2PRA - 14 LS-NC - 08 LS-AB2 - 02 ADSORB - 10 LX4CALKT-1
LX4VERKT-1 |
Recommended with condition. (To be issued only for this Items given in the invoice) |
|||||||||||||
3 |
31/01/2022 |
MD/560/02/2022 |
Surgical Suture Absorbable Braided Silk Suture |
|
Shield Medical (Pvt) ltd |
M/S Futura Surgicare (Pvt) ltd - India |
SPC Tender (DHS/S/WW/71/270LM/2021) |
Recommended with condition. Advised to submit 1st lot delivery schedule. (Issue WOR for the 1st lot on as per the delivery schedule. Informed supplier to submit file for renewal.) |
|||||||||||||
4 |
27/10/2021 |
|
Immunohistochemistry Regents (Models: IR 50461-2 / M085101-2 / M361901-2) |
13 |
A & M Suhada Enterprises (Pvt) ltd |
Agilent Technologies - Singapore |
SPC Tender DHS/LWW/202/16WKL/2019, Date:21/07/2021 |
Recommended only for this consignment. |
|||||||||||||
5 |
11/02/2022 |
MD/580/02/2022 |
IDL Set with Accessories |
|
Hemas Surgicals & Diagnostics (Pvt) Ltd |
Terumo BCT Ltd - USA |
SPC Tender LP/DHS/SUS/WW/2/253NB/2021 |
Recommended only for this consignment. |
|||||||||||||
12/03/2022 |
|||||||||||||||||||||
|
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Applicant |
Manufacturer/Supplier |
Reason for WOR |
WOR Committee Approval |
|||||||||||||
1 |
18/02/2022 |
MD/592/02/2022 |
Vedio Colonoscopy System with Spare Parts & Standard Accessories |
2 |
Mediquipment Limited |
Olympus Medical System Corporation - Japan |
NHSL requested to repair. Now ready to return repaired item. |
Recommended only for this consignment. (Renewal of registration is under processing.) |
|||||||||||||
2 |
18/02/2022 |
MD/596/02/2022 |
Antigen Test Kit (INSTA Covid 19 Rapid Test) |
10,000 |
Majstro Health (Pvt) ltd |
M/S Seloi Health Care (Pvt) ltd - India |
For Private Hospitals |
Not recommended and advise to register the product. |
|||||||||||||
3 |
18/02/2022 |
MD/611/02/2022 |
Test Media Device |
158 |
Sunshine Healthcare Lanka Ltd |
Novo Nordisk A/S - Denmark |
Shipment Clearance |
Recommended only for this consignment. Up grated model registration is under processing. |
|||||||||||||
4 |
18/02/2022 |
MD/612/02/2022 |
One touch Delica Plus Lancets One touch Delica Plus Lancing Device |
25's x 2500
1's x 500 |
Sunshine Healthcare Lanka Ltd |
LifeScan Europe GmbH - Switzerland |
For Market (Out of stock situation in the market) |
Recommended only for this consignment. |
|||||||||||||
5 |
15/02/2022 |
MD/602/02/2022 |
· PCR Detection System. |
02
|
Biomedite (pvt) ltd |
Daan Gene Co. ltd of Sun Yat-Sen University - China. |
Lanka Hospital Diagnostics (pvt) ltd |
Recommended only for this consignment. (Only to use for Chinese people residing in Sri Lanka and out-bound travelers to china.) |
|||||||||||||
· Nucleic Acid Extraction System (Smart 32 / Swift 96) |
02
|
||||||||||||||||||||
· Nucleic Acid Extraction Kit (96/32) |
13984
|
||||||||||||||||||||
· Detection Kit 2019-nCoV (Bioperfectus Technologies / DaAn Gene) |
13952
|
||||||||||||||||||||
6 |
21/02/2022 |
MD/610/02/2022 |
Patient Monitor (Central Monitor / Bedside Monitor) |
10 |
Biomedical Engineering Services |
Nihon Kohden - Japan |
For Sri Lanka National Hospital |
Recommended only for this consignment. (As this is for NHSL - Colombo) |
|||||||||||||
7 |
22/12/2021 |
MD/468/12/2021 |
Oxygenerators / Disposable Oxygen Masks |
6
2 |
Ministry of Health |
|
Donation. For NHSL (OPD) |
Recommended only for this consignment. (As this is donation for NHSL (OPD) Colombo) |
|||||||||||||
8 |
23/02/2022 |
MD/617/02/2022 |
Continuous Renal Replacement Therapy (CRRT) Machines |
03 unit with 400 Accessories |
Diligence Healthcare (Pvt) ltd |
Infomed SA - Switzerland |
For Several Government Hospital (Base Hospitals (Theldeniya, Karawanella, Nawalapitiya, Avissawella) |
Recommended only for this consignment. (As this is donation by JICA for the MOH Sri Lanka) |
|||||||||||||
9 |
14/02/2022 |
MD/619/02/2022 |
ESR Tube for Blood Collecting Linear ESR Analyzer |
28 |
Trivitron Nawakrama Medical Technologies (Pvt) ltd |
Linear Chemicals - Spain |
For Teaching Hospital - Batticaloa and National Hospital - Kandy |
Not recommended. Expedite the registration. |
|||||||||||||
10 |
17/02/2022 |
MD/646/03/2022 |
Electric Adjustable Beds |
3 |
Comfort Bedding International (Pvt) ltd |
Zejiang Dreamotion Technology Co.ltd - China |
For study of the product and market research |
Recommended only for this consignment. Advised to submit a report to NMRA within three months. |
|||||||||||||
11 |
25/02/2022 |
MD/650/03/2022 |
Clinical Chemistry Analyzer, Reagents & Accessories & Spare Parts |
3 |
Analytical Instruments (pvt) ltd |
Thermo Fisher Scientific - USA |
For Sri Lanka Standard Institute (SLSI) |
Recommended only for this consignment. (As this is for Laboratory use only) |
|||||||||||||
12 |
23/02/2022 |
MD/626/02/2022 |
Programmer of Cardiac Resynchronization therapy defibrillator (Pacemaker) |
|
Biomed International (pvt) ltd |
Medtronic Europe S.a.r.l. - Switzerland |
For Purpose of Programming Implantable Pacemaker |
Recommended only for this consignment. (Because it is for the purpose of programming) |
|||||||||||||
13 |
23/02/2022 |
MD/621/02/2022 |
Battery Pack for Defibrillator |
|
Hemas Surgical & Diagnostics |
Nihon Kohden - Japan |
For Infectious Disease Hospital |
Recommended only for this consignment. Subject to submission of dossier. |
|||||||||||||
14 |
23/02/2022 |
MD/630/02/2022 |
Accessories for ultrasonic Aspiration System |
25 |
Medapp (pvt) ltd |
Soring GmbH - Germany |
|
Not recommended. Expedite the registration. |
|||||||||||||
15 |
23/02/2022 |
MD/632/02/2022 |
Reagents for Hematology Analyzer |
654 |
Hemas Surgical & Diagnostics |
Nihon Kohden - Japan |
For Office of Provincial Director of Health Services Wayamba |
Recommended only for this consignment. Subject to submission of dossier. |
|||||||||||||
16 |
23/02/2022 |
MD/633/02/2022 |
Reagents for Hematology Analyzer |
40 |
Hemas Surgical & Diagnostics |
Nihon Kohden - Japan |
For Office of Provincial Director of Health Services Wayamba |
Recommended only for this consignment. Subject to submission of dossier. |
|||||||||||||
17 |
23/02/2022 |
MD/634/02/2022 |
Spare Parts for Patient Monitors and Defibrillators |
52 |
Hemas Surgical & Diagnostics |
Nihon Kohden - Japan |
For Sri Jayawardhanapura General Hospital |
Recommended only for this consignment. Subject to submission of dossier. |
|||||||||||||
18 |
23/02/2022 |
MD/635/02/2022 |
Spare Parts for Hematology Analyzer |
97 |
Hemas Surgical & Diagnostics |
Nihon Kohden - Japan |
Sri Lanka Air Fource and Office of regional director of health services puttalam. |
Recommended only for this consignment. Subject to submission of dossier. |
|||||||||||||
19 |
23/02/2022 |
MD/636/02/2022 |
Spectra Optia Apheresis System |
18 |
Hemas Surgical & Diagnostics |
Terumo BCT Inc - USA |
For Blood Bank at University Hospital - KDU |
Not recommended. Expedite the registration. |
|||||||||||||
20 |
23/02/2022 |
MD/637/02/2022 |
Crystalvue Non-Mydriatic Auto Funds Camera (NFC 200) |
1 |
Philobiotics (Pvt) ltd |
Crystalvue Medical Corporation - Taiwan |
For Hospital Use (Mount Lotus Eye & ENT Hospital) |
Not recommended and advised to register the product. |
|||||||||||||
21 |
23/02/2022 |
MD/638/02/2022 |
OMNI gene ORAL (OM-501) / GUT (OMR-200) QIAamp DNA Micro biome Kit/Cry vials |
75 / 3 / 2200 |
Dr. Aruna Dharshan De Silva, Biomedical Laboratory 2, Department of Paraclinical Sciences, Faculty of Medicine, General Sri John Kotelawala Defence University (KDU) |
DNA Genotek Inc - Germany |
For KDU |
Recommended only for this consignment. (As this is for research purpose) |
|||||||||||||
22 |
23/02/2022 |
MD/639/02/2022 |
Bradford Assay Kit / Goat Polyclonal to human serum albumin / Human Lipocalin 2 Elisa Kit |
3 |
Avon Pharmo Chem (Pvt) ltd |
Ab cam PLC - United Kingdom |
For several University( For Research Purpose) |
Recommended. Subject to submit Ethic Review Committee Approval. |
|||||||||||||
23 |
23/02/2022 |
MD/640/02/2022 |
Surgical Instruments |
62 |
J.M. Wickramarachchi & Co. (pvt) ltd |
Rhein Enterprices (Pvt) ltd - Pakistan |
|
Not recommended and advised to register the product. |
|||||||||||||
24 |
23/02/2022 |
MD/642/02/202 |
College of American Pathologist (CAP) Proficiency Testing Program |
108 |
Lanka Hospital Diagnostics (pvt) ltd |
College of American Pathologist - USA |
For External Quality Assuarance Programme of the Lab |
Recommended only for this consignment. (CAP Accreditation) |
|||||||||||||
25 |
21/02/2022 |
MD/653/03/2022 |
Nucleic Acid Isolation System / PCR Analyzer |
1
1 |
Airport and Aviation Services (Sri Lanka) Limited |
|
For Hambantota and Anuradhapura General Hospitals |
Recommended. Subject to submit No Objection Letter from Local Agent. |
|||||||||||||
26 |
07/09/2021 |
- |
Oxygen Concentrator |
18 |
Emerchemie NB (Ceylon) Limited |
Foshan Care Medical Technology Co.ltd - China |
For Covid 19 Patient |
Recommended only for this consignment. (Based on the BMES Report) |
|||||||||||||
27 |
17/09/2021 |
MD/622/09/2021 |
Oxygen Concentrator |
|
Mohomed Shuraim Naushad |
Shenzhen Deda Health Co.ltd - China |
|
Not recommended and advised to re-export. Due to unsatisfactory Technical performance. |
|||||||||||||
28 |
11/02/2022 |
MD/583/02/2022 |
Rat Insulinoma Cell Line |
1 |
Dr. M.G.A.N. Perera, Faculty of Applied Sciences, Sabaragamuwa University of Sri Lanka |
Sigma Aldrich - United Kingdom |
For Research Purpose. WOR Committee held on 12/02/2022 and committee decision was Not Recommended. Advised to submit research protocol and Ethic committee Approval. |
Recommended only for this consignment. |
|||||||||||||
29 |
11/02/2022 |
MD/584/02/2022 |
Hep G2 Cell Line human |
1 |
Dr. M.G.A.N. Perera, Faculty of Applied Sciences, Sabaragamuwa University of Sri Lanka |
Sigma Aldrich - United Kingdom |
For Research Purpose. WOR Committee held on 12/02/2022 and committee decision was Not Recommended. Advised to submit research protocol and Ethic committee Approval. |
Recommended only for this consignment. |
|||||||||||||
30 |
07/03/2022 |
MD/654/03/2022 |
Pulmonary Function Test Device |
01 |
Tesla One (Pvt) ltd |
Ganshorn Medical Electronic GmbH - Germany |
Donation to IDH Hospital - Angoda |
Recommended only for this consignment. |
|||||||||||||
31 |
25/02/2022 |
MD/655/03/2022 |
Clinical Chemistry Analyzer, Reagents & Accessories & Spare Parts |
|
Analytical Instruments (pvt) ltd |
Thermo Fisher Scientific Oy - Finland |
For Sevaral Government Institutes |
Not recommended. Expedite the registration. |
|||||||||||||
32 |
23/02/2022 |
MD/625/02/2022 |
Table Mounted Retractor |
1 |
Gilead Innovations |
Mediflex Surgical Products - USA |
For Naional Hospital - Sri Lanka |
Not recommended and advised to register the product. |
|||||||||||||
33 |
11/03/2022 |
MD/658/03/2022 |
Lab Blender – 400ml (Brand : BagMixer – 400) |
54 |
Analytical Instruments |
Interscience – France. |
WHO Purchas Order. (For Food Laboratory at MRI) |
Recommended only for this consignment. (purchased by WHO for MRI) |
|||||||||||||
34 |
11/03/2022 |
MD/659/03/2022 |
TC 99m Generator, DTPA, DMSA, MDP, MA, MIBI, Nano Scan, HIDA, ECD |
26+5+1+20+3+6+2+1+6 |
Medical Supplies Division |
Ezacibasi-Monrol Nuclear Products Co - Turkey |
For NHSL. |
Recommended only for this consignment. |
|||||||||||||
35 |
11/03/2022 |
MD/660/03/2022 |
Evis Exera II Colonovideoscope. (CF-Q180AL0) |
|
Mediquipment Limited |
Olympus Co.ltd - Japan |
Repaired Items |
Recommended only for this consignment. (As this is sent earlier for repairs) |
|||||||||||||
36 |
11/03/2022 |
MD/661/03/2022 |
Evis Exera II Colonovideoscope. (CF-H180AL0) |
|
Mediquipment Limited |
Olympus Co.ltd - Japan |
Repaired Items |
Recommended only for this consignment. (As this is sent earlier for repairs) |
|||||||||||||
37 |
11/03/2022 |
MD/662/03/2022 |
Covid 19 Antigen Detecion Kits |
200,000 Kits |
Siba Holdings (Pvt) ltd |
M/S. Meril Diagnostics Pvt ltd - India. |
|
Not recommended and advised to register the product. |
|||||||||||||
38 |
09/01/2022 |
MD/577/02/2022 |
Immunohistochemistry Reagents |
|
A & M Suhada Enterprises (Pvt) Ltd |
Agilent Technologies Singapore (International) Pte Ltd - Singapore |
Appeal.
For University of Colombo.
