Medical Devices

All dossiers and related applications for medical device registration shall be accepted in accordance with the following procedure.

• Submission of dossiers will be accepted every Tuesday from 9:00 a.m. to 3:00 p.m.    
• Submissions must be made at the Dossier Accepting Point, 2nd Floor, NMRA

Prior to physical submission, applicants must complete the online application form via the following link:
https://docs.google.com/forms/d/e/1FAIpQLSf8-B5VcCc1VXW7WL0fUhRiiap2BH6fQ6DvN2a2Yj1JpzLXig/viewform?usp=sf_link

Alternatively,applicants may scan the designated QR code to access the same form published in NMRA web site.

All applications for medical device registration must:

1. Be submitted following completion of the online Google Form
2. Include all required documentation as per NMRA guidelines
3. Be accompanied by the relevant checklist and supporting documents
4. Be submitted physically at the designated accepting point within the specified time

Incomplete submissions will not be accepted for evaluation.

The applicant (Marketing Authorization Holder) shall:

• Be fully responsible for the product and all information provided in support of the application
• Ensure the accuracy, completeness, and authenticity of submitted data
• Promptly inform NMRA of any changes related to:
  • Product information
  • Manufacturing process
  • Safety, quality, and effectiveness data
  • Regulatory status (e.g., rejection or withdrawal in other countries)
  • Current Good Manufacturing Practice (cGMP) compliance
• Provide additional data or clarification when requested during evaluation

PROCEDURE FOR CONSOLIDATED DOSSIER SUBMISSION ANDEVALUATION

FLOWCHART FOR CONSOLIDATED DOSSIER (FMSA + PRD)

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FLOW CHART FOR CONSOLIDATED DOSSIER (PRD ONLY)

There are two main types of consolidated dossiers for productregistration:

·      FMSA + ProductRegistration Dossier for General Medical Devices and IVDDs.  

·      Product RegistrationDossier without FMSA for General Medical Devices, IVDDs & Listed devices (Forboth foreign & local manufacturers)

***Listed Medical Devices are exempted from manufacturingsite registration for foreign manufacturers***

Process

• Verification of Submitted Documents

‍·      The applicant shall submit thecomplete consolidated dossier to the NMRA accepting point and the acceptingofficer shall verify the availability and completeness of documents inaccordance with the submission checklist prior to issuing the payment note.

• Processing of Payment‍

·      The accepting officer shallprocess the relevant payment based on; the type of application (SiteRegistration or Product Registration) and the information provided by the localagent in the Google form for medical device accepting.

• Payment Submission

·       The applicant shall submit the bank slip to theAccounts Division of NMRA and shall obtain the original payment receipt and ayellow receipt from the Accounts Division.

• Consolidated dossier submission with PaymentConfirmation

·       The applicant shall submit the consolidated dossieraccompanied by the yellow payment receipt, to the accepting point.

• Assigning a dossier number

·       The accepting officer shall verify the yellowreceipt issued by the accounts division and assign a dossier reference numberto the submitted dossier.

• Dossier Number Formats

·      Depending on the type of application, one of the following dossier number formats shall be used

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• Issuance of Acknowledgment

‍· Upon submission, the acceptingofficer shall issue an acknowledgment to the applicant, including the assigne dossier reference number.

• FMSA+ PRD Application

· Upon approval of the FMSA, the MDRD shall email the applicant a scannedcopy of the FMSA approval & if applicable attaching the approvedform (schedule IV form C and evaluation sheet) for processing SampleImport License (SIL)**. Theemail will also include the payment note for the Product RegistrationDossier (PRD).

·  In the case of rejection or awaiting data for FMSA, an evaluation sheet will be shared with theapplicant without a payment note.

·  The applicant shall make thepayment for PRD and submit the bankslip to the AccountsDivision of NMRA. After receiving the original payment receipt and a yellow receipt from theAccounts Division, the yellow receipt shall be submitted to the acceptingpoint.

