Guidance & Resources
NMRA · F-MDR-035 · USD fee schedule · Application forms
Key NMRA Documents
| Document | Content | Where to Find |
|---|---|---|
| F-MDR-035 (Revised June 2026) | Consolidated Dossier Submission Checklist — mandatory format | NMRA website → Application Forms |
| Classification Guideline | EU-derived classification rules for general and IVD devices | NMRA website |
| Reliance Pathway Guidelines (Oct 2025) | Eligibility, reference countries, reduced dossier | NMRA website |
| Application forms | WOR, Site Registration, Sample Import Licence, Import Licence | NMRA website |
| Fee schedule | Annual maintenance fees (USD-denominated) | NMRA website |
| Advertising approval forms | Pre-approval application for device advertising | NMRA website |
USD Fee Schedule — Current Rate
NMRA fees are denominated in USD. The LKR equivalent is calculated at the monthly rate published on the NMRA website.
May 2026 rate: LKR 315.19 per USD
Check www.nmra.gov.lk for the current monthly rate before making any fee payment.
Official Source
All documents and latest forms: www.nmra.gov.lk → Medical Devices Regulatory Division
ISO Standards Summary
| Standard | Required For |
|---|---|
| ISO 13485:2016 | All registered devices — manufacturer QMS |
| ISO 14971:2019 | All registered devices — risk management |
| IEC 62304 | Software/SaMD |
| IEC 62366-1 | Usability engineering |
| ISO 10993 series | Devices with patient contact |
| IEC 60601-1 | Active/electrical devices |
Always use current checklist versions
F-MDR-035 was revised effective 2 June 2026. Previous versions are no longer accepted. Download a fresh copy for every submission.