Submitted to WOR Committee held on 12/02/2022 and committee decision was Not recommended and expedite the registration. |
Not recommended. Expedite the registration. Advised to submit Ethic Review Committee Approval. |
|||||||||||||
39 |
24/12/2021 |
MD/489/12/2021 |
Electric Saw |
1 |
Co-op Hospital - Eravur |
Wuhu Ruijin Instrument & Device Co.ltd - China |
Submitted to WOR Committee held on 08/01/2022 and committee decision was Not recommended and advised to register the product. |
Not recommended and advised to re-export. |
|||||||||||||
40 |
5/1/2022 |
MD/518/01/2022 |
Surgical Blades |
100,000 |
Hayleys Agro Biotech (Pvt) ltd |
|
For Sri Lanka Export Development Board. Submitted to WOR Committee held on 08/01/2022 and committee decision was Not Recommended. (Purchase from registered source) |
Not recommended and advised to register the product. |
|||||||||||||
12/03/2022 - S.P.C |
|||||||||||||||||||||
|
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Applicant |
Manufacturer/Supplier |
Reason for WOR |
WOR Committee Approval |
|||||||||||||
1 |
14/02/2022 |
MD/597/02/2022 |
Umbilical Catheter - Sterile |
7750 |
Medigrow International (Pvt) ltd |
Silmag La Medicina Evoluciona - Argentina |
LP/DHS/SUS/WW/23/017PL/2021, Date: 16/10/2020 |
Recommended Only for this consignment. Subject to submission of Application for registration. (Only one bidder was bid for this tender.) |
|||||||||||||
2 |
14/02/2022 |
MD/598/02/2022 |
Exchange Transfusion Set Complete in tary sterile |
200 |
Medigrow International (Pvt) ltd |
Palasticab S.A.K.L - Lebanon |
LP/DHS/S/WW/36/560AM/2020, Date: 18/06/2020 |
Recommended only for this consignment. (No registered sources.) |
|||||||||||||
3 |
14/02/2022 |
MD/599/02/2022 |
Peripherally Inserted Central Catheter (PICC) 28G/1.2 Fr - 30cm |
40 |
Medigrow International (Pvt) ltd |
Silmag La Medicina Evoluciona - Argentina |
LP/DHS/S/WW/36/560AM/2020, Date: 18/06/2020 |
Recommended only for this consignment. (No registered sources.) |
|||||||||||||
4 |
14/02/2022 |
MD/600/02/2022 |
EDTA Blood Collecting Tube, Vacuumed, Pet Tube 2ml |
2,580,000 |
Sethmedi International (pvt) ltd |
Ningbo Foymed Medical Instruments Co.ltd - China |
LP/DHS/L/WW/36/007CPW/2022, Date:30/11/2021 |
WOR Not recommended. Consider purchasing from a local manufacturer or register this supplier. |
|||||||||||||
5 |
18/02/2022 |
MD/594/02/2022 |
Hypodermic Needles |
|
Medisurge International |
JIangsu Kangyou Medical Instrument Co.ltd - China |
DHS/S/WW/26/88DC/21, Date:13/01/2021 , DHS/S/WW/26/24DC/21 |
WOR Not recommended and expedite the registration. |
|||||||||||||
6 |
22/02/2022 |
MD/608/02/2022 |
Retinoscope with Standard Accessories Battery Powder |
106 |
A. Baur & Co. (Pvt) ltd |
WelchAllyn Inc - USA |
LP/DHS/S/WW/114/552HP/21, Date: 15/11/2021 |
Recommended only for this consignment. Subject to submission of registration dossier. |
|||||||||||||
7 |
22/02/2022 |
MD/609/02/2022 |
Exchange Transfusion Set |
2250 |
TMI Solution (Pvt) ltd |
Vygon SA - France |
LP/DHS/S/WW/50/610AK/21, date: 22/12/2021 |
Recommended only for this consignment. Subject to submission of registration dossier. |
|||||||||||||
8 |
23/02/2022 |
MD/616/02/2022 |
Rabbit Complement for HLA typing |
100 |
Primecare Holdings (Pvt) ltd |
Bag Diagnostics - German |
SPC Tender DHS/L/WW/19/22 , date: 28/06/2021 |
Recommended only for this consignment. Subject to submission of registration dossier. |
|||||||||||||
9 |
23/02/2022 |
MD/620/02/2022 |
Disposable Central Venous Catheter set (Double Lumen) / Disposable Central Venous Catheter (single Lumen) |
3000 |
Meditechnology Holdings (pvt) ltd |
Guangdong Baihe Medical Technology - China |
SPC Tender DHS/S/WW/33/46KC/2021, date: 13/11/2020 |
Not recommended and expedite the registration. |
|||||||||||||
10 |
04/03/2022 |
MD/649/03/2022 |
Balanced Salt Solution (Brand: Rins BS) |
35000 |
Commercial Syndicate Medical (Pvt) ltd |
Ain Medicare Sdn Bhd - Malaysia |
DHS/PM/98/21 , date: 14/11/2020 |
Recommended only for this consignment. Subject to submission of registration dossier. |
|||||||||||||
09/04/2022 |
|||||||||||||||||||||
|
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Applicant |
Manufacturer/Supplier |
Reason for WOR |
WOR Committee Approval |
|||||||||||||
1 |
15/03/2022 |
MD/673/03/2022 |
Tempons (Marvel Lady) |
18720 |
Aravinds (pvt) ltd |
Hangzhou Xinxiang Industrial Co.ltd - China |
|
Recommended only for this consignment. (Not registered sources at present.) |
|||||||||||||
2 |
15/03/2022 |
MD/674/03/2022 |
Repaired Item. Spare parts and Accessories for Sterilizer. |
63 |
Mediquipment Limited |
Getinge Sterilization AB, Sweeden |
For Lanka Hospital PLC, Office of the Regional Director of Health Services- Jaffna, Ninewells Hospital (Pvt) ltd |
Recommended only for this consignment. |
|||||||||||||
3 |
15/03/2022 |
MD/675/03/2022 |
Repaired Item. Spare parts and Accessories for Sterilizer. |
23 |
Hemas Surgical & Diagnostics |
Nihon Kohden |
For Suwa Seriya Foundation |
Recommended only for this consignment. |
|||||||||||||
4 |
15/03/2022 |
MD/676/03/2022 |
Pharmacy Refrigerators (Model: HYC-290, HYC-310, YDS-6YS) |
3 |
Biomedica (Pvt) ltd |
Haier Biomedical Co.ltd - China |
For Eye Hospital Sri Lanka |
Recommended only for this consignment. |
|||||||||||||
5 |
24/03/2022 |
MD/688/03/2022 |
Continuous Renal Replacement Therapy Device |
1 |
Diligence Healthcare (Pvt) ltd |
Infomed SA - Switzerland |
For Regional Directorate of Health Services - Mannar |
Recommended. Issue the WOR after the local agent submits the correct clear request. |
|||||||||||||
6 |
24/03/2022 |
MD/689/03/2022 |
Biosafety Cabinets (Model: HR 1200-IIA2-S) |
1 |
Biomedica (Pvt) ltd |
Haier Biomedical Co.ltd - China |
For Sri Lanka Air Force Headquarters |
Not recommended and advised to register the product. Advised to SLAF to purchase from registered sources. |
|||||||||||||
7 |
30/03/2022 |
MD/690/04/2022 |
Premium plus GEEA/GIA/Endo GIA / VLOC 180 Etxation Device / Protack / Tasuture |
3 |
A. Baur & Co. (Pvt) ltd |
Covidie LLC - USA. |
For Several Hospitals Sri Lanka. (Kings Hospital Colombo, Hemas Capital Hospital Thalawathugoda, Asiri Hospital Galle, Apeksha Hospital Maharagama, Teaching Hodpital Karapitiya, Hemas Hospital Wattala.) |
Recommended only for this consignment. |
|||||||||||||
8 |
04/04/2022 |
MD/697/04/2022 |
Non-Stick Bipolar Coagulation Forceps |
20 |
Innomedsys International (Pvt) ltd |
Adeor Medical AG - Germany |
For Sri Lanka National Hospital |
Not recommended and Expedite the registration. |
|||||||||||||
9 |
04/04/2022 |
MD/699/04/2022 |
Resuscitator |
30 |
Premium International (pvt) ltd |
Medical Technology Transfer & Services Co.ltd (MTTS) - Vietnam |
Donation to the Perinatal Society of Sri Lanka. |
Recommended only for this consignment. Subject to initiate the product registration. |
|||||||||||||
10 |
04/04/2022 |
MD/700/04/2022 |
Ahmed Glaucoma Valve |
20 |
U&I Ceylon (Pvt) ltd |
New World Medical Inc - USA |
For National Eye Hospital, LRH and Privat Hospitals in Colombo. |
Not recommended. Advised to submit details to confirm the use of the product from 2015 at LRH and other hospitals. |
|||||||||||||
11 |
05/04/2022 |
MD/703/04/2022 |
HCG Urine Strip |
96000 |
A. Baur & Co. (Pvt) ltd |
HRunbio Biotech Co.ltd - China |
(Out of Stock) |
Not recommended and advised to register the product. |
|||||||||||||
12 |
05/04/2022 |
MD/704/04/2022 |
Repaired Item. Spare parts and Accessories for Sterilizer. |
5 |
Mediquipment Limited |
Geting Sterilization AB - Sweden |
Repaired Item (For Lanka Hospitals PLC) |
Recommended only for this consignment. |
|||||||||||||
13 |
05/04/2022 |
MD/705/04/2022 |
Repaired Item. Spare parts and Accessories for Sterilizer. |
|
Mediquipment Limited |
Olympus Co.ltd - Japan. |
Repaired Item (ForHemas Hospitals (pvt) ltd) |
Recommended only for this consignment. |
|||||||||||||
14 |
05/04/2022 |
MD/706/04/2022 |
Q Switch Nd-Yag Laser Tattoo Removal Machine (RL-C10) |
1 |
Jethawanarama Viharaya |
HK Renlang Electron Technology Co.ltd - China |
For monastery use only |
Not recommended and advised to register the product. |
|||||||||||||
15 |
05/04/2022 |
MD/707/04/2022 |
Demo Mirena Evo AG Sten Reloadable |
30 |
Hemas Pharmaceuticals (pvt) ltd |
Bayer Oy - Finland |
For Demonstration Purpose |
Recommended only for this consignment. |
|||||||||||||
16 |
05/04/2022 |
MD/708/04/2022 |
Syringe Filter Units, Sterile |
50 |
Atlas Populi (Pvt) ltd |
Merck KGaA - Germany |
For Testing Purpose. |
Product Categorization. (This item not used for medical purpose.) |
|||||||||||||
17 |
05/04/2022 |
MD/709/04/2022 |
Image & Report Management System with Standard Accessories & Spare Parts (Model: Clarus 500) (Brand: Zeiss) |
1 |
Dimo (Pvt) ltd |
Carl Zeiss Meditec Inc - Dublin (Legal manufacturer address change and informed NMRA on 02/11/2021) |
|
Recommended only for this consignment and Expedite the registration.
|
|||||||||||||
18 |
05/04/2022 |
MD/710/04/2022 |
Repaired Item. Video Colonoscopy System with Spare Parts & Standard Accessories |
2 |
Mediquipment Limited |
Olympus Medical System Corporation - Japan |
Repaired Item (For Lanka Hospital and Asiri Surgical Hospital) |
Recommended only for this consignment. |
|||||||||||||
19 |
06/04/2022 |
MD/711/04/2022 |
Xenon Light Source (Model: CLV-S40Pro) |
|
Mediquipment Limited |
Olympus Medical System Corporation - Japan |
Repaired Item (For National Hospital of Sri Lanka) |
Recommended only for this consignment. |
|||||||||||||
20 |
06/04/2022 |
MD/712/04/2022 |
Endoscopic Ultrasound Center (Model: EU-ME1) |
|
Mediquipment Limited |
Olympus Medical System Corporation - Japan |
Repaired Item (For National Hospital of Sri Lanka) |
Recommended only for this consignment. |
|||||||||||||
21 |
06/04/2022 |
MD/713/04/2022 |
Video System Center |
|
Mediquipment Limited |
Olympus Medical System Corporation - Japan |
Repaired Item (Teaching Hospital - Jaffna) |
Recommended only for this consignment. |
|||||||||||||
22 |
06/04/2022 |
MD/714/04/2022 |
Urology Telescope |
|
Mediquipment Limited |
Olympus Medical System Corporation - Japan |
Repaired Item (Sri Jayawardenapura General Hospital and Postgraduate Medical Training Center) |
Recommended only for this consignment. |
|||||||||||||
23 |
06/04/2022 |
MD/715/04/2022 |
Reagents PCR Machine |
3 |
Hayleys Lifesciences (pvt) ltd |
Care DX AB - Sweden |
|
Recommended only for this consignment. |
|||||||||||||
24 |
06/04/2022 |
MD/716/04/2022 |
Cryptococcus Latex Antigen Test Kits (Brand:Remel) |
5 |
Hemsons International |
Remel Inc - USA |
For MRI |
Recommended. Advised to submit NOL from Trivitron Nawakrama Medical Technologies (Pvt) ltd then issue WOR. |
|||||||||||||
25 |
05/04/2022 |
MD/719/04/2022 |
Artificial Limbs |
|
Dr. B. Panagamuwa, Meththa Rehabilitation Foundation |
The Meththa Foundation - UK |
Donation |
Recommended only for this consignment. |
|||||||||||||
26 |
07/04/2022 |
MD/722/04/2022 |
TC 99m Generator (12.5GBq), MDP, Nanocole |
26+260+12 |
Medical Supplies Division |
Ezacibasi-Monrol Nuclear Products Co- Turkey / Medi-Radiopharma Kft - Hungary |
Donation (For NMU, Apeksha Hospital) |
Recommended only for this consignment. |
|||||||||||||
27 |
06/04/2022 |
MD/723/04/2022 |
Air Cylinder |
|
SHM Shipcare (pvt) ltd |
|
Lifesaving Purpose. |
Not recommended and advised to register the product. |
|||||||||||||
28 |
15/03/2022 |
MD/720/04/2022 |
Medium 199-Hanks Balanced Salt (500ml Bottles) |
|
Analytical Instruments |
Thermo Fisher - USA |
For Lady Ridgway Hospital |
Recommended only for this consignment. |
|||||||||||||
29 |
24/12/2022 |
MD/529/01/2022 |
Wallace Catheters & Oocyte recovery set. |
285 |
A. Baur & Co.(Pvt) ltd |
Cooper Surgical Inc - USA |
For several Hospitals in Sri Lanka (Lanka Hospital PLC/ Nawaloka Hospitals PLC & Vindana Reproductive Health Centre) |
Recommended only for this consignment. |
|||||||||||||
30 |
23/02/2022 |
MD/625/02/2022 |
Table Mounted Retractor |
1 |
Gilead Innovations |
Mediflex Surgical Products - USA |
For National Hospital - Sri Lanka |
Not recommended and advised to register the product. |
|||||||||||||
31 |
08/04/2022 |
MD/725/04/2022 |
808nm Laser Hair Removal Machine |
36 |
Durdans Hospital |
Sus Advancing Technology Co.ltd - China |
For Hospital Use. |
Not recommended and advised to register the product. |
|||||||||||||
32 |
08/04/2022 |
MD/726/04/2022 |
TaqMan RNase P Instrument (ViiA 7 System) / 384 well Verification Plate, Pack of 1 kit and TaqMan RNase P Instrument (ViiA 7 System) 96 well Verification Plate, Pack of 1 Kit |
1 |
National Programme for Tuberculosis Control & Chest Diseases |
Fisher Healthcare UK Ltd - UK |
Donation to NPTCCD |
Recommended only for this consignment. |
|||||||||||||
33 |
05/04/2022 |
MD/724/04/2022 |
ELISA Kit |
|
University of Ruhuna |
Wuhan Huamei Biotech Co.ltd - China |
Donation |
Recommended. Advised to submit WOR Application, Invoice, Manufacturer details, Product Information. |
|||||||||||||
34 |
08/04/2022 |
MD/727/04/2022 |
Oxylog 3000 Ventilator |
2 |
District General Hospital - Matara |
- |
Donation |
Recommended only for this consignment. Advised to submit WOR Application, Invoice, Manufacturer details, Product Information. |
|||||||||||||
09/04/2022 - S.P.C |
|||||||||||||||||||||
|
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Applicant |
Manufacturer/Supplier |
Reason for WOR |
WOR Committee Approval |
|||||||||||||
1 |
22/03/2022 |
MD/677/03/2022 |
E.C.G. Recording Paper |
312,000 Rolls |
Emar Pharma (Pvt) ltd |
M/S Chhenna Corporation – India. |
LP/DHS/L/WW/97/109WAC/21, date: 12/10/2021 |
Recommended only for this consignment. |
|||||||||||||
2 |
24/03/2022 |
MD/694/04/2022 |
Capsular Tension Ring with fixtion arm, left, size 10mm - 12mm sterile / Iris Respositor, Titanium and others |
|
Safe Globes Lanka (pvt) ltd |
Plus Surgicals – Lolkata. |
LP/DHS/S/WW/101/652HP/21, date: 20/01/2022 , LP/DHS/S/WW/114/670HP/21, date: 11/02/2022 |
Recommended only for this consignment. |
|||||||||||||
3 |
22/03/2022 |
MD/678/03/2022 |
Blood Bank Reagents |
|
Primecare Holdings (Pvt) ltd |
ALBA Bioscience Limited - UK. |
DHS/L/WW/33/22 (Not attached SPC Indent) |
Not recommended and advised to register the product. |
|||||||||||||
4 |
27/10/2021 |
MD/318/11/2021 |
Ortho Phythalaldehyde Solution 0.55% w/v |
N/A |
L W Medicals |
M/s. Unilab Chemicals and Pharmaceuticals (pvt) ltd - India |
DHS/RP/407/2020 |
Not recommended and advised to register the product. |
|||||||||||||
Agenda for Waiver of Registration Committee - Device 07/05/2022 |
|||||||||||||||||||||
|
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Applicant |
Manufacturer/Supplier |
Reason for WOR |
WOR Committee Approval |
|||||||||||||
1 |
21/04/2022 |
MD/732/04/2022 |
Rehabilitatior Equipment |
|
MJF Charitable Foundation |
Wheelstoheal - UK |
Donation to Lady Ridgway Hospital |
Recommended with condition. Subject to submission of distribution list and requested letters from receivers on items and quantity. |
|||||||||||||
2 |
21/04/2022 |
MD/734/04/2022 |
Viral Transport Medium Kit |
1000 |
Siba Holdings |
M/s Meril Diagnostics (Pvt) ltd - India |
For Sri Lanka Market |
Not recommended and Expedite the registration. |
|||||||||||||
3 |
21/04/2022 |
MD/735/04/2022 |
Tencell Cuvettes for Clinical Chemistry Analyzer, Reagents & Accessories & Spare Parts (Indiko) |
150+50 |
Analytical Instruments |
Thermo Fisher Scientific Oy - Finland |
For Sirimavo Bandaranayeke Specialized Children's Hospital - Peradeniya and RDHS - Jaffna. |
Not recommended and Expedite the registration. |
|||||||||||||
4 |
25/04/2022 |
MD/748/04/2022 |
Oxygen Generator Plant |
2 |
Delmege Forsyth& Co.ltd |
Meditech TechnologyCorp.ltd-China |
Ministry of Health Tender |
Currently NMRA not regulating Oxygen Generator Plant. If tender is awarded after BMES evaluation to issue NOL. |
|||||||||||||
5 |
25/04/2022 |
MD/749/04/2022 |
Microtome Blade |
21 CV |
Analytical Instruments |
Epredia Netherland B.V - Netherlands |
For National Hospital in Sri Lanka |
Not recommended and advised to register the product. |
|||||||||||||
6 |
27/04/2022 |
MD/651/04/2022 |
Mobile X-Ray System Mobirex i9 / CT Scanner TSX-305A |
1 + 1 |
Mediquipment Limited |
Canon Medical Systems Corporation - Japan |
For Suwasevana Hospitals (Pvt) ltd |
Not recommended and advised to register the product. |
|||||||||||||
7 |
04/05/2022 |
MD/757/05/2022 |
Male Condoms (53mm), Femail Condoms (143mm) , Lubricants |
5350+10+700 |
National STD/AIDS Control Programme |
Cupid Ltd - India |
Donation |
Recommended only for this consignment. |
|||||||||||||
8 |
08/04/2022 |
MD/725/04/2022 |
808nm Laser Hair Removal Machine |
36 |
Durdans Hospital |
Sus Advancing Technology Co.ltd - China |
For Hospital Use. |
Not recommended and advised to register the product. (No single user of the product. For hospital multiple user) |
|||||||||||||
9 |
09/01/2022 |
MD/577/02/2022 |
Immunohistochemistry Reagents |
42 |
A & M Suhada Enterprises (Pvt) Ltd |
Agilent Technologies Singapore (International) Pte Ltd - Singapore |
For University of Colombo.
