Reliance Pathway
LK-Unique · Introduced October 2025 · Reference country recognition
Overview
From October 2025, the NMRA operates a Reliance Pathway enabling faster registration for devices that already hold approval from a recognised reference country regulatory authority. The pathway applies to Class I, IIa, and IIb devices. Class III devices continue to require full MDEC review.
Accepted Reference Countries
General Medical Devices:
| Reference Authority | Jurisdiction |
|---|---|
| FDA (CDRH/CBER) | United States |
| MHRA | United Kingdom |
| TGA | Australia |
| Health Canada | Canada |
| PMDA | Japan |
| EU Notified Body (CE marking) | All EU member states |
| Norwegian Medicines Agency | Norway |
| Swissmedic | Switzerland |
IVD Medical Devices (additional):
| Reference Authority | Jurisdiction |
|---|---|
| HSA | Singapore |
Eligibility Requirements
To qualify for the reliance pathway:
- Device holds a current, valid approval from an accepted reference authority
- The device submitted to NMRA is identical to the reference-approved device in: intended purpose · materials · specifications · design
- Technical specifications submitted to NMRA match those submitted to the reference NRA
- NMRA reserves the right to require full review if safety concerns exist
Documentation for Reliance Route
The reliance application uses a reduced version of the Consolidated Dossier (F-MDR-035), focusing on:
| Document | Requirement |
|---|---|
| Evidence of reference country approval | Current approval letter / registration certificate |
| Declaration of identical specifications | Written declaration from MAH/manufacturer |
| Device description | Summary confirming identity with reference submission |
| NMRA-specific documents | Sri Lanka labelling, MAH details, manufacturing site information |
| QMS evidence | ISO 13485 certificate |
| Essential requirements compliance statement | Simplified form |
Reliance Process
- Confirm eligibility (current reference approval + identical device)
- MAH prepares reduced dossier
- Submit to NMRA Medical Devices Regulatory Division
- NMRA conducts reliance review (shorter timeline than full review)
- Registration Certificate issued
Class III — MDEC Still Required
Even with reliance, Class III devices require MDEC review. The reliance pathway reduces the documentation burden but does not bypass the MDEC's expert advisory function for high-risk devices.
Strategic Value
If your device holds FDA 510(k)/PMA, CE marking, TGA registration, or similar, the reliance pathway can save 2–4 months compared to the full registration route. For a manufacturer entering Sri Lanka after major reference markets, this is typically the recommended pathway.