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 a current, valid devices with existing reference approvals. 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.
Definition of 'Identical Device'
For reliance pathway purposes, the device submitted to NMRA is considered identical to the reference-approved device if: (1) the intended use, clinical indications, and patient population are the same; (2) design, materials, and manufacturing processes are unchanged; (3) technical specifications (dimensions, materials, electrical/mechanical properties) match exactly; and (4) labelling and instructions for use convey the same safety and performance information. Minor labelling differences (language, symbols) specific to the Sri Lankan market are acceptable if the technical and safety content is substantively identical.