|
Not recommended. Need to submit the clinical clearance letter for research purpose. |
|||||||||||||
07/05/2022 - S.P.C |
|||||||||||||||||||||
|
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Applicant |
Manufacturer/Supplier |
Reason for WOR |
WOR Committee Approval |
|||||||||||||
1 |
04/05/2022 |
MD/756/05/2022 |
Stainless Steel Needle Suture (Brand: Stelus) |
10,100 |
Premier Healthcare (Pvt) ltd |
Lotus Surgical (Pvt) ltd - India |
SPC Tender DHS/S/WW/104/100RA/21, dated: 12/01/2021 |
Recommended with condition. Subject to submission of new dossier. |
|||||||||||||
11/06/2022 |
|||||||||||||||||||||
|
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
WOR Committee Approval |
||||||||||||
1 |
20/05/2022 |
MD/770/05/2022 |
Pharmacy Refrigerators |
5 |
HRP-003-Biomedica-2022 |
Biomedica (Pvt) ltd |
Haier Biomedical Co.ltd - China |
For RDHS - Anuradhapura |
Recommended only for this consignment and advised to submit dossier for registration. |
||||||||||||
2 |
09/05/2022 |
MD/784/05/2022 |
Hyperbaric Oxygen Therapy |
1 |
RE2022-026P, date: 27/04/2022 |
Analytical Instruments |
Haux-Life-Support GmbH - Germany |
For Ministry of Defence |
Not recommended and advised to register the product. Apply for registration to expedite. |
||||||||||||
3 |
20/05/2022 |
MD/785/05/2022 |
Surgical Items. 1. Neoprene Hinge Knee Support NP-05. 2. Thumb Support WS - 06 |
|
S/C/004/2022, Date: 19/05/2022 |
Dr. L.K.D. Chandana R. Karunathilaka, Musculoskeletal Sciences Department, University Hospital- KDU Local Agent: Avenier Pharma (Pvt) ltd) |
Manufacturer - Aadhar Medicare Pvt ltd - India Supplier - Plus Medical Devices India (P) ltd - India |
For KDU |
Not recommended and expedite the registration. (Email - P7) |
||||||||||||
4 |
24/05/2022 |
MD/787/05/2022 |
Sodium Bicarbonate Powder for Hemodial ysis (Bibag 5008) |
15000 Pce |
4503066044, date: 19/05/2022 |
Fresenius Medical Care |
Fresenius Medical Care - Germany |
For haemodialysis treatments procedure of patients with chronic kindly disease. |
Recommended only for this consignment. Subject to submission of dossier. |
||||||||||||
5 |
03/06/2022 |
MD/798/06/2022 |
Gel Filled Textured Mammery Implant |
110 Packs |
0003-009012, date: 22/03/2022 |
CIC Holdings PLC |
Biosil Limited - UK |
|
Recommended only for this consignment. Advised to submit for registration. |
||||||||||||
6 |
27/05/2022 |
MD/799/06/2022 |
1 Unit of Aqua B Plus 1000 with standard Accessories |
|
INV/SP/356/05/22, date: 27/05/2022 |
Fresenius Medical Care |
Vivonic GmbH - Germany for Fresenius Medical Care AG & Co KGaA - Germany. |
Re-Export |
Pending Decision. Advised to submit a letter from the parent company for authorization to re-export. |
||||||||||||
7 |
06/06/2022 |
MD/811/06/2021 |
College of American Pathologist (CAP) Proficiency Testing Program |
As per the invoice |
384838 (CAP:902147901) |
Lanka Hospital Diagnostics (Pvt) ltd |
College of American Pathologist - USA |
For CAP Programme |
Recommended only for this consignment. |
||||||||||||
8 |
06/06/0202 |
MD/812/06/2022 |
Next Generation Sequencing Reagents |
As per the invoice |
73912698SO, date: 18/05/2022 |
Genelabs Medical (pvt) ltd |
Life technologies Holdings Pte Ltd - Singapore. |
For KDU |
Recommended. Issue WOR after obtaining NOL from Analytical Instrument. |
||||||||||||
9 |
06/06/0202 |
MD/814/06/2022 |
Reagents for Hematology Analyzer |
23 |
10025701, date: 15/04/2022 |
Hemas Surgical & Diagnostics |
Nihon Kohden - Japan |
For Sri Lanka Air Force Headquarters |
Recommended only for this consignment. Advised to submit file for registration. |
||||||||||||
10 |
06/06/0202 |
MD/816/06/2022 |
Cold disinfection for Haemodialysis Machines |
50 |
777634582, date: 22/12/2021 |
Fresenius Medical Care |
Fresenius Medical Care AG & Co. - Germany |
For haemodialysis treatments procedure of patients with chronic kindly disease. |
Not recommended. Expedite registration process after submission of sample. |
||||||||||||
11 |
08/04/2022 |
MD/725/04/2022 |
808nm Laser Hair Removal Machine |
01 |
PI22031663, date: 16/03/2022 |
Durdans Hospital |
Sus Advancing Technology Co.ltd - China |
For Hospital Use. |
Not recommended and advised to register the product or purchase registered product. |
||||||||||||
11/06/2022 - S.P.C |
|||||||||||||||||||||
|
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Invoice / Tender Number |
Applicant |
Manufacturer/ Supplier |
Reason for WOR |
WOR Committee Approval |
||||||||||||
1 |
23/05/2022 |
MD/786/05/2022 |
Spinal Pillow (Gillespie Type) |
5 |
DHS/SUS/WW/122/22, date:08/09/2021 |
Medapp (Pvt) ltd |
Ms. Zhangjiagang Huaxin Medical - China |
SPC Order |
Not recommended and advised to register the product. |
||||||||||||
2 |
27/05/2022 |
MD/800/06/2022 |
Mini Caps |
180,000 |
DHS/RSS/RQ/24/22 date: 22/04/2022 |
Kish International (Pvt) ltd |
ST. Stone Medical Devices (Pvt) ltd - India |
SPC Tender |
Not recommended. Refer to college of nephrology to expedite the registration. (Email - P9) |
||||||||||||
3 |
27/05/2022 |
MD/802/06/2022 |
Riboflavin Solution for Control Cross-Linking (CXL) |
400 |
DHS/P/WW/324/22, date: 09/11/2021 |
Lenstech Innovations (Pvt) ltd |
Ophthalmica (Pty) Ltd - South Korea |
SPC Tender (No SPC Tender Document, ISO, EC, and Free Sale Certificates) |
Not coming Under NMRA. Issue Product Categorization. |
||||||||||||
4 |
27/05/2022 |
MD/803/06/2022 |
Rongeurs (Surgical Instruments) (Brand: Aesculap) |
18 |
231271773, date: 18/01/2021 |
B Braun Lanka (pvt) ltd |
Aesculap AG, Am Aesculap - Germany |
SPC Tender (No SPC Tender Document, ISO, EC, and Free Sale Certificates) |
Recommended only for this consignment. |
||||||||||||
5 |
27/05/2022 |
MD/804/06/2022 |
Dental Excavator |
643 |
DHS/S/WW/106/1092MT/20, date: 11/11/2021 |
B Braun Lanka (pvt) ltd |
Aesculap AG, Am Aesculap - Germany |
SPC Tender (No ISO, EC, and Free Sale Certificates) |
Not recommended. Expedite the registration. (Email - P33) |
||||||||||||
6 |
27/05/2022 |
MD/805/06/2022 |
Rongeurs (Surgical Instruments) (Brand: Aesculap) |
2 |
231446977, date: 05/01/2022 |
B Braun Lanka (pvt) ltd |
Aesculap AG, Am Aesculap - Germany |
SPC Tender (No SPC Tender Document, ISO, EC, and Free Sale Certificates) |
Recommended only for this consignment. |
||||||||||||
7 |
27/05/2022 |
MD/806/06/2022 |
Rongeurs (Surgical Instruments) (Brand: Aesculap) |
3 |
231138897, date: 13/03/2020 |
B Braun Lanka (pvt) ltd |
Aesculap AG, Am Aesculap - Germany |
SPC Tender (No SPC Tender Document, ISO, EC, and Free Sale Certificates) |
Recommended only for this consignment. |
||||||||||||
8 |
27/05/2022 |
MD/807/06/2022 |
Sponge and Dressing Forceps (Brand: Aesculap) |
2 |
DHS/SUS/WW/26/195KM/21, date: 28/04/2021 |
B Braun Lanka (pvt) ltd |
Aesculap AG, Am Aesculap - Germany |
SPC Tender (No ISO, EC, and Free Sale Certificates) |
Not recommended. Expedite the registration. |
||||||||||||
9 |
27/05/2022 |
MD/808/06/2022 |
Dental Instruments (Dental Excavater) |
19 |
231013411, date: 29/07/2019 |
B Braun Lanka (pvt) ltd |
Aesculap AG, Am Aesculap - Germany |
SPC Tender (No SPC Tender Document, ISO, EC, and Free Sale Certificates) |
Not recommended. Expedite the registration. (Email - P33) |
||||||||||||
10 |
06/06/2022 |
MD/815/06/2022 |
Dental Probes |
938 |
DHS/RS/RQ/108/20 date; 24/02/2021 |
Rivomed Holdings (pvt) ltd |
Snaa Industries - pakistan |
SPC Tender |
Not recommended and advised to register the product. Advised to NOL from Indro (Pvt) ltd. |
||||||||||||
11 |
01/06/2022 |
MD/801/06/2022 |
Trutone Emote Electrictrolarynx Kit |
DHS/S/WW/81/528JT/20, date: 05/11/2022 |
Dilmark Medicare (Pvt) ltd |
Atos Medical - Sweden |
Appeal - SPC Tender |
Not recommended. Expedite the registration. (P9 - email) |
|||||||||||||
12 |
04/03/2022 |
MD/649/03/2022 |
Balanced Salt Solution (Brand: Rins BS) |
35000 |
DHS/PM/98/21, date: 14/11/2020 |
Commercial Syndicate Medical (Pvt) ltd |
Ain Medicare Sdn Bhd - Malaysia |
SPC Tender DHS/PM/98/21, date: 14/11/2020 |
Recommended only for this consignment. Subject to submit for registration within 90 days. |
||||||||||||
Ser. No. | Item | Invoice No. | Quantity | Applicant | Supplier | Status |
1 | Infrared Thermometer | 8158135101 | 50 | Mr. Asanka Gajaweera | Yin Yu Tian Technology Co., Ltd, China. | ISSUED |
2 | Infrared Thermometer | 7420951532 | 1 | DHL Global Forwarding Lanka PVT.LTD | Yin Yu Tian Technology Co., Ltd, China. | ISSUED |
3 | Infrared Thermometer | PTS-20-0420-01R | 20 | Samson Rubber products Pvt. Ltd | AViTA Corporation., Taiwan. | ISSUED |
4 | Infrared Thermometer | 3081827792 | 5 | Nature’s Beauty Creations Ltd | A & D Company Ltd., Japan. | ISSUED |
5 | Infrared Thermometer | HS20200323E | 500 | Premium International (Pvt) Ltd | Contec Medical Systems Co. Ltd, China. | ISSUED |
6 | Infrared Thermometer | MM20032005 | 100 | TMI Solutions (Pvt) Limited | Putian King Baby care Electronic Co., Ltd., China. | ISSUED |
7 | Infrared Thermometers | 20KTHW007 Dated 24th April 2020 USD 1728.00 |
96 | Wasana Udyoga Bombuwalage | Zhegiang Mondial Electronic Technology Co., Ltd. China | ISSUED |
8 | Infrared Thermometers | 20200429CM8 Dated 20th April 2020 USD 2000.00 |
500 | Cayenne International (Pvt.) Limited | Shenzhen LeZhongxing Technology Co., Ltd., China | ISSUED 11.05.2020 |
9 | Infrared Thermometers | TW20200511-003 | 750 | A Plus Connects Pvt. Ltd | Chonngqing Guiguzi Medical Device Technology Co., Ltd. China. | 29.05.20 |
dated 11th May 2020 | ||||||
USD 21,000.00 | ||||||
10 | Infrared Thermometers | HIL20200403001 | 1000 | Abans Plc | ShenZhen Sense Time Technology Co., Ltd., Hong Kong | 27.05.20 |
dated 03th April 2020 | ||||||
USD 36500.00 | ||||||
11 | Automated Thermal Imaging System | TT_0004 | 3 | Abans Plc | ShenZhen Sense Time Technology Co., Ltd., Hong Kong | 27.05.20 |
dated 20th March 2020 | ||||||
USD 34500.00 | ||||||
12 | Infrared Thermometers | ENV2005 | 3 | Abans Plc | Hunan Honggao Electronic Technology Co., Ltd., China | 30.05.20 |
dated 26th May 2020 | ||||||
USD 81.00 | ||||||
13 | Infrared Thermometer | BBLY-106 | 4680 | Akbar Pharmaceutical Pvt., Ltd. | Yiwu Babyly Medical Device Co., Ltd., China | 27.05.20 |
dated 04th May 2020 | ||||||
USD 163800.00 | ||||||
14 | Infrared Thermometer | 20200505 | 250 | AYU Ventures Pvt. Ltd | Hebei Evidence –Based Medical Technology Co. Ltd., China | |
dated 5th May 2020 | ||||||
USD 6923.00 | ||||||
15 | Infrared Thermometer | EWQSI200200328BH dated 26th April 20 | 500 | Biovest Healthcare Pvt., Ltd | Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. China | 27.05.20 |
USD 16700.00 | ||||||
16 | Infrared Thermometer | 20KTHW007 | 96 | Wasana Udyoga Bombuwalage | Zhegiang Mondial Electronic Technology Co., Ltd. China | 10.05.20 |
dated 24th April 2020 | ||||||
USD 1728.00 | ||||||
17 | Infrared Thermometer | CCC-LK-001, CCC-LK-003, CCC-LK-004, CCC-LK-005, dated 23rd March 20 | 8 | China National Cable Engineering Corporation | CHTC Jiahua Nonwoven Co., Ltd. China | 19.05.20 |