·   The accepting officer shall issuean acknowledgment confirming receipt of the PRD payment note.

   **Applicable payments for issuance of the SILs will be handled by the NMRA Licensing division.

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• ‍ PRD Application without FMSA

· The MDRD shall email the scanned copy of the approved form (schedule IV form C and evaluation sheet) for processing Sample Import License (SIL) to the applicant, if applicable.

• ‍SIL Application Process (For Both FMSA + PRD and PRD Only Applications)

· The applicant shall submit a scanned copy of the approved form (schedule IV form C and evaluation sheet) to the Licensing Division of the NMRA, proceed with the SIL  payment, and submit the relevant payment slip to the Licensing Division for issuing the SIL.

· The applicant must submit a copy of the SIL & a request letter to initiate the evaluation process to the accepting point & the accepting officer shall issue an acknowledgment confirming receipt of the SIL copy.

• Reliance Pathway – Recognized Countries

             · For General Medical Devices, registration from the following countries will be considered under the reliance pathway:

                 USA, UK, Australia, Canada, Japan, Norway, Switzerland& All European Union (EU) member countries

            · For In Vitro Diagnostic(IVD) Medical Devices:

                 USA, UK, Australia, Canada, Japan, Norway, Switzerland, Singapore & All European Union (EU) member countries

• ‍ Stop-Clock Procedure

                 If deficient data or samples are requested:

                         · The applicant must submit the required information and relevant payment within two (2) months from the date of notification email.

                         · Submissions shall be made tothe accepting point.

• Final Approval and Licensing

                        · Approved PRD applications shall be forwarded to the Licensing Division for issuing and the Registration Certificate and Import License to the applicant.

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1 REQUIREMENTS WHICH NEED TO BE FULFILLED AT THESUBMISSION OF CONSOLIDATED DOSSIER APPLICATION

 1.1 Basic Requirements for Consolidated dossiers

·  Documents should be in a box file and a green tape should be pasted on the side of the box file.

·  In the front page of the box file must include the Generic Name, Brand Name, Manufacturer name & address, local agent, type of dossier (refer to the ‘dossier number formats’ in the guideline) &separate space should be allocated for the dossier number.

· All the pages of the documents should be numbered from bottom to top.

·  Index should be pasted on the inner side of the file indicating headings and correct page numbers.

·  Details of the responsible person for the regulatory affairs including the name, company details, designation, email ID, contact number should be available in the dossier.

·  Consolidated dossiers should be clearly separated as follows;

Type dossiers -‘FMSA  + PRD’ for General Medical Devices & IVDDs

General Documents - common administrative documents & common technical documents

Section 1 - documents required for FMSA application

Section 2 - documents required for PRD

Type dossiers -‘PRD without FMSA ’ for General Medical Devices & IVDDs for foreign & local manufacturers

General Documents – common administrative documents & common technical documents

Section 1 – documents required for PRD

1.2 Common administrative documents required for consolidated dossiers

Following documents are mandatory;

·      Letter of Authorization (LOA) from the legal manufacturer

If the legal manufacturer appointed more than one local agent, tabulated LOA including the details of all local agents, product range and manufacturing site should be submitted.

·      Declaration letter confirming the type of dossier from the local agent

·      Declaration letter confirming the submission of samples upon request of the authority

·      Agency transfer letter issued by NMRA (If applicable)

1.3  Common Technical documents required for consolidated dossiers

·      Valid Free Sale Certificate(FSC)  

For verification and confirmation purposes, original FSC or any other verification method (QR code, web link etc.) should be provided at the time of writing the processing fee.

·      Copy of GMP report issued by the NMRA for local manufacturers (If applicable)

·      Copy of FMSA approval issued by NMRA or NMRA product registration certificate as evidence.

·       ISO quality management system certificate

For Listed device - (ISO 13485:2016/2021 or ISO9001:2015)

Medical devices (except Listed Device) - ISO13485:2016/2021)

·      Foreign country registration evidence documents (Product registration certificate or FSC issued by the relevant health authority)

1.4  Documents required for the FMSA application + PRD

 Following documents should be submitted for FMSA application.

