Registration Maintenance
NMRA · Annual fees · USD-denominated · Change management
Annual Fees — LK-Unique USD-Based Schedule
The NMRA charges annual maintenance fees for registered devices. These fees are:
- Denominated in USD — set in US dollars, not Sri Lankan Rupees
- Converted at the monthly USD/LKR exchange rate published by the NMRA on its website
- Payable annually — non-payment can result in lapsing of the Registration Certificate
Current USD rate (May 2026): LKR 315.19 per USD — check the NMRA website for the current monthly rate before payment.
Fee Payment
Contact the NMRA Medical Devices Regulatory Division for the current fee schedule and payment process. Fees are typically paid in Sri Lankan Rupees at the prevailing USD rate.
Post-Approval Change Management
The MAH must notify the NMRA and obtain approval for changes to:
| Change Type | Notification Required |
|---|---|
| Device design, materials, or specifications | Yes — assess safety impact |
| Intended purpose or indications | Yes — may require re-evaluation |
| Manufacturing process or site | Yes |
| Major labelling changes | Yes |
| New variants or accessories | Yes — may require new registration |
| MAH details | Yes |
Variation Classification
Not all changes require the same level of NMRA review:
- Minor administrative changes (e.g., address change) — notification may suffice
- Technical changes with no safety impact — notification with supporting evidence
- Significant technical changes (new materials, new indications) — may require re-evaluation
Confirm the applicable variation type with the NMRA before implementing changes.
Renewal
Registration Certificates have a defined validity period (initially 1–2 years provisional, then renewable). Renew before expiry:
- Submit renewal application to NMRA
- Provide updated ISO 13485 certificate (must be current)
- Confirm no significant changes have occurred (or submit change application first)
- NMRA reviews and issues renewed Registration Certificate
- Apply for renewed Import Licence (if applicable)
Start renewal at least 4–6 months before expiry to allow for NMRA processing time.
MAH Transfer — Changing the Marketing Authorization Holder
If the Sri Lanka MAH changes:
- Submit a MAH transfer application to the NMRA
- Both outgoing and incoming MAH must cooperate in the transfer
- Incoming MAH assumes all regulatory obligations from the date of transfer
- Ensure there is no gap in valid Registration Certificate or Import Licence coverage during the transition
A gap in MAH coverage can interrupt commercial supply — plan transfers carefully and well in advance.