18 | Infrared Thermometer | 20-04565 | 500 | Certis Lanka Technology & Consultancy (Pvt) Limited | Harbin Xiande Technology Development Co. Ltd, China | 14.05.20 |
dated 28th April 2020 | ||||||
15345 | ||||||
19 | Infrared Thermometer | CETC/ACCESS/20200429 dated 29th April 2020 | 600 | Access international (Pvt) Ltd | CETC International Co., Ltd., China | 26.05.20 |
USD 33000.00 | ||||||
20 | Infrared Thermometer | FOC28850/2020 | 800 | Chamathkar Holdings Pvt Ltd | Zhang ZhouXin Tian Jiang Medical Equipment Co., Ltd. | 21.05.20 |
dated 25th March 2020 | China | |||||
USD 4450.00 | ||||||
21 | Infrared Thermometer | 40420136 | 150 | CMN Distributors Lanka Pvt. Ltd | Yobekan Medical Equipment Co., Ltd. China | 26.05.20 |
dated 30th April 2020 | ||||||
USD 4800.00 | ||||||
22 | Infrared Thermometer | NAK0420UPS1094 | 885 | D K Holdings | Guizhou Teakang Electronics Co., Ltd. China | 13.05.20 |
dated 29th April 2020 | ||||||
USD 4485.00 | ||||||
23 | Infrared Thermometer | ANX20200 427/ 03RA dated 27th April 2020 | 100 | Deem Manufactures | Putian Joko Electronic Co. Ltd, China | 22.05.20 |
USD 2500.00 | ||||||
24 | Infrared Thermometer | BF20200428IL0033 dated 28th April 2020 | 240 | EWIS Colombo Limited | Shenzhen Jufukang Electronic Co., Ltd., China | 26.05.20 |
USD 5811.00 | ||||||
25 | Infrared Thermometer | 28th April 2020 | 550 | Electronic IQ (Pvt) Limited | Jiang Xi Jeavox Co., Ltd. China | 21.05.20 |
USD 16225.00 | ||||||
26 | Infrared Thermometer | CIURLPI200427 29.04.2020 | 25200 | Digital Cells (Pvt) Ltd | Hunan Honggao Electronic Technology Co. Ltd, China | 12.05.20 |
CIURLPI200428 29.04.2020 | ||||||
CIURLPI2004291 30.04.2020 | ||||||
CIURLPI2004292 30.04.2020 | ||||||
CIURLPI200504 05.05.2020 | ||||||
USD 225700.00 | ||||||
27 | Infrared Thermometer | ENH/PI/2020/2003 dated 04th May 2020 | 680 | Envision Holdings International Pvt Ltd | Longnan Ren Zhong Medical Equipment Co., Ltd. China | 10.05.20 |
USD 8160.00 | ||||||
28 | Infrared Thermometer | K2020/067 | 1000 | Evercare Trading Company | Shenzhen Zhengkang Technology Co. Ltd, China | 13.05.20 |
dated 27th April 2020 | ||||||
USD 5650.00 | ||||||
29 | Infrared Thermometer | USD 24000.00 | 2000 | Fine Care Pharmaceuticals (Pvt) Ltd | Hangzhou Universal Electronic Company, China | 30.05.20 |
CFL-NW -2020-5- 17-001 dated 17th May 2020 | ||||||
30 | Infrared Thermometer | 2020FSR103 | 500 | Fine Surgicals | Wenzhou Yosun Medical Technology Co Ltd, China | 28.05.20 |
dated 13th May 2020 | ||||||
USD 10930.00 | ||||||
31 | Infrared Thermometer | FCHS20200507 | 900 | Future Need | Huizhou Xiaoou Technology Co., Ltd., China | 12.05.20 |
dated 05th March 2020 | ||||||
USD 9613.00 | ||||||
32 | Infrared Thermometer | FCHS20200508 | 1000 | Future Need | Huizhou Xiaoou Technology Co., Ltd., China | 12.05.20 |
dated 16th March 2020 | ||||||
10253 | ||||||
33 | Infrared Thermometer | KAY20200429 | 1000 | Gene Diagnostics | Hunan Honggao Electronic Technology Co., Ltd. China | 26.05.20 |
dated 13th May 2020 | ||||||
USD 27967.00 | ||||||
34 | Infrared Thermometer | EWQLK20200504GS dated 04th May 2020 | 1750 | George Steuart Health (Pvt) Ltd | Lepu Medical Technology, (Beijing) Co., Ltd. China | 14.05.20 |
USD 49875.00 | ||||||
35 | Infrared Thermometer | SJW-K20200420001 dated 20th April 2020 | 215 | Globe express International Pvt. Ltd | ShenZhen Changkun Technology Co. Ltd. China | 26.05.20 |
USD 2580.00 | ||||||
36 | Infrared Thermometer | 10313052020 | 240 | Helicon Pvt Ltd. | GuangDong Jaki Technology & Eduction Co Ltd, China. | 28.05.20 |
dated 09th May 2020 | ||||||
USD 5050.00 | ||||||
37 | Infrared Thermometer | CS20200514I | 1000 | Advanced Digital Technology | Hunan JRT Medical Devices Co., Ltd. China | 30.05.20 |
dated 14th May 2020 | ||||||
USD 14500.00 | ||||||
38 | Infrared Thermometer | ND202050803 | 800 | Himale Trading | Hunan Phicon Biotech Co Ltd. China | 22.05.20 |
dated 15th May 2020 | ||||||
USD 7310.00 | ||||||
39 | Infrared Thermometer | ENH/PI/2020/2004 dated 04th May 2020 | 120 | HMT international | Longnan Ren Zhong Medical Equipment Co., Ltd. China | 10.05.20 |
USD 1800.00 | ||||||
40 | Infrared Thermometer | MR200518-HMT01 dated 18-May-2020 | 280 | H M T International Ltd | Longnan RenZhong Medical Equipment Co., Ltd. China | 23.05.20 |
USD 3360.00 | ||||||
41 | Infrared Thermometer | 2020-27/04/DRKK01a dated 8th May 2020 | 1000 | Innogen Lanka (Pvt) Ltd | Shenzhen EP Intelligent Technology Co. Ltd., China | 29.05.20 |
USD 32000.00 | ||||||
42 | Infrared Thermometer | 2020-12/05/DRKK01a dated 13th May 2020 | 1000 | Innogen Lanka (Pvt) Ltd | Shenzhen EP Intelligent Technology Co. Ltd., China | 29.05.20 |
USD 32000.00 | ||||||
43 | Infrared Thermometer | GS20200508 | 576 | Mr. KACS Rodrigo | Ganzhou Manchang Medical Equipment Co.,Ltd. China | 29.05.20 |
dated 8th May 2020 | ||||||
USD 25483.00 | ||||||
44 | Infrared Thermometer | 2020032401 | 1 | JVSN Trading & Engineering Co Pvt. Ltd | Winner Medical Co. Ltd., China | 10.05.20 |
dated 24th March 2020 | ||||||
USD 29.00 | ||||||
45 | Infrared Thermometer | DY20200508019 dated 8th May 2020 | 100 | Keygen Security Pvt Ltd | Dytech Technology Ltd., Hong Kong | 28.05.20 |
USD 2600.00 | ||||||
46 | Infrared Thermometer | VM20200502 | 25 | Laboratory Equipment Co Pvt Ltd | Jiangxi Aicare Medical Technology Co Ltd, China | 30.05.20 |
dated 2nd May 2020 | ||||||
USD 875.00 | ||||||
47 | Infrared Thermometer | HWZ20D127-001A | 250 | MAT International Trading Co. Pvt. Ltd | Xiamen Jizhi Technology Co. Ltd., China | 16.05.20 |
dated 30th April 2020 | ||||||
USD 6750.00 | ||||||
48 | Infrared Thermometer | HWZ20D127-002 | 500 | MAT International Trading Co. Pvt. Ltd | Xiamen Jizhi Technology Co. Ltd., China | 30.05.20 |
dated 11th May 2020 | ||||||
USD 13500.00 | ||||||
49 | Infrared Thermometer | SYI090520X | 2000 | Max Lanka Trading Co. Pvt. Ltd | Yichun Kang Guan Zhi Xin Medical Technology Co. Ltd., China | 16.05.20 |
dated 07th May 2020 | ||||||
USD 34000.00 | ||||||
50 | Infrared Thermometer | GT2020505012 | 280 | Maxwell Healthcare (Pvt) Ltd | Guangdong Genial Technology Co. Ltd, China | 23.05.20 |
dated 7-May-2020 | ||||||
USD 7000.00 | ||||||
51 | Infrared Thermometer | LT20200427SYPLK | 500 | Med Solutions Pvt., Ltd. | ShenZhen Zhengkang Technology Co., Ltd. China | 30.05.20 |
dated 27th April 2020 | ||||||
USD 12800.00 | ||||||
52 | Infrared Thermometer | DK200503 | 1000 | Medex Holding (Pvt) Limited | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. China | 21.05.20 |
dated 12th May 2020 | ||||||
USD 21000.00 | ||||||
53 | Infrared Thermometer | VM20200428 | 2000 | Meditechnology Holdings (Pvt) Ltd | Jiangxi AICARE Medical Technology Co. Ltd, China | 12.05.20 |
dated 28th April 2020 | ||||||
USD 90000.00 | ||||||
54 | Infrared Thermometer | PI#20200505-Mega-P1- dated 13th May 2020 | 1000 | Mega Meditech Pvt Ltd | TaiDoc Technology Corporation, Taiwan | 30.05.20 |
USD 12000.00 | ||||||
55 | Infrared Thermometer | AK-ECPL-1038/MORICH dated 28th April 2020 | 120 | Morich Trading (Pvt.) Ltd | Guangzhou Berrcom Medical Device Co., Ltd. China | 10.05.20 |
USD 1800.00 | ||||||
56 | Non- contact Infrared Thermometer (Model: BZ- R6) | Commercial invoice No: SI- 178 | 1000 | San Trading Enterprises (Pvt) Ltd, | Henan Bingzun Industrial Co. Ltd, China for ENG Exports Ltd, Hong Kong for | Issued |
57 | Medical Infrared Forehead Thermometer (Model RT- 105) | 300 pcs Proforma Invoice No: G202004 -01L | 11350 USD | Trade first (Pvt) Ltd, | Dongguan Rongfeng Medical Co Ltd, China for Jinan Grace Industry Co. Ltd, China | Issued |
58 | Infra red Thermometers | INVOCIE NO.:BIOBASE20200416SR of 16th April 2020 | 50 | Enviroequip pvt ltd no 87, old Kottawa road mirihana nugegoda | from Biobase Biodustry (Shandong) Co., Ltd., Shandong Biobase Industry Park, crossed between Mingbu Road and East Jingshi Road, Mingshui Economic Development Zone, Shandong Province, China. | Issued |
59 | Infrared Thermometers | commercial invoice NO. LY19-0318C08 of 23 rd March 2020 | 200 | Enviroequip pvt ltd no 87, old Kottawa road mirihana nugegoda | LIYI Environmental Technology Co.,Ltd, 02-03, 6/F, Gaosheng Technology Park,Nancheng District , Dongguan , Guangdong, China (LIYI GROUP (HONGKONG) CO.,LTD,) . | ISSUED |
60 | IR Thermometers | Invoice No HIL20200619001 of dated 19th May 2020 | 3045 | Abans PLC, 498, Galle road, Colombo 03, Sri Lanka | Heier International (HK) Limited, Room 1908, Habour center25, Harbour road, Wanchai, Hong Kong, The product is manufactured by Shenzhen Jumper Medical Equipment Co. Ltd, D Building, No 71, Xiantian road, Fuyong street, Baoan, Shenzhen, Guangdong, China. | issued |
61 | IR Thermometer | Invoices: EWQLK20200325GS | George Steuart Health | Lepu Medical Technology (Beijing)Co.Ltd | ISSUED | |
62 | Thermometer | LK/0551 | 5 | LTL Transformers (Pvt) Ltd | Ningbo Winner Technology Co. Ltd | ISSUED |
63 | IR Thermometer | 1,000 | Worldwide Trading Lanka(pvt) Ltd | Rubine ChinaInternal (Private) Limited, | ||
64 | IR Thermometer | 100 | Lanerolle BSA | M/s. Evangel | ||
International Machinery Limited, | ||||||
65 | IR Thermometer | 1,000 | E-W Information System Ltd | Hongkong ChoiceElectronics Co. Limited, | ||
66 | Infared Thermometers & Face Mask | 4932129 | Emerchemie NB ( Ceylon) Ltd | Tesma Insaat Dis Ticaret Sanyayi Limited Sirketi | Issued | |
67 | IR Thermometer | EWQLK20200417GS EWQLK20200423GS |
1400 1750 |
George Steuart Health (Pvt) Ltd No. 7E,Post Masters Place, Off Templers Road, Mount Lavinia, | Lepu Medical Technology (Beijing) Co, Ltd. Building 3, No. 37 Chao Qian Road,Changping Tech. Zone,Beijing, China 100176. | Issued |
68 | Infrared Thermometers | United Nations World Food Programme | Jiangxi Aicare Medical Technology Co. Ltd - China | Recommended only for this consignment | ||
69 | Infrared Thermal Imaging Device. | Excel Trading International (Pvt) Ltd. | Shenzhan Kuang -Chi Space Technology Co.Ltd | Issue WOR only for this consignment and advised to register the product in future importation | ||
70 | Infrared Thermometers & Disposable Face Mask | Heineken Lanka Ltd | Heineken Asia Pacific Pte. Ltd - Singapore | Recommended only for these consignment | ||
71 | Infrared Forehead Thermometer | CIC Vetcare (Pvt) Ltd | Shanghai Joylab Medical Instruments Co. Ltd - China | Recommended only for these consignment | ||
72 | Infrared Thermometers | Dimuthu Tex | Hunan Tuogao Medical Technology Co.Ltd - China | Recommended only for these consignment | ||
73 | Infrared Forehead Thermometer | SS20200519 (USD 3200) | 200 | S & S Trading | HongKong Greaty Industry Co., Limited, China | issued |
74 | Infrared Thermometers | Invoice No. ZZDF-20200509-03 dated 9th May 2020 USD 24776.00 | 1008 | TECHNIP Engineering Company | Zhejiang Mondial Electronic Technology Ltd. China | 26.06.20 |
75 | Infrared Thermometer | Invoice No. 439043060 dated 20th April 2020 | 50 | ABC Trade & Investment Pvt Ltd | Shenzhen Xinhonggjing Photoelectric Technology Co. Ltd. China | 30.06.20 |
USD 1970.00 | ||||||
