Who Needs to Comply?
Foreign Manufacturers
Foreign manufacturers cannot register devices with the NMRA directly. They must:
- Appoint a Sri Lanka-based MAH to manage registration and post-market obligations
- Register their manufacturing facility with NMRA (site registration is a prerequisite to product registration)
- Provide all necessary documentation to the MAH for the registration dossier
- Maintain manufacturing quality — ISO 13485 certification is required
Marketing Authorization Holder (MAH) — LK-Unique
The MAH is a Sri Lanka-based entity — company or individual — that carries the full regulatory burden for the device's presence in Sri Lanka. The MAH:
| Area | MAH Obligation |
|---|---|
| Registration | Submit and hold the Registration Certificate |
| Licensing | Apply for and hold the Import Licence |
| Quality failures | Receive, investigate, and manage quality complaints |
| Vigilance | Report adverse events to NMRA within required timeframes |
| Recalls | Initiate and coordinate FSCAs |
| Advertising | Obtain prior written NMRA approval for all device advertising |
| Fees | Pay NMRA annual maintenance fees (USD-denominated) |
| Renewals | Keep Registration Certificates and Import Licences current |
| Changes | Notify NMRA of post-approval changes to device or MAH details |
| Distribution | Oversee Sri Lankan distribution channels |
| NMRA cooperation | Assist NMRA inspections and investigations |
The MAH model means the local entity has significantly more legal exposure than a typical distributor. Manufacturers should vet potential MAHs carefully and ensure they have the technical capacity to fulfil these obligations.
Importers and Distributors
Once the MAH holds the Import Licence, commercial importation can proceed through appointed importers and distributors. The MAH retains regulatory accountability regardless of who physically handles the import and distribution.
Local Manufacturers
Sri Lanka-based manufacturers must also register their Class I, IIa, IIb, and III devices with the NMRA and hold the appropriate licences. Local manufacturers undergo NMRA GMP inspection of their manufacturing facilities.
Lifecycle of a Medical Device in Sri Lanka
| Stage | Action | Who |
|---|---|---|
| 1 | Classify device | Manufacturer + MAH |
| 2 | Register manufacturing facility | Manufacturer (NMRA site approval) |
| 3 | Apply for Sample Import Licence | MAH (if local testing needed) |
| 4 | Compile and submit Consolidated Dossier (F-MDR-035) | MAH |
| 5 | MDEC review (Class IIb/III) | NMRA/MDEC |
| 6 | Receive Registration Certificate | NMRA → MAH |
| 7 | Apply for Import Licence | MAH |
| 8 | