To All Importers of Medical Devices
All importers of medical devices are hereby informed to submit following documents for the acceptance of new dossiers and re-registration dossiers of medical devices
Required documents for the new dossiers and re-registration dossiers of medical devices
Comprehensive table of content (Index)
Application form signed by authorized person (schedule 1 Form A/Form B)
Letter of authorization from legal manufacturer
Copy of foreign manufacturing site approval letter (If applicable)
Copy of GMP report issued by NMRA for locally manufactured products
Copy of sample license (for New)/ previous registration (for RR)
Original free sale certificate issued by relevant health authority
Hygienic certificate (If applicable)
ISO certificate
EC certificate
EC design examination certificate (If applicable)
COA/Finished product inspection report
Stability report with protocol & declaration of shelf life (If applicable)
Sterility report (If applicable)
EO residual test report (If applicable)
Electrical safety data report (If applicable)
Performance evaluation test report for IVD (If applicable)
Biological evaluation report (If applicable)
Third party test report (If applicable)
Bovine Spongiform encephalopathy (BSE) report (If applicable)
Atomic energy authority approval for radiation emitting devices
List of countries with evidence for other country registration
List of standard accessories, spare parts, reagent & consumables (If applicable)
Instruction for use (IFU) for IVD kits
Product labels-Original/Artwork/ Draft & product catalogue
(Date: 30 June 2023)