76 | Infrared Thermometers | Invoice No. K2020/079 dated 11th May 2020 | 1000 | Evercare Trading Company | Shenzhen Zhengkang Technology Co. Ltd, China | 07.06.20 |
USD 5650.00 | ||||||
77 | Infrared Thermometer | Invoice No. STL 20019 dated 14th May 2020 | 650 | Evercare Trading Company | Guangzhou PHICON Biotech Co., Ltd., China | 10.06.20 |
USD 2650.00 | ||||||
78 | Infrared Thermometer | invoice No. 200428-SK dated 28th April 2020 | 520 | HealthTrust Pharmaceuticals (Pvt) Ltd | Xiamen Ants Bro Technology Co., Ltd., China | 26.06.20 |
USD 12480.00 | ||||||
79 | Infrared Thermometers | Invoice No. 517919 dated 13th May 2020 | 155 | A.Baur & Company Ltd | Exergen Corporation, USA | 03.07.20 |
USD 14766.00 | ||||||
80 | Infrared Thermometers | Invoice No. SO-20000541 dated 09th June 2020 | 500 | A.Baur & Company Ltd. | Kunshan Radiant Innovation Co Ltd. Japan | 15.07.20 |
USD 11500.00 | ||||||
81 | Infrared Thermometers | Invoice No. XTD 002 dated 18th May 2020. | 180 | EVERGREEN Lighting and Electrical Lanka (Pvt) Ltd | Harbin Xiande Technology Development Co. Ltd, China | 15.07.20 |
USD 1928.00 | ||||||
82 | Infrared Thermometers | Invoice No. 9409611 | 100 | Morison PLC | Jiangxi AICARE Medical Technology Co. Ltd. China | 01.08.20 |
USD 2200.00 | ||||||
83 | Infrared Thermometers | Invoice No. SU705-01/2020 dated 10th May 2020 | 1 | 3DH International Pvt Ltd | Huizhou Xiao’ ou Technology Co Ltd. China | 02.06.20 |
USD 26.00 | ||||||
84 | Infrared Thermometer | Invoice No. AJ2O2Oo412M dated 12th April 2020. | 576 | Access Engineering PLC | Bella (GZ) Inteligent Information Technology Co. Ltd | 12.06.20 |
USD 14465.00 | ||||||
85 | Infrared Thermometer | invoice No. 8881832387 dated 08th May 2020 | 40 | Advanced Digital Technology | Shangye Nuoan Medical Equipment Co Ltd. China | 26.06.20 |
USD 720.00 | ||||||
86 | Infrared Thermometer | Invoice No. 7310-2005-ATA-0000 dated 26th May 2020. USD 15.00 | 1 | ATA International Pvt Ltd | Joytech Healthcare Co Ltd, China | 10.06.20 |
87 | Infrared Thermometer | Invoice No. 20-0519 dated 29th May 2020 GBP 100.00 | 2 | ATA International Pvt Ltd | Norwood Instruments Ltd, England. | 10.06.20 |
88 | Infrared Thermometer | Invoice No. TW20200511-002 dated 11th May 2020. | 300 | Axero Associates Pvt Ltd | Chongqing Guiguzi Medical Device Technology Co., Ltd. China | 02.06.20 |
11100 | ||||||
89 | Infrared Thermometers only | Invoice No. HRP-007-Biomedica-2020 dated 04th May 2020 . USD 3000.00 | 100 | Biomedica (Pvt) Ltd | Quingdao Haier Biomedical Co Ltd, China | 19.06.20 |
90 | Infrared Thermometer | Invoice No. BPP20200428M2 dated 28th April 2020. | 123 | Burse Pharmaceuticals Pvt Ltd | Hunan Honggao | 09.06.20 |
USD 2583.00 | Electronic Technology Co., Ltd, China | |||||
91 | Infrared Thermometer | Invoice No. CHEC/BG/00054 dated 13th May 2020 USD 4200.00 | 140 | China Harbour Engineering Company Lanka Ltd | Shenzhen Quick Zoom Technology Co., Ltd. China | 11.06.20 |
92 | Infrared Thermometer | Invoice No. KTD2020051021EV dated 19th May 2020. USD 10000.00 | 505 | Chemsoul Health Care (Pvt) Ltd | Henan Bingzun Industrial Co., Ltd. China. | 02.06.20 |
93 | Infrared Thermometer | Invoice No. 20200519 dated 19th May 2020 | 100 | Exclusive designer fabrics Pvt Ltd | Hangzhou Hua’an Medical & Health Instruments Co., Ltd. China | 02.06.20 |
USD 2700.00 | ||||||
94 | Infrared Thermometer | Invoice No. PI-SCW08052 dated 29th May 2020 | 20000 | Dowell Medico Pvt Ltd | Harbin Xiande Technology Development Co. Ltd. China | 09.06.20 |
USD 600000.00 | ||||||
95 | Infrared Thermometer | Invoice No. LH20200426 dated 26th April 2020 | 80 | Eco Fresh World International Pvt Ltd | Huizhou Xiaoou Technology Co Ltd. China | 11.06.20 |
USD 2560.00 | ||||||
96 | Infrared Thermometers | Invoice No. BST20200422 dated 22ndApril 2020 | Future Need | Shenzhen Besiter Power Bank Technology Co., Ltd, China | 18.06.20 | |
97 | Infrared Thermometer | Invoice No. 3/13/2020 dated 03rd March 2020 | 25 | hSenid Business Solutions | Shenzhen kangzhan communication electronics Co., Ltd, China | 02.06.20 |
USD 1541.00 | ||||||
98 | Infrared Thermometers | Invoice No. SUP20200420 dated 20th April 2020 | 50 | Hummingbird International (PVT) Limited | Henan Bingzun lndustrial Co., Ltd. China | 16.06.20 |
USD 1450.00 | ||||||
99 | Infrared Thermometers | Invoice No. Z360B dated 20th May 2020 | 1000 | Imedra Healthcare (Pvt) Ltd | Ningbo Shangcun Electronic Co., Ltd., China | 17.06.20 |
USD 22000.00 | ||||||
100 | Infrared Thermometers | Invoice No. 1079071825 dated 03rd June 2020 | 60 | Jagath Kulunuguna | Guizhou Xinhui Optoelectronic Technology Co., Ltd. China | 19.06.20 |
USD 810.00 | ||||||
101 | Infrared Thermometers | Invoice No. 20WT0431 dated 20th May 2020 | 500 | Kamsons Trading Company (Pvt) Ltd | Shenzhen Changkun Technology Co Ltd. China | 25.06.20 |
USD 11950.00 | ||||||
102 | Infrared Thermometer | Invoice No. H12YB20011 dated 26th April 2020 | 100 | Lancor Rubber Industries | Shenzhen Ruiankang Technology Co., Ltd., China | 01.06.20 |
USD 3350.00 | ||||||
103 | Infrared Thermometer | Invoice No. PI20200401-LK06 dated 26th May 2020 | 200 | Lanka Tiles PLC | Guangdong Stable Medical Technology Co. Ltd. China | 02.06.20 |
USD 7200.00 | ||||||
104 | Infrared Thermometer | Invoice No. CELCN2020SRI dated 18th April 2020 | 1000 | Mel Wood International | Guangzhou Tida Electronic Technology Co Ltd. China. | 16.06.20 |
USD 10000.00 | ||||||
105 | Infrared Thermometers | Invoice No. EI20052101002TH dated 23th May 2020 | 2 | Metropoliton Office (Pvt) Ltd. | Zhangye Nuoan Medical Equipment Co., Ltd. China | 22.06.20 |
USD 44.00 | ||||||
106 | Face Recognition Thermometer | Invoice No. LE200326 dated 26th March 2020 | 1 | Metropoliton Office (Pvt) Ltd. | Shenzhen Shinyloam Electronics Co Ltd, China | 01.07.20 |
107 | Infrared Thermometer | Invoice No. CC2005060401 dated 25th May 2020 | 50 | Monali Traders | Xuchang Chicheng Electric Co., Ltd. China | 02.06.20 |
USD 1575.00 | ||||||
108 | Infrared Thermometer | Invoice No. GS20200603 dated 03rd May 2020 | 600 | Nobel Traders | Guizhou Xinhui Optoelectronic Technology Co Ltd. China | 11.06.20 |
USD 8871.00 | ||||||
109 | Infrared Thermometer | Invoice No. HJQ2020051908 dated 19th May 2020 | 1000 | Orient Global Logistics Pvt Ltd | Fuzhou Meirun Medical Device Technology Co Ltd. China | 02.06.20 |
USD 12000.00 | ||||||
110 | Infrared Thermometer | Invoice No. H12YB20011 dated 03th May 2020 | 26 | Miss Oshika Peiris | Quality Technology Industrial Co. Ltd., China. | 01.06.20 |
USD 604.50 | ||||||
111 | Infrared Thermometers | Invoice No. 2020/56 dated 24th May 2020 | 540 | Paper Corner | Hunan Wei Ding Information Technology Co. Ltd. China | 18.06.20 |
USD 4800.00 | Shenzhen Everbest Machinery Industry Co. Ltd. China | |||||
112 | Infrared Thermometer / | Invoice dated 04th May 2020 | 5000 | PCL Solutions (Pvt) Ltd | Shenzhen Bless Electronic Technology Co. Ltd, China. | 07.07.20 |
USD 9000.00 | ||||||
113 | Infrared Thermometer | Invoice No. LINK2020API dated 11th April 2020. | 100 | PhiloBiotics Private Limited | Alicn Medical (Shenzhen), Inc. China | 02.06.20 |
USD 4540.00 | ||||||
114 | Infrared Thermometer | Invoice No. JG20200528-014. | 12 | RCS2 Technologies (PVT) Limited | Shenzhen Qiangwei Electronic Co., Ltd. China | 09.06.20 |
USD 1057.00 | ||||||
115 | Infrared Thermometer/ Goggles/ Face Shield/ Gloves | Invoice No. 88537 dated 20th May 2020 | Rio Marketing (Pvt) Ltd | Shenzhen Qiangwei Electronic Co., Ltd. China | 15.06.20 | |
116 | Infrared Thermometers | Invoice No. BIOBASE2020 0512 LK dated 12th May 2020. | 100 | S & D Associates | Guangzhou Sunray Medical Apparatus Co., Ltd. China | 25.06.20 |
USD 4000.00 | ||||||
117 | Infrared Thermometer | Invoice No. 20WIN-T585JEP dated 26th May 2020 | 1002 | S J Enterprises Pvt Ltd | Hunan Honggao Electronic Technology Co. Ltd. China. | 03.06.20 |
USD 6900.00 | ||||||
118 | Infrared Thermometer | Invoice No. 019912 dated 20th May 2020. | 252 | S & S Trading | Chongqing Guiguzi Medical Technology Co. Ltd. China. | 02.06.20 |
USD 5800.00 | ||||||
119 | Infrared Thermometer | Invoice No. SS20200519 dated 19th May 2020. | 200 | S & S Trading | Harbin Xiande Technology Development Co., Ltd. China | 11.06.20 |
USD 3200.00 | ||||||
120 | Infrared Thermometer | Invoice dated 27th May 2020. | 4 | Samson Engineers Pvt Ltd | Shenzhen Medek Bio Medical Co Ltd. China. | 01.06.20 |
121 | Infrared Thermometers | Invoice No. FJ200522 dated 22nd May 2020. | 30 | Scientific Instruments (Pvt) Ltd | Shenzhen Zhengkang Technology Co Ltd. China | 25.06.20 |
USD 898.00 | ||||||
122 | Infrared Thermometer | Invoice No. MC20200527R dated 27th May 2020. | 100 | S.E.A.P.L. Automation Systems (Pvt) Ltd | Guangzhou Sunray Medical Apparatus Co., Ltd. China. | 26.06.20 |
USD 1715.00 | ||||||
123 | Infrared Thermometer | Invoice No. 202004008 dated 27th April 2020. | 100 | Senarathne Holdings Pvt Ltd | Shenzhen LeZhongxing Technology Co., Ltd. China. | 02.06.20 |
USD 985.00 | ||||||
124 | Infrared Thermometer | Invoice No. ARH200428C dated 28th April 2020. | 50 | Sitech Engineering Solutions Pvt. Ltd | Penrui Biotech Inc, China | 25.06.20 |
USD 1750.00 | ||||||
125 | Infrared Thermometers | Invoice No. 20SMR0426LK dated 28th April 2020. | 40 | Sky Elevator Tech (Pvt) Ltd | Zhengzhou AiQURA Intelligent Technology Co., Ltd., China. | 17.06.20 |
USD 1760.00 | ||||||
126 | Infrared Thermometers | Invoice No. SON20200429A | 360 | Skyray Associated | Guizhou Tekang Electronic Co., Ltd., China. | 01.07.20 |
USD 6400.00 | ||||||
127 | Infrared Thermometers | Invoice No. ES20200521577KL dated 25th May 2020. | 16541 | Softlogic Computers Pvt Ltd | Shenzhen Estar Technology Group Co. Ltd (HQ), China | 03.06.20 |
USD 281200.00 | ||||||
128 | Infrared Thermometer | Invoice No. XST-A-20200631-KE-001 dated 26th May 2020. | 2 | Softlogic Computers Pvt Ltd | Hunan Honggao Electronic Technology Co., Ltd. China. | 02.06.20 |
USD 36.00 | ||||||
129 | Infrared Thermometers | Invoice No. PS00514 dated 14th May 2020. | 160 | Star Garments (Pvt) Ltd. | Kunming Far Stars Diamond Craft Co. Ltd. China | 20.06.20 |
USD 4800.00 | ||||||
130 | Infrared Thermometers | Invoice No. 2020040001 dated 21st April 2020. | 240 | Healthguard Pharmacy Ltd | Shenzhen Bless Electronic Technology Co. Ltd, China. | 07.07.20 |
USD 14400.00 | ||||||
131 | Infrared Thermometer | Invoice No. ZZDF-20200509-03 dated 9th May 2020. | 1008 | TECHNIP Engineering Company | Zhejiang Mondial Electronic Technology Ltd. China. | 26.06.20 |
USD 24780.00 | ||||||
132 | Facial Scan Camera with Temperature | Invoice No. LKSJZ20200507 dated 07th May 2020. | 5 | Toppan forms Colombo Limited | ShenZhen Lean Kiosk Systems Co., Ltd, China. | 25.06.20 |
Control System | USD 4440.00 | |||||
133 | Infrared Thermometer | Invoice No. 20KNS0507 dated 07th May 2020. | 1020 | Transco Marketing Pvt Ltd | Zhongshan Jinli Electronic Weighing Co., Ltd. China. | 02.06.20 |
134 | Infrared Thermometer | AW Bill No. 5194576435 dated 26th May 2020. | 50 | Wayamba Technical College of Halpara Junction | Harbin Xiande Technology Development Co., Ltd, China. | 26.06.20 |
