Regulatory Insights
Medical device dossiers: using the revised NMRA checklist
A practical explanation of Sri Lanka's consolidated medical-device dossier process and the revised F-MDR-035 checklist effective 7 July 2026.
A dossier can be technically sound and still arrive at the accepting point in the wrong format. For a new medical device registration in Sri Lanka, the starting point is now the consolidated submission route and the current acceptance checklist of the National Medicines Regulatory Authority (NMRA), not the file used for a previous product.
What changed?
The NMRA introduced consolidated dossiers for new medical device applications from 5 August 2025. Instead of assuming that site and product matters always begin as separate applications, applicants must now prepare the consolidated dossier required for their circumstances.
The NMRA subsequently revised the F-MDR-035 document acceptance checklist (the Consolidated Dossier Submission Checklist for New Product Registration). Its notice advises Market Authorization Holders to submit consolidated dossiers in line with the revised checklist with effect from 7 July 2026. A file prepared using an older checklist may not reflect the current acceptance requirements.
The main dossier routes
The NMRA publishes two broad consolidated routes: FMSA + PRD, and PRD without FMSA. The first brings the relevant Foreign Manufacturing Site Application (FMSA) documentation together with the Product Registration Dossier (PRD) for general medical devices and in vitro diagnostic devices. The second applies where a PRD-only route is permitted: the NMRA lists it for general medical devices, in vitro diagnostic devices and listed devices, for both foreign and local manufacturers, and notes that listed medical devices are exempted from manufacturing site registration for foreign manufacturers.
Which route is applicable depends on the product, manufacturer and NMRA requirements. Applicants should avoid selecting a route only because the same company used it for a different product.
Why the acceptance checklist matters
The acceptance checklist is more than an administrative form. It helps ensure the dossier includes the relevant authorisations, manufacturing evidence, technical documentation, declarations and supporting information before submission. Consistency across documents is just as important as the presence of each document.
Examples of issues worth checking include mismatched manufacturer addresses, inconsistent model descriptions, expired certificates, incomplete labels and technical evidence that does not clearly correspond to the submitted device.
Other routes require separate attention
The NMRA publishes specific information on eligible low-risk devices and on reliance. Low-risk devices (listed devices, Class I general medical devices and Class A in vitro diagnostic devices within the scope of the NMRA's guideline GL-037, effective 13 May 2026) are submitted against a separate checklist, F-MDR-046. Under the reliance pathway (effective 29 October 2025), the NMRA's notice states that end-user evaluation is waived for eligible applications and that all other procedures, requirements and fees remain unchanged.
These routes have eligibility rules. An approval in another country or a Class I designation does not, on its own, establish that an application qualifies for a particular process.
Before preparing your file
Confirm the intended use, category, legal manufacturer, manufacturing site, local applicant, current checklist and applicable pathway. Then review the available documents against that route. If an item is missing or unclear, resolve it before finalising the application package.
How RAQ can assist
RAQ Consultation can review the proposed device range, help identify the relevant published procedure, assess document gaps and support dossier preparation and regulatory coordination with the appointed local applicant. The NMRA makes the final registration and licensing decisions.
Official references
- NMRA Medical Devices
- Consolidated Dossier Introduction
- Revised F-MDR-035 Notice
- Reliance Pathway Notice
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