Recent Regulatory Changes
NMRA · 2025–2026 developments
2026
Revised Consolidated Dossier Checklist F-MDR-035 — Effective 2 June 2026
The NMRA revised the F-MDR-035 Consolidated Dossier Submission Checklist. Key changes in the revised format:
- Updated documentation requirements aligned with current NMRA expectations
- Clearer section structure for reliance pathway applications
- Revised IVD requirements
- All applications submitted from 2 June 2026 onward must use this revised format
Action required: Download the revised F-MDR-035 from the NMRA website and use it for all new submissions. Do not use previous year's forms.
USD Rate (May 2026)
Current NMRA annual fee USD/LKR conversion rate: LKR 315.19 per USD (May 2026). Check monthly on the NMRA website for the current rate.
2025
Reliance Pathway — Introduced October 2025
The NMRA introduced the Reliance Pathway from October 2025, enabling faster registration for Class I, IIa, and IIb devices already approved in accepted reference countries.
Accepted reference countries: USA · UK · Australia · Canada · Japan · All EU member states · Norway · Switzerland (general devices) + Singapore (IVDs)
Benefits:
- Reduced dossier requirements — reference NRA's technical assessment leveraged
- Shorter NMRA review time compared to full registration
- Class III devices still require MDEC review regardless of reference country approval
Reliance eligibility check: Device must hold a current, valid approval from an accepted reference authority, and the device submitted to NMRA must be technically identical to the reference-approved device.
What to Watch in 2026
| Development | Status | Action |
|---|---|---|
| Further evolution of reliance pathway | Ongoing — NMRA may expand accepted reference countries | Monitor NMRA website |
| GDPMD formalisation | Under development | Monitor for new GDP guidance |
| Potential fee schedule revision | Annual process | Check NMRA website each year |
| MDEC procedural updates | Possible | Engage NMRA for Class IIb/III pre-submission queries |
Monitoring NMRA Updates
Stay current with Sri Lanka regulatory developments:
- NMRA website: www.nmra.gov.lk — check for circulars, revised guidelines, and new forms
- NMRA circulars to registered MAHs — ensure your MAH is subscribed
- Ministry of Health announcements: www.health.gov.lk
NMRA annual fees are due each year. Missing a payment can cause the Registration Certificate to lapse. Set calendar reminders well in advance of each annual fee payment date.