USD 1300.00 |
PCR test kits |
||||||
Applicant |
Product |
Manufacturer/ Supplier |
Date Received |
WOR issued date |
Quantity |
Invoice Number |
Ministry of Health |
Covid 19 Nucleic acid diagnostic kit for RT PCR test |
China Sinopharm International Corporation - China |
28.03.2020 |
28.03.2020 |
42 boxes |
SPINTL20-TY007LK-1) |
Asiri Surgical Hospital |
Z- path 2019 n cov std Genesig Standard Kit Real Time PCR detection kit for 2019-nCoV |
Primer Design Limited, UK |
18.03.2020 |
18.03.2020 |
03 kits |
0000601657 |
Nawaloka Hospital |
New Corona Virus-2019 nCo nucleic acid detection kit |
Shanghai GeneoDx Biotech Ltd, China |
10.03.2020 |
18.03.2020 |
20 boxes (50 tests/box) |
20200316 |
Microtech Biological (Pvt) Ltd, |
VIASURE SARS -CoV-2 Real Time PCR Detection kits |
Certest Biotec SL - Spain |
19.03.2020 |
26.03.2020 |
2 kits |
2030021 |
12.05.2020 |
20.05.2020 |
10 kit |
E20/2020397 |
|||
22.06.2020 |
25.06.2020 |
75 + 26 |
PROF- 20/2000584 PROF- 20/2000585 |
|||
Avon Pharmo Chem (Pvt) Ltd, |
Altona RealStar SARS – CoV -2 RT PCR Kit 1.0 |
Altona Diagnostics GmbH-Germany |
18.03.2020 |
26.03.2020 |
40 kits |
A20-01656 |
08.04.2020 |
26.04.2020 |
15 +25 kits |
R+ 20002356 & A20-02322 |
|||
27.04.2020 |
30.04.2020 |
50 kits |
A20-02630 |
|||
12.05.2020 |
28.05.2020 |
200 kits |
A20-02997 |
|||
George Stuarts Health (Pvt) Ltd |
IVD Real Time Detection Test Kit (PCR) (Standard M nCov Real Time Detection Kit |
SD Biosensor, Inc. Korea |
19.03.2020 |
25.03.2020 |
10 kits |
KMI200317-2 |
Sunshine Healthcare (Pvt) Ltd |
PCR Kit for detecting of SARS-COV-2 of RdRp. Gene and Sarbecovirus of E gene (LabGun COVID -19 Assay) |
Labgenomics Co. Ltd, Korea for Siemens Healthcare , India |
02.04.2020 |
17.04.2020 |
10 kits |
EQL-3006731441 |
Biomedite (Pvt) Ltd |
1 copy COVID-19 qPCR Multi Kit |
1 Drop Inc, Korea |
10.04.2020 |
29.04.2020 |
10 kit |
Invoice : PI-200327 |
GeneFinder Covid-19 Plus RealAmp |
Osang Healthcare Co. Ltd, Korea |
10.04.2020 |
21.05.2020 |
10 kits |
INF_200329-02 |
|
20 kits |
INF_200609-02 |
|||||
Dowell Medico (Pvt) Ltd |
Quanti virus SARS Cov-2 test |
Diacarta Inc, USA |
25.04.2020 |
26.04.2020 |
100,000 |
(Invoice :SL-DM-MPFI-20/01) |
Intergen Ltd |
Genesig® COVID-19 assay (2019- nCoV) |
Primer design , UK |
31.03.2020 |
11.05.2020 |
04 kits |
0000700993 |
HTIS Lanka Pvt Ltd |
Accupower Covid 19 Real Amp Kit |
Bioneer Corporation -Korea |
28.04.2020 |
01.05.2020 |
01 box |
IME-CI-200424-02 |
28.05.2020 |
01.05.2020 |
20 kits |
IME- CI- 200520-01 |
|||
Procare Holdings (Pvt) Ltd |
Allplex 2019-nCov assay |
Seegene Inc, Korea |
27.04.2020 |
04.05.2020 |
7 kits |
C-200422023 |
20.05.2020 |
28.05.2020 |
30 kits |
20200518 |
|||
05.06.2020 |
16.06.2020 |
125kits+ 125 kits |
2020060201 and 2020060202 |
|||
BELA International (Pvt) Ltd |
Powercheck 2019-nCov Real Time PCR Test Kit |
Kogene Biotech Co. Ltd, Korea |
04.05.2020 |
06.05.2020 |
1 kit |
KB20200429_2 |
Ministry of Health |
Novel Coronavirus(2019-nCov) Nucleic Acid Diagnostic Kit(PCR- Fluorescence probing) |
China Sinopharm International Corporation , China |
09.05.2020 |
09.05.2020 |
30000 tests |
SPINTL 20- TY 027AS-LK-1 |
Ministry of Health |
Covid -19 Rapid test kits |
Through MSD |
08.05.2020 |
1000kits |
No: 278 (File No: CHI/Mis/2020) |
|
Elshaddai Enterprises |
New Coronavirus Covid -19 Nucleic acid detection kit (Fluorescent RT –PCR method) |
HunanRumMeiGene TechnologyCo.Ltd,China |
29.04.2020 |
11.05.2020 |
1350 tests |
RM-2020-4-15-05 |
Apcot Marketing (Pvt) Ltd, |
iAMP Covid-19 detection kit |
Atila Biosystem Inc, USA for Fujirebio Europe N.V., Belgium |
09.05.2020 |
23.05.2020 |
500 (100 T) |
5010038400 |
HTIS Lanka Private Limited |
Accupower Covid- 19 Real time PCR kit |
Corporation, Korea |
01.06.2020 |
20 kits |
IME- CI- 200520-01 |
|
United Nations Development Programme office in Sri Lanka |
Novel Coronavirus (2019-nCov) nucleic acid diagnostic kit and QIAamp viral RNA mini kit |
Sansure Biotech Inc, China and Qiagen , Germany |
08.06.2020 |
18.06.2020 |
417 kits |
202000679 |
Prime Minsiters Office , Sri Lanka |
PCR test kits for Covid-19 |
Micro Biomed , Korea |
22.05.2020 |
30.06.2020 |
6 kits |
MBM20P01-530 |
Canoe Medicare (Pvt) Ltd |
Dignovital Covid - 19 Detection Kit (SARS- Cov – 2 Realtime PCR kit 100 Test CE- IVD) |
RTA Laboratories Biological Products Pharmaceutical and machinery Industry. |
24/08/2020 |
|||
Procare Holdings Pvt Ltd |
RT PCR Kits |
Seegene Inc. Korea |
26/10/2020 |
|||
Ceyoka Pvt Ltd |
Accupower SARS – CoV – 2 Multiplex Real – Time RT- PCR Kit |
Bioneer Corporation - Korea |
27/10/2020 |
|||
George Stuart Health Pvt Ltd |
Real Time PCR for IVD test with qualitative analysis COVID – 19 Test Kit Accessories |
SD Biosensor Inc. Korea |
26/10/2020 |
|||
Medical Supplies Division |
Real-Time RT-PCR Kit and Liquid Handling Worksatation |
BGI Health HK Company Limited |
13/11/2020 |
|||
Pro Care Holdings Pvt Ltd |
RT PCR Kits |
Seegene Inc. Korea |
06/10/2020 |
|||
Shield Medical Pvt Ltd |
Covid – 19 Real Time PCR K it |
Hong Kong Hybribio Ltd – Hong Kong |
31.12.2020 |
|||
Shield Medical Pvt Ltd |
Covid – 19 Real Time PCR Kit |
Hong Kong Hybribio Limited – Hong Kong |
19/05/2021 |
|||
Microtech Biological Pvt Ltd |
VIASURE SARS – COV – 2 & UK Variant Real Time PCR Detection Kit |
Certest Biotec SL - Spain |
17/05/2021 |
Name of Importer |
Name of Manufacturer |
Brand/Model |
Digital Cells (Pvt) ltd |
Shenzhen IMDK Medical Technology Co, Ltd – China |
iMDK C101A2 – OLED Qty – 15,000 |
Digital Cells (Pvt) ltd |
Shenzhen IMDK Medical Technology Co, Ltd – China |
iMDK C101A2 Qty – 105,000
|
Mega Meditech (Pvt) ltd |
Zhuhai Linte Medical Instrument Co, Ltd – China |
Lintemed LT F20 Qty – 1000 |
George Steuart Health
|
Shenzhen Lepu Intellight Medical Equipment Co. ltd – China
|
Lepu LOX100A Qty - 1000 |
George Steuart Health
|
Shenzhen Lepu Intellight Medical Equipment Co. ltd – China
|
LOX100C Qty- 1000
|
George Steuart Health
|
Shenzhen Lepu Intellight Medical Equipment Co. ltd – China
|
LOX100A Qty- 1000
|
Total Qty |
124,000 |
Waiver of Registration Approved List – Device (September 2021 to December 2021) |
|||||||||
|
|||||||||
|
Date of Submission |
NMRA Ref: Number |
Item |
Qty |
Applicant |
Manufacturer/Supplier |
Reason for WOR |
Remarks |
WOR Committee Approval |
1 |
25/08/2021 |
|
Freund's Adjuvant |
5 |
University Of Jaffana |
Sigma Aldrich - Germany |
For Research Purpose |
New model. |
Recommended only for this consignment. |
2 |
25/08/2021 |
|
Sperm Analyzer with Standard Accessories, Spare parts and reagents |
1 |
Anlytical Instruments Pvt Ltd |
M.E.S Ltd - Israel |
|
|
Recommended only for this consignment |
3 |
25/08/2021 |
|
Pulse Oximeter (TD - 8255) |
500 |
Mega Meditech (Pvt) ltd |
TaiDoc Technology Corporation - Taiwan |
Due to the current Covid - 19 pandemic in the country and shortage in the market |
Manufacture already registered with local agent certificate issued by Health Authority - Taiwan, EC Certificate, ISO Certificate are available. |
Recommended and issue WOR for 02 Samples. |
4 |
25/08/2022 |
|
Ultrasound Imaging System |
1 |
Biomed International Pvt Ltd |
GE Vingmed Ultrasound AS - Norway |
|
Item already registered and has valied registration (D/2358). WOR requesting to import spare parts which are manufactured at different site. |
Recommended only for this consignment |
5 |
25/08/2023 |
|
Lab Reagents |
1 |
Medical Research Institiute |
VWR International GMBH - Austaria |
Humanitarian donation by WHO |
|
Recommended only for this consignment |
6 |
27/08/2021 |
|
Antigen Rapid Test Kit |
75 |
Mahamewna Maha Viharaya |
Pradeep Chamil Wanniarachchige - UK |
Personal Use of the monk Mahamewnawa Monastery |
|
Recommended only for this consignment |
7 |
30/08/2021 |
|
PPE Kits |
300 |
Rotary Club of Kandy |
Rotary Australia World - Castle Hill, NSW 2154 |
Donation |
Donation from Rotary Australia |
Recommended only for this consignment |
8 |
31/08/2024 |
|
Covid 19 Anti Rapid Test (ART) Self - Test Kits (Brand : PANBIO) |
03 (Pulse Oximeter) 10 ( |
Tea Tang (Pvt) ltd |
Abotte Rapid Diagnostics Jena GMBH - Germany |
Fro Release the items from Sri Lanka Customs. |
|
Panbio Antigen Rapid Kits are registered. Recommended 03 Pulse Oximeter use for only personal. |
9 |
1/9/2021 |
|
Vantilatior Machine |
1 |
Medical Supplies Division |
Jocelyne Rojas - United States |
Donation |
Donation but in the invoice it is mention has Commercial Purpose |
Recommended only for this consignment and advice to submit to be validated by an end user. |
10 |
1/9/2021 |
|
Covid 19 Test Kits (Model : FANABOI) |
25 Test Kits |
Hyosung Heavy Industries Corporation |
|
|
For internal use by the corean Company |
Recommended WOR allowed only for personal use. |
11 |
1/9/2021 |
|
HLA Reagents |
|
Emar Pharma Pvt Ltd |
One Lambda – USA |
|
Machine Specially 3 agent and manufacture registered with NMRA. In Aril 2021 also WOR Issue. |
Recommended only for this consignment and need to be registered for future supply and expedite registration. |
12 |
9/9/2021 |
MD/03/09/2021 |
CAP EQA test Kits |
|
Bio Medica (Pvt) ltd |
College of American Pathologists - America |
|
For external quality assurance Programme of the Lab. |
Recommended only for this consignment and advice to submit Invoice. |
13 |
9/9/2021 |
MD/04/09/2021 |
Duodeno Videoscope (Model-TJF-150) |
1 |
Mediquipment Limited |
Olympus Medical System Co. - Japan |
For Provincial General Hospital - Badulla |
Repaired item |
Recommended only for this consignment. |
14 |
9/9/2021 |
MD/06/09/2021 |
Laboratory Specimens |
N/A |
Lanka Hospital Diagnostics (pvt) ltd |
College of American Pathologists - America |
External Quality Assuraance |
|
Recommended only for this consignment. |
15 |
13/09/2021 |
MD/16/09/2021 |
Antigen Rapid Test Kits |
5000 |
Junaht International Pvt Ltd |
Biolidics Limited - Singapore |
|
New Manufacturer |
Not recommended and advice to register the product. |
16 |
16/09/2021 |
MD/25/09/2021 |
Blood Glucose Test Strip |
2 |
Nagananda International Institute for Buddhist Studies
|
M/S Lin - Thaiwan |
Personal Use |
|
Recommended only for this consignment. |
17 |
16/09/2021 |
MD/26/09/2021 |
10 Tubes (5 dried plasma Samples and 5 buffer) |
10 |
National STD/AIDS Control Programme |
|
For NSACP |
|
Recommended only for this consignment. |
18 |
17/09/2021 |
|
Pulse Oximeter |
|
CT Trading Company |
Shenzhen IMDK Medical Technology Co.ltd - China |
|
|
Recommended. |
19 |
17/09/2021 |
|
Auto-Disable Syringes 0.5ml |
|
SPC |
Hi—Tech Medical Private ltd - India |
|
|
Recommended Only for this consignment. |
20 |
24/09/2021 |
MD/41/09/2021 |
Humidifier |
1 |
Dinesh Dharmadasa |
CUI ZOU - China |
For Custom Clearance |
Not commercial value. |
Recommended. As per the recommendation of the secretory, State ministry allowed only for this consignment. |
21 |
24/09/2021 |
MD/49/09/2021 |
Root Canal Cement |
10 |
Dilshan De Silva |
Septodont - France |
For Custom Clearance |
New Manufacturer. |
Recommended only for this consignment.