          ●     Application form for FMSA

          ●     Copy of Business Registration of the authorized local agent

          ●     Copy of Board of Directors’ Registration of the authorized local agent (if applicable)

          ●     Company Registration (Form 01/15/40)

          ●     Declaration letters

                     o      Declaration from manufacturer for local representation, manufacturing site status, readiness for inspection and accuracy of submitted documents

                     o      Declaration letter from local regulatory Pharmacist/qualified person stating that information given in this application is correct            

                     o      Declaration letter from legal manufacturer mentioning the details of other manufacturing sites belong to the legal manufacturer which are not included in the application

                     o      Consent Letter from local agent to withdraw the application when the NMRA noticed duplications

        ●     Site Master File (SMF) - Site Master File should be submitted along with all the applications for FMSA of Medical Devices.

Note: It is required to submit information as per the NMRA requirements for Site Master File (Refer NMRA website)

        ●     List of exporting countries

 Following documents should be submitted forPRD application.

       ·     Application form for Sample Import License  (Form C)

       ·     Application Form (Form A)

       ·     Application Form (Form B)

       ·     Device Details from the manufacturer

       ·     Manufacturer declaration of conformity/ EC full quality assurance system certificate/ EU quality management system certificate or manufacturer EC declaration of conformity

      ·     If CE marked medical devices: EC design examination certificate (If applicable)

      ·     Summary Technical Documentation (STED) – refer GHTF guidelines

      ·     Essential Requirement Check list – refer GHTF guidelines

      ·     Risk Analysis Report (Eg: ISO 14971 standard)

      ·     Certificate of Analysis (COA)/ finished product test report/ final product inspection test report

      ·     Stability protocol with data report (if applicable)

      ·     For Sterile medical devices;

           o  Sterility report

           o  Sterilization validation protocol with report

           o  EO residual test data for EO sterilized products

           o  Package Integrity data report

      ·     Biological evaluation report (if applicable)

      ·     Clinical evaluation test report (if applicable)

      ·     For active medical devices; Electrical safety data and Electromagnetic Compatibility data report (Eg: IEC standard)

      ·     For medical devices with measuring function; certification on medical devices, metrology or equivalent

      ·     For radiation emitting medical devices; Atomic Energy Authority Approval certificate

      ·     Third party test report (If applicable)

      ·     Software Verification and Validation Report (If applicable)

      ·     For devices containing biological material; a list of all materials used in the medical device and its manufacturing process that come from animal, human, microbial, or genetically modified (recombinant) sources.

      ·     Bovine Spongiform Encephalopathy (BSE) report(If applicable)

      ·     Product labels (Original/ artwork/ draft)

      ·     Product catalogue or brochure

      ·     For IVDD; Performance evaluation test report(Eg: Analytical , clinical)

      ·     Instructions For Use (IFU) (If applicable)

      ·     Patient Information Leaflet in Sinhala, Tamil& English languages for the point of care medical devices

      ·     List of standard accessories, reagents and consumables (If applicable)

1.5 Documents related to the PRD application - without FMSA

Please refer to Section 8.4: ‘Documents Required for PRD Application’ for the list of documents applicable to the above-mentioned type of dossier.

Validity Period of Registration

• Provisional Registration:

         o Issued for first-time registration

         o Valid for one (01) year or two (02) years, as specified in the certificate

• Full Registration:

         o Issued upon satisfactory evaluation

         o Valid for five (05) years, as specified in the certificate

Additional Data Requirements

• If additional information is requested by NMRA:

       o The applicant must submit the required data within two (02) months

Failure to comply may result in delays or rejection of the application.

Renewal of Registration

• Application for renewal should be made before six months from the date of expiry of registration. If additional information is requested by NMRA:

       o The applicant must submit the required data within two (02) months.

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