Two Dossier Routes for Sri Lanka Device Registration: FMSA Plus PRD and PRD Only

1. Key takeaways

Sri Lanka’s device product registration dossier (the PRD, or Product Registration Dossier) can be filed through two submission routes. Route one is the full FMSA plus PRD route: the applicant first obtains the Foreign Manufacturing Site Approval (FMSA) for the overseas production site, and then proceeds with product registration. Route two is the PRD-only route, which does not require a separate site registration step and reviews the product documentation on its own. The core PRD documentation requirements are identical under both routes, so the real difference between them is whether the manufacturing site must pass through the approval stage before the product file can move forward.

• Route one (FMSA plus PRD) applies to general medical devices and IVDs under GL-034, which took effect on 23 July 2025.
• Route two (PRD without FMSA) applies to general medical devices, IVDs and Listed devices, and is open to both foreign and local manufacturers.
• Foreign manufacturers of Listed devices are exempt from manufacturing site registration under GL-034 and the NMRA medical device page.
• Both routes require submission of the same core PRD documentation set.
• Product-specific documentation is added according to product attributes, such as sterile, active, IVD or implantable status.
• The dossier structure combines general documents, the FMSA section where applicable, and the PRD section.

2. Legal basis

The two routes are grounded in guideline GL-034, which entered into force on 23 July 2025, and in the information published on the NMRA medical device page. The table below sets out how each route is defined, which products it covers, and how the dossier is assembled.

3. Expert insights

Insight one: choosing a route is essentially deciding whether the factory will be scrutinised. The FMSA plus PRD route means the foreign manufacturing site goes through document review and may face an on-site GMP inspection, while the PRD-only route skips that stage entirely. For a manufacturer entering Sri Lanka for the first time, the choice of route directly determines when the first order can land. The site stage adds lead time, coordination effort and inspection readiness work, so manufacturers should weigh it against their launch schedule from the very beginning rather than discovering the difference halfway through dossier preparation.

Insight two: Listed devices enjoy a structural exemption. The NMRA has stated explicitly that the Listed devices of foreign manufacturers are exempt from manufacturing site registration. This benefit is written into the rules themselves rather than being a discretionary concession left to the reviewer’s judgement. Because the exemption is structural, manufacturers of Listed devices can plan their projects on the assumption that no site application will be needed, and they do not have to argue for the exemption case by case. It also removes the risk of a site-level deficiency holding up the product file, since the site stage simply never opens for these products under route two.

Insight three: the core PRD checklist is shared by both routes. This means the documentation work does not differ in substance between the two routes. A manufacturer can complete the technical documentation according to the PRD checklist first and then decide which route to take. In practical terms, the PRD preparation effort is a sunk investment that remains valid whichever path is eventually chosen, which reduces the cost of keeping both options open during early planning.

A further consequence of the shared checklist is that switching routes late in a project does not discard the technical documentation already assembled. What changes with the route is only the site-side work: whether an FMSA application, a site review and a possible inspection must be slotted into the timeline. Manufacturers should therefore treat route selection and dossier preparation as two independent decisions that can be managed on separate tracks.

4. Practical recommendations

• Make the decision point early: first check whether the product falls within the low-risk list in Appendix 1 of GL-037, then check whether it holds approvals from recognised reference jurisdictions.
• If neither condition is met, schedule the project on the full FMSA plus PRD route and reserve time and budget for a GMP on-site inspection.
• Treat the two checks as a formal route decision node in the project plan, so the route is fixed before documentation work is completed rather than revisited afterwards.
• Prepare the core PRD documentation according to the shared checklist, since it stays the same under either route.
• Add the product-specific documentation only after the route decision, based on whether the product is sterile, active, an IVD or implantable.
• Document the rationale for the route choice in the project file, so that later deficiency responses and audits can show the decision was deliberate.

5. Verification checklist

• □ It has been decided whether the project follows the FMSA plus PRD route or the PRD-only route
• □ It has been checked whether the product is a Listed device (foreign manufacturers may be exempt from site registration)
• □ The core PRD documentation checklist has been prepared on the shared basis applicable to both routes
• □ Product-specific documentation has been added according to the product attributes (sterile, active, IVD, implantable)
• □ If the full route applies, time and cost for the GMP inspection have been reserved
• □ The route decision and its basis have been recorded in the project file

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including Sri Lanka. Our team prepares dossiers to NMRA expectations, manages submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com

Regulatory information verified as of 28 October 2026.