|
22 |
24/09/2021 |
MD/50/09/2021 |
Vedio Bronchoscopes and Colonoscope |
3 |
Mediquipment Limited |
M/S Olympus Medical System Co. - Japan |
For Teaching Hospital Peradeniya and Lady Ridgway Hospital |
Re import of Repaired item. |
Recommended only for this consignment. |
23 |
28/09/2021 |
MD/136/09/2021 |
Oxygen Flowmeter |
10 |
Medilon Equipment (pvt) ltd |
Jinhua Starcare Medical Supplies Co.ltd - China |
Donation to Government Institute. |
New manufacturer |
Recommended only for this consignment. |
Non-Breathing Oxygen Mask |
1,000 |
Jinhua Starcare Medical Supplies Co.ltd - China |
|||||||
|
|
|
Air Flometer |
80 |
|
Jinhua Starcare Medical Supplies Co.ltd - China |
|
|
|
Flow Control Value Oxygen Concentrator |
5 |
Jinhua Starcare Medical Supplies Co.ltd - China |
|||||||
Oxygen Flowmeter with Humidirier |
50 |
Jinhua Starcare Medical Supplies Co.ltd - China |
|||||||
24 |
28/09/2021 |
MD/137/09/2021 |
Anticoagulant Solution 500ml |
|
Emar Pharma (pvt) ltd |
Heamonetics S.A. - Switzerland |
SPC Tender |
New Manufacturing Site of an already registered product with NMRA. |
Recommended only for this consignment and advised to submit the dossier. |
25 |
28/09/2021 |
MD/138/09/2021 |
Consumables for Stem Cell Harvesting Kits |
|
Apcot Marketing (pvt) ltd |
Maco Pharma Rue Lorthiois 59420, Mouvaux - France |
For National Blood Tranfusion Service (NBTS) |
manufacturer already registered with this local agent. At present no registered supplier. |
Recommended only for this consignment. |
26 |
24/09/2021 |
MD/64/09/2021 |
Oxygen Generator |
1 |
Pelemix Lanka (pvt) ltd, 115/1/1, Jawatta Road, Colombo 05 |
N/A |
|
Donation from Head Office to Sri Lankan Branch. |
Recommended only for this consignment. |
27 |
30/09/2021 |
MD/150/09/2021 |
Spinal Board / Dental Chair / Digital BP Aperator / Televesion / Spot Lamp / Stethoscope / ECG Machine / Delivery set Suture set / Nebulizer Machine / Sucker Machine |
18 |
Management and Advisory Committee of Proposed World Heritage Site of Seruwila Raja Maha Viharaya for UNESCO |
Sri Lanka National Commission for UNESCO |
For Seruwila Rural Hospital |
Donation DH Seruwila |
Recommended only for this consignment. |
28 |
30/09/2021 |
MD/153/09/2021 |
FACS Presto Cartridge Kits |
11 |
National STD/AIDS Control Programme |
BD International - Belium |
Donation to STD |
|
Recommended only for this consignment. |
29 |
30/09/2021 |
MD/163/09/2021 |
GXHIV-1-CE-10 Kit, 10 Test, HIV QUANT CE IVD |
28 |
National STD/AIDS Control Programme |
Cepheid - France |
Donation |
|
Recommended only for this consignment. |
30 |
30/09/2021 |
MD/175/09/2021 |
Lab Regents (Cell Culture, L-Glutamine) / Cell_Culture / L_Glutamine |
3 |
Medical Research Institute |
VWR International GnbH - Malaysia |
Donation |
Donation to MRI |
Recommended only for this consignment. |
31 |
30/09/2021 |
MD/178/09/2021 |
Fingertip Pulse Oximeter (A2) / N95 Mask |
Oximetr - 40 / N95 Mask 60 |
Amila Welendagoda |
Shenzhen IMDK Medical Technology Co.ltd - China |
Donation |
New Manufacturer |
Recommended only for this consignment. |
32 |
30/09/2021 |
MD/181/09/2021 |
Face Shield / Face Mask Disposable / Sport Mask . Kids Masks |
382 |
Medical Supplier Devision |
SymplyHelp - USA |
Donation |
|
Recommended only for this consignment. |
33 |
24/09/2021 |
MD/38/09/2021 |
Dental Accessories / Composites |
|
PCL Solutions (Pvt) ltd |
DMP Dental Industry S.A - Greece |
Already recommended in the Committee Held on 23/08/2021 |
|
Recommended only for this consignment. |
34 |
30/09/2021 |
MD/152/09/2021 |
Super Snap x-trme technique mini kit for finishing and polishing composite restoration |
6,500 |
Ogaki & Company |
Shoufu Inc - Japan |
Submitted to WOR Committee held on 23/08/2021 and to WOR committee held on 17/09/2021 and committee decision was SPC Tender documents not available and register the product. |
|
Recommended only for this consignment. |
35 |
30/09/2021 |
MD/113/09/2021 |
Q.E.D.A.150 Saliva Alchol Test |
1300 |
George Steuart Health (Pvt) ltd |
Orasure Technologies Inc - USA |
Submitted to WOR Committee held on 23/08/2021 and Not Recommended and again appeal submitted committee held on 17/09/2021 and Advised to submit recommendation from college of Forensic Pathologists of Sri Lanka. (Document Submitted)
|
|
Recommended only for this consignment and. |
36 |
30/09/2021 |
MD/170/09/2021 |
Paste Carriers |
5700 |
SS Dento Pharma |
Mani Inc - Japan |
Submitted to WOR Committee held on 03/09/2021.
|
|
Recommended only for this consignment. Indent Number: LP/DHS/S/WW/138/660AM/19 |
37 |
30/09/2021 |
MD/151/09/2021 |
Integrated Dental Unit |
03 |
Dent Re |
Guangdong Yodeng Medical Apparatus Co.ltd - China |
|
For Dental |
Recommended only for this consignment. |
38 |
6/10/2021 |
MD/206/10/2021 |
Portable Eternal Feeding Pump with accessories / Eternal Feeding Pump Giving set. |
15 + 60 |
A. Baur & Co. (pvt) ltd |
Azium Mtech SA - Switerland |
For Three Government Hospitals |
Already registered Product. (D697NP / D1118NP) Manufacturing Site Change. |
Recommended Only for This Consignment. And for future supply product need to be registered with NMRA. |
39 |
6/10/2021 |
MD/213/10/2021 |
Reagents for Hematology Analyzer (MEK-680) |
30 |
Hemas Surgicals & Diagnostics (Pvt) ltd |
Nihon Kohden - Japan |
For Hospital |
Already restered product full registration expierd reasonly and A/T to Hemas. (File No DVR 9928) |
Recommended only for this consignment and submit file for renewal of registration. |
40 |
4/10/2021 |
MD/246/10/2021 |
Reagents Calibrators & Controls for Hematology Analyzer |
40 |
Hemas Surgicals & Diagnostics (Pvt) ltd |
Nihon Kohden - Japan |
For Government Office |
Re agent wich are mention in the invoice not taly with registration certificates. (Model is different). A/T product from tmi Solution to Hemas. |
Can be Recommended if a copy of registration document for the specific model is provide. |
41 |
14/10/2021 |
MD/262/10/2021 |
Laser Medical Thermometer |
202 |
U.G.K. Nilmini |
Bella (Guangzhou) Intelligent Information Technology Co.ltd - China |
Donation for the Godakawela Pradeshiya Sabha |
|
Recommended only for this consignment. |
42 |
14/10/2021 |
MD/263/10/2021 |
PCR Test Kit |
6 |
S. Thiruvarudkumar |
Minako Taskilan Glattsting - Switzerland |
Personal Use |
|
Recommended only for this consignment. Self-Testing PCR Kit send by a relative in overseas for personal of family. |
43 |
12/10/2021 |
MD/264/10/2021 |
Easy Beat Egg |
110 |
IY Marketing Services |
UPS Singapore PTE Ltd - Singapore |
|
|
Recommended only for this consignment. |
44 |
14/10/2021 |
MD/269/10/2021 |
Electro Medical Equipment (Mindary) |
20 |
Biomedica (Pvt) ltd |
Shenzhen Mindray Bio- Medical Electronic Co.ltd - China |
|
Re export to nepol |
Recommended only for this consignment. Approval for export. |
45 |
22/10/2021 |
MD/270/10/2021 |
Artificial Limbs |
1,075 |
Meththa Rehabilitation Foundation Guarantee.ltd |
The Meththa Foundation - UK |
For Clinic |
Donation for Row Material fabricating of artificial limbs. |
Recommended only for this consignment. |
46 |
22/10/2021 |
MD/271/10/2021 |
Machinery, Tools and Other Components |
|
Colombo Friend - in - Need Society |
Proactive Technical Orthopaedics (pvt) ltd - India |
|
Donation for fabricating artificial limbs. |
Recommended only for this consignment. |
47 |
22/10/2021 |
MD/272/10/2021 |
LED PT Phototherapy System |
1 |
Biomed International (pvt) ltd |
Datex - Ohmeda Inc - USA |
For Ruhunu Hospital Diagnostics |
Spare parts are imported in Vietnam (one unit) for already registered Phototherapy System. (File DVR/12483) |
Recommended only for this consignment. |
48 |
22/10/2021 |
MD/273/10/2021 |
Regents, Solutions Used in NGS Machines |
|
Credence Genomics (Pvt) Ltd |
Thermofischer Scientific - USA |
For Ion Torrent PGM and Gene Studio S5 Prime. |
Limited quantity for research purpose. |
Recommended only for this consignment. (For Research Purpose) |
49 |
22/10/2021 |
MD/275/10/2021 |
Mini Autoclave (Spare Parts) |
77 |
Mediquipment Limited |
Eschamann Technologies Ltd - UK |
Repaired Item |
Registration expired in 2017, not apply for renewal. (DVR/9328) |
Recommended only for this consignment. |
50 |
22/10/2021 |
MD/278/10/2021 |
Artificial Hands |
18 |
Colombo Friend - in - Need Society |
|
|
|
Recommended only for this consignment. (OTC) |
51 |
22/10/2021 |
MD/279/10/2021 |
Oxygen Concentrator |
60 |
Access International (Pvt) ltd |
Shenyang Canta medical Technology Co.ltd - China |
|
|
Recommended only for Part of this consignment. Only for 10L/min Oxygen Concentrator. (Qty-20 Pcs) Model: V5-WN-NS Brand - Canta. |
52 |
22/10/2021 |
MD/280/10/2021 |
Oxygen Concentrator |
3 |
Ruby Plastic (Pvt) ltd |
Shenzhen Deda Health Co.ltd - China |
For Personal Use |
|
Recommended only for this consignment. |
53 |
28/07/2021 |
- |
Bull Nose Oxygen Regulator |
320 |
Access International Pvt Ltd |
Dangyang Airtech Co.Ltd - China |
For Covid Centers |
07/08/2021 Committee Decision: Issue WOR only for 02 Samples. Need to submit samples for evaluation |
Sample evaluated and recommended only for this consignment and for future supply product need to be registered with NMRA. |
54 |
10/09/2021 |
MD/21/09/ 2021 |
Medical Oxygen Regulator |
500 |
Ovin Gases (pvt) ltd |
Ningbo MFLAB Medical Instruments Co.ltd - China |
For Hospitals |
|
Sample evaluated and recommended only for this consignment and for future supply product need to be registered with NMRA. |
55 |
02/07/2021 |
- |
Oxygen Regulator |
1000 |
Nevena Importers |
Danyang Airtech Co Ltd - China |
- |
07/08/2021 Committee Decision: Issue WOR only for 02 Samples. Need to submit samples for evaluation |
Sample evaluated and recommended only for this consignment. |
56 |
8/9/2021 |
|
Oxygen Concentrator (10L) |
200 |
Access International (Pvt) ltd |
Shenyang Canta Medical Tech. Co.ltd - China |
For Covid Centers |
|
Sample evaluated and recommended only for this consignment. (10L/min Oxygen Concentrator only) Model: V5-WN-NS Brand - Canta. |
57 |
15/09/2021 |
MD/66/09/2021 |
Oxygen Concentrator |
150 |
Delmege Forsyth & Co.ltd |
Jiangsu Folee Medical Equipment Co.ltd |
For Covid Patient |
|
Sample evaluated and recommended only for this consignment. For future supply product need to be registered with NMRA.
