Consolidated Dossier (F-MDR-035)
LK-Unique · All-in-one submission · Revised format effective 2 June 2026
What Is the Consolidated Dossier?
The NMRA uses a Consolidated Dossier approach — a single, comprehensive application package covering all aspects of device registration in one submission. The dossier structure is defined by the F-MDR-035 Consolidated Dossier Submission Checklist, published by the NMRA.
Important: From 2 June 2026, all submissions must use the revised F-MDR-035 format. Applications submitted after this date using the old format will be new on or rejected without NMRA review. Applicants with submissions in progress are advised to confirm the applicable format with NMRA early in the submission process. Download the current checklist from the NMRA website before preparing any submission.
Dossier Structure
| Section | Content |
|---|---|
| Administrative | Application type, MAH details, manufacturer details, device identifier, LRP information |
| Device description | Intended purpose, design description, materials, specifications, variants covered |
| Classification justification | Class assignment with reference to applicable NMRA classification rules |
| Essential principles compliance | Checklist mapping each NMRA essential requirement to compliance evidence (test reports, standards, declarations) |
| Risk management | ISO 14971 summary — hazard analysis, risk controls, residual risk evaluation |
| Clinical / performance evaluation | CER (general devices) or performance evaluation report (IVDs) |
| QMS evidence | ISO 13485 certificate — current, scope-appropriate, accredited CB |
| Labelling and IFU | Proposed Sri Lanka labelling (primary and secondary labels per NMRA Act §77) |
| Manufacturing site | Reference to NMRA-approved facility |
| Reference country approval | (Reliance route only) Current reference NRA approval documentation |
Sample Requirements — LK-Unique
For certain device categories, two product samples must be submitted as part of the registration:
Devices requiring samples:
- Blood-contacting devices (direct blood stream contact)
- Latex products (condoms, surgical gloves, examination gloves, bandages)
- Feeding bottles, toothbrushes
- Medical gas cylinders
To bring in samples before registration is complete, the MAH must first obtain a Sample Import Licence from NMRA.
Full vs Reliance Dossier
| Element | Full Registration | Reliance Route |
|---|---|---|
| Complete essential principles checklist | ✅ Required | Simplified version |
| Full clinical/performance evaluation | ✅ Required | Reference NRA evaluation accepted |
| Reference country approval document | Not required | ✅ Required |
| Device description | ✅ Full | ✅ Full |
| QMS certificate | ✅ Required | ✅ Required |
| Sri Lanka labelling | ✅ Required | ✅ Required |
Where to Get F-MDR-035
The current checklist is available on the NMRA official website: www.nmra.gov.lk → Application Forms → Medical Devices Regulatory Division.
Always download a fresh copy — do not use forms from previous years. The revised format from 2 June 2026 is the mandatory current version.
Fee Information
Consult the NMRA website (www.nmra.gov.lk) for current application fees associated with consolidated dossier submission. Fees vary by device class and submission route (full vs. reliance). Annual renewal fees are also applicable after initial Registration Certificate issuance.