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 rejected. 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.