|
58 |
17/09/2021 |
MD/98/09/2021 |
Fingertip Pulse Oximeter |
1000 |
Pasific Trading Company |
Yibin Junxin Electronics Technology - China |
|
|
Sample evaluated and recommended only for this consignment. for future supply product need to be registered with NMRA. |
59 |
06/09/2021 |
|
Fingertip Pulse Oximeter |
2000 |
George Steuart Health (Pvt) ltd |
Shanghai Berry Electronic Tech Co.ltd - China |
Commercial Purpose |
|
Sample evaluated and recommended only for this consignment. for future supply product need to be registered with NMRA. |
60 |
06/09/2021 |
|
Fingertip Pulse Oximeter |
3750 |
Sunway Healthcare (pvt) ltd |
M/s Vizin India (Pvt) ltd - India |
Commercial Purpose |
|
Sample evaluated and recommended only for this consignment. For future supply product need to be restarted. |
61 |
30/09/2021 |
MD/145/09/2021 |
N95 Surgical Respirator (Niosh Standerd) |
1,875 |
Sisili Projects Consortium (pvt) ltd |
Rizhao Sanqi Medical & Health Articles Co.ltd - China |
|
Submitted to WOR Committee held on 01/10/2021 and Committee Decision was the policy of government of Sri Lanka, need clarification from secretory, State ministry for consider grating waiver. |
Recommended only for this consignment. For future supply product need to be registered with NMRA. |
62 |
30/09/2021 |
MD/146/09/2021 |
N95 Surgical Respirator (Niosh Standerd) |
75,000 |
Sisili Projects Consortium (pvt) ltd |
Rizhao Sanqi Medical & Health Articles Co.ltd - China |
|
Submitted to WOR Committee held on 01/10/2021 and Committee Decision was the policy of government of Sri Lanka, need clarification from secretory, State ministry for consider grating waiver. |
Recommended only for this consignment. For future supply product need to be registered with NMRA. |
63 |
30/09/2021 |
MD/147/09/2021 |
N95 Surgical Respirator (Niosh Standerd) |
100,000 |
Sisili Projects Consortium (pvt) ltd |
Rizhao Sanqi Medical & Health Articles Co.ltd - China |
|
Submitted to WOR Committee held on 01/10/2021 and Committee Decision was the policy of government of Sri Lanka, need clarification from secretory, State ministry for consider grating waiver. |
Recommended only for this consignment. For future supply product need to be registered with NMRA. |
64 |
24/09/2021 |
MD/52/09/2021 |
1. Spare Parts and Accessories for Defibrillators. 2. Spare Parts and Accessories for Patient Monitors (Model: life scope / Dismo) |
|
Hemas Surgical & Diagnostics (Pvt) ltd |
Nihon Kohden - Japan |
For Hospital |
Submitted to WOR Committee held on 01/10/2021 and Committee Decision was Need Legal Advice. |
According to given legal advice, recommended only for this consignment. For future supply product need to be registered with NMRA. |
65 |
30/09/2021 |
MD/134/09/2021 |
3M N95-1860 Fce Mask |
100,000 |
Cloud Healthcare (pvt) ltd |
3M Vietnam Limited - Vietnam |
SPC Tender |
Submitted to WOR Committee held on 01/10/2021 and Committee Decision was the policy of government of Sri Lanka, need clarification from secretory, State ministry for consider grating waiver. |
Recommended only for this consignment. For future supply product need to be registered with NMRA. |
66 |
26/10/2021 |
25/10/2021/002 |
Injection Syringe Pumps (Model:SP95) |
5 |
Mr. M.I. Wijegooneratne |
|
Donation to Ragama Hospital |
|
Recommended only for this consignment. |
67 |
27/10/2021 |
18/10/2021/003 |
Reagents Calibrators & Controls for Hematology Analyzer |
600 |
Hemas Surgical & Diagnostics (Pvt) ltd |
Nihon Kohden - Japan |
For Office of Provincial Director of Health Services |
|
Recommended only for this consignment. |
68 |
27/10/2021 |
18/10/2021/004 |
Spare Parts for Patient Monitor |
15 |
Hemas Surgical & Diagnostics (Pvt) ltd |
Nihon Kohden - Japan |
For DGH - Polonnaruwa |
|
Recommended only for this consignment. |
69 |
27/10/2021 |
18/10/2021/014 |
Spare Parts and Accessories for defibrillator |
12 |
Hemas Surgical & Diagnostics (Pvt) ltd |
Nihon Kohden - Japan |
|
|
Recommended only for this consignment. |
70 |
2/11/2021 |
MD/314/11/2021 |
AC-CCR Flow Cast Basophil Activation Test Flow Cytometry and Allergens |
One Each |
HighChem R Ceylon Company (Pvt) ltd |
Buhlmann Laboratories - Switzerland |
For Allergy, Immunology and Cell Biology Unit, University of Sri Jayewardenepura. |
For research Purpose. New Manufacturer. |
Recommended only for this consignment. |
71 |
5/11/2021 |
MD/323/11/2021 |
KN95 / FFP2 Face Mask |
200,000 |
Race Course Athletic Club |
Shenzhen Allround Tech Limited |
Donation Sports Club |
New Manufacturer |
Recommended only for this consignment. Need to Submit distribution List. |
72 |
5/11/2021 |
MD/324/11/2021 |
Sturdy Container 2lt |
42 |
National Programme for Tuberculosis Control & Chest Diseases. |
GFATM |
Donation to NPTCCD |
|
Recommended only for this consignment. |
73 |
9/11/2021 |
MD/331/11/2021 |
Oxygen Concentrator - Canta (10 L) |
3 |
gsk - SmithKline Beecham (Pvt) ltd |
Shenyang Canta Medical Tech. Co.ltd - China |
For Factory Staff |
New Manufacturer |
Recommended only for this consignment. The same brand previous evaluated and approved. This is only for staff use only 3 unit and not for commercial purpose. |
74 |
9/11/2021 |
MD/337/11/2021 |
Tattoo Cartridge Needles |
100 |
R.J. Saman Kumara |
Suzhou Huali Tattoo Needles - China |
|
Listed Item |
Recommended only for this Consignment. |
75 |
9/11/2021 |
MD/338/11/2021 |
Spare Parts for Sterilizer System |
18 |
Mediquipment Limited |
Getinge Sterilization AB - Sweden |
Repaired Items |
Spare Parts for discontinue registered item. (DVR/11509) |
Recommended only for this Consignment. |
76 |
11/11/2021 |
MD/340/11/2021 |
Medical Equipments |
74 |
Medical Supplies Division |
United Nation Children Funds |
Donation to MSD |
|
Recommended only for this consignment. |
77 |
11/11/2021 |
MD/341/11/2021 |
Gloves/Isolation gown/Masks (3ply) / Masks (KN95) |
918 |
Medical Supplies Division. |
Buddhist Union - Los Angeles |
Donation to MSD |
|
Recommended only for this consignment. |
78 |
09/09/2021 |
|
Fingertip Pulse Oximeter (PC-60B1) |
10,000 |
Instrumedic International (Pvt) ltd |
Lepu Medical Technology (Beijing) Co.ltd-China |
Commercial Purpose |
|
Sample evaluated and recommended only for this consignment. |
79 |
25/06/2021 |
|
Fingertip Oximeter (OLED Type) |
|
George Steuart Health |
Ath Inc - China |
|
|
Sample evaluated and recommended only for this consignment. |
80 |
11/11/2021 |
MD/342/11/2022 |
Medical Oxygen Concentrator / Medical Oxygen PSA (Model: OA 250-SK) |
1 |
Adelaide Sri Lanka Buddhist Vihara Inc |
Oxair Gas Systems - Australia / Oxair Gas Systems - India |
Donation to Adelaide Sri Lanka Buddhist Vihara Inc |
- |
Recommended only for this consignment. |
81 |
2/11/2021 |
MD/349/11/2021 |
Syringe Infusion Pump/Syringe pump with standard accessories (Perfusor Compact Plus) |
200 |
B Braun Lanka (Pvt) ltd |
B. Braun Melsungen AG - Germany |
Export to repaired items |
Export to repair Items. |
Recommended only for this consignment. |
82 |
10/11/2021 |
MD/350/11/2021 |
Lateral flow kit for family member with cancer |
1 |
N.Raveendran |
UK - Mainland |
For personal Use |
- |
Recommended only for this consignment. (For personal use of cancer patient) |
83 |
10/11/2021 |
MD/353/11/2021 |
Empty Hard Capsules Packing Pack (100%) Plastic / Hard Filling Machine Set |
3 |
Co-Operative Hospital Society ltd - Moolai |
|
|
- |
Recommended only for this consignment. Issue product categorization. |
84 |
19/11/2021 |
MD/357/11/2021 |
nTSH ELISA 20 Plate Kit |
80 |
Medical Supplies Division |
MP Biomedicals Asia Pacific Pte Ltd - United States of America |
For MSD |
Manufacturer Registered with NMRA. |
Recommended only for this consignment. |
85 |
19/11/2021 |
MD/358/11/2021 |
DELFIA nTSH (960T) Kit |
120 |
Medical Supplies Division |
PerkinElmer Singapore PTE Ltd - Finland |
For MSD |
Manufacturer Not Registered with NMRA. |
Recommended only for this consignment. |
86 |
1/12/2021 |
MD/379/12/2021 |
Oxygen Concentrator (Model:(OZ)-02-5-01GWO) |
15 |
Tmi Solutions (Pvt) ltd |
Guangdong Owgels Science and Technology Co.ltd- China |
Sri Lanka Army Headquarters Purchase Order |
|
Recommended. WOR allowed import only one unit for testing at BMES. |
87 |
1/12/2021 |
MD/422/12/2021 |
Syringe Filter Unit, Sterile 33mm |
200 |
Atlas Populi (Pvt) ltd |
Merck KGaA, Darmstadt - Germany |
|
Manufacturer Not Registered with NMRA. |
Recommended only for this consignment. It is for research purpose and development purpose. |
88 |
1/12/2021 |
MD/382/12/2021 |
Duodena Video Scope |
|
Mediquipment Limited |
Olympus Medical System Corporation - Japan |
Repaired Items |
- |
Recommended only for this consignment. |
89 |
1/12/2021 |
MD/400/12/2021 |
QIA Cube HT / QIAxtractor , Platform |
1 |
Microtech Biological (Pvt) ltd |
QIAGEN GmbH - Germany |
For Health System Enhancement Project (To Apeksha Hospital, Maharagama) |
Manufacturer already registered with Microtech Biological (Pvt) ltd. |
Recommended only for this consignment. |
90 |
22/11/2021 |
MD/403/12/2021 |
EXT120-U Ozone Generator |
|
Rajarata University of Sri Lanka |
Longevity Resources - Canada |
For the study. |
- |
Recommended only for this consignment. |
91 |
30/11/2021 |
MD/409/12/2021 |
Multifilter ate Machines |
5 |
Fresenius Medical Care |
Fresenius Medical Care - Rusia |
To Re-Export |
- |
Recommended only for this consignment. (to export) |
92 |
7/12/2021 |
MD/427/12/2021 |
Continuous Renal Replacement Therapy Device |
1 |
Diligence Healthcare (pvt) ltd |
Indomed SA - Switzerland |
DGHS - Southern Province |
Manufacturing site changed from Switzerland to Plant. Legal manufacturer is Same. |
Recommended only for this consignment. |
93 |
7/12/2021 |
MD/428/12/2021 |
Ventilator Spare Parts |
2 |
Diligence Healthcare (pvt) ltd |
Zoll Medical Corporation - USA |
|
Manufacturer already registered with NMRA. |
Recommended only for this consignment. |
94 |
15/11/2021 |
MD/347/11/2021 |
Medical Equipment |
|
University of Colombo |
Thermofisher Scientific |
Donation to University of Colombo |
- |
Recommended only for this consignment. |
95 |
11/11/2021 |
MD/344/11/2021 |
Medical Equipments |
17 |
Medical Research Institute |
VWR International CmbH - Austria |
Donation by WHO to MRI |
- |
Recommended only for this consignment. |
96 |
22/11/2021 |
MD/354/11/2021 |
Respiratory Syncytial Virus Freeze dried powder in glass vial / Respiratory Syncytial Virus Controls dried powder in glass vial |
14 |
Medical Research Institute |
NEQAS - UK |
Donation to MRI |
- |
Recommended only for this consignment. |
97 |
22/11/2021 |
MD/355/11/2021 |
Voltage Stabilizer |
312 |
Medical Supplies Division |
United Nation Children Funds (UNICEF) |
Donation to MSD |
- |
Recommended only for this consignment. |
98 |
29/11/2021 |
MD/368/11/2021 |
Fingertip Pulse Oximeter |
1,050 |
Medical Supplies Division |
Guangdong Weishan Technology Co.ltd - China |
Donationa to MSD |
- |
Recommended only for this consignment. |
99 |
25/11/2021 |
MD/369/11/2021 |
Medical Equipments |
162 |
Medical Supplies Division |
UNICEF |
Donation to MSD |
- |
Recommended only for this consignment. |
100 |
11/11/12021 |
MD/345/11/2021 |
Laboratory Oven 256Lt, Laboratory Oven Shelves, A-Acetyl-L-Cysteine 100g |
42 |
National Programme forTuberculosis Control & Chest Diseases |
DE - Germany |
Donation to NPTCCD |
- |
Recommended only for this consignment. |
101 |
19/11/2021 |
MD/366/11/2021 |
Vitrification Solution Set 110 & Warming Solution Set 205-80 Sets / Cryotec (10 Pieces) - 100 Sets |
80 + 100 |
Vindana Reproductive Health Centre (Pvt) ltd |
Reprolife - Japan |
For Assisted Reproductive Services |
- |
Recommended only for this consignment. |
102 |
9/9/2021 |
MD/10/09/2021 |
Nucleic Acid Extraction Kit C32 test, 96 test) |
100000 |
Avon Pharma Chem (Pvt) ltd |
Zybio INC - China |
|
Already file submitted and registration is recommended by Sri Lanka College of Microbiology. NMRA still not issued the certificate. Due to the agency transfer continue us discussion. |
Recommended only for this consignment. (As per the letter given by the NMRA WOR.) |
103 |
19/11/2021 |
MD/360/11/2021 |
Micromanipulation Pipettes (ICSI Pipettes / Holding Pipettes) |
182 |
A. Baur & Co. (Pvt) ltd |
Vitrolife Inc - USA |
For Several Hospitals |
Manufacturer Not Registered with NMRA. WOR issued on September |
Recommended only for this consignment. |
104 |
610/2021 |
MD/208/10/2021 |
Neogen Culture Media |
12 |
Mediding (pvt) ltd |
Neogen Corporation - USA |
For Coconut Development Authority |
- |
Recommended. Issue Product Categorization. |
105 |
6/10/2021 |
MD/218/10/2021 |
Oxygen Regulator |
20 |
Gas Connect (pvt) ltd |
Danyang Lovetec Value Co.ltdd - China |
|
|
Recommended only for this consignment. Apply for registration. Sample tested by BMES and Pass. |
106 |
6/10/2021 |
MD/214/10/2021 |
Oxygen Regulator |
100 |
Silkroad Traders Hub (Pvt) ltd |
Shenzhen Great Fruit Supply Chain Co.ltd - China |
Donation for Several Hospitals |
|
Recommended only for this consignment. Apply for registration. Sample tested by BMES and Pass. |
107 |
17/09/2021 |
MD/70/09/2021 |
Oxygen Concentrator (DO2-5AH) |
5 |
Medisurg International |
Kunshan Dymmed Medical Technology Co.ltd |
Staff use |
|
Recommended only for this consignment and apply for registration. Sample tested by BMES and Pass. |
108 |
7/9/2021 |
|
Oxygen Concentrator (Model- SD/05B, SD/05W) |
100 |
PCL Solotions (Pvt) Ltd |
Jiangsu Shuangsheng Medical Appliance Co.ltd - China |
|
|
Recommended only for this consignment and apply for registration. Sample tested by BMES and Pass. |
109 |
17/09/2021 |
|
Pulse Oximeter (Model-C101A2) |
2000 |
Metro Serandib (Pvt) ltd, |
Shenzhen IMDK Medical Technology Co.ltd - China |
|
|
Recommended only for this consignment. Sample tested by BMES and Pass. |
110 |
17/09/2021 |
|
Pulse Oximeter (Model-C101A2) |
200 |
J.G.K. Kavinda Hashan |
Shenzhen IMDK Medical Technology Co.ltd - China |
|
|
Recommended only for this consignment. Sample tested by BMES and Pass. |
111 |
17/09/2021 |
|
Pulse Oximeter (Model-C101A2) |
200 |
T.H. Rasanga Laksri Tharuka |
Shenzhen IMDK Medical Technology Co.ltd - China |
|
|
Recommended only for this consignment. Sample tested by BMES and Pass. |
112 |
6/9/2021 |
|
Pulse Oximeter (Reelom Oximeter - ROX-1111) |
100000 |
Junaht International Pvt ltd, |
Vizin India Pvt ltd- India |
|
|
Recommended only for this consignment. Sample tested by BMES and Pass. |
113 |
10/12/2021 |
MD/430/12/2021 |
Shipment Items |
|
Ethics Review Committee, Facalty of Medicine, University of Colombo |
Lajolla Institute of Immunology - USA |
|
|
Recommended only for this consignment. |
114 |
10/12/2021 |
MD/432/12/2021 |
Home Defibrillator |
|
Lanka Jathika Sarvodaya Shramadana Sangamaya |
|
|
|
Recommended only for this consignment. |
115 |
11/11/2021 |
MD/351/11/2021 |
Spacer Device for Metered dose inhaler - AEROSPACER PLUS |
120,000 |
Emerchemie NB (Ceylon) Limited |
Taian Dalu Medical Instruments Co.ltd - China |
SPC Order |
Registration is valid until march 2022. WOR not necessary. (D/1356) |
WOR not necessary at the product has valid registration. |
116 |
1/12/2021 |
MD/391/12/2021 |
Ring Pessary |
19,912 |
Thusitha Rajapaksha, Sunshine Healthcare Lanka Ltd |
Cooper Surgical Inc - USA |
SPC Order |
- |
Recommended only for this consignment. Allowed WOR approved to clear balance stock. |
117 |
1/12/2021 |
MD/399/12/2021 |
Linear Cutter Device 100mm length,4.8mm height (Green) Sterile, Cartridges for Linear Cutter Device 100mm length, 4.8mm height (Green) Sterile) |
666 |
A. Baur & Co. (Pvt) ltd |
Covidien Pvt Ltd - USA |
SPC Order |
Agency transfer from Ceyoka (pvt) ltd to A. Baurs Co. (pvt) ltd is under processing. Not given by Ceyoka for agency transfer. |
Recommended only for this consignment. |
118 |
7/12/2021 |
MD/425/12/2021 |
Denture Flask & Clamp |
27 |
Rivomed Holdings (Pvt) ltd |
Silfradent Srl - Italy |
SPC Order |
Manufacturer not registered with NMRA. |
Recommended only for this consignment. Product need to be registered as listed item for future supply. |
119 |
8/11/2021 |
MD/309/11/2021 |
DNA Whole Blood Kit |
54 Kits |
Emar Pharma (Pvt) ltd |
RBC Bio Science Corp - Taiwan |
SPC Tender |
Manufacturer not registered with NMRA. |
Recommended only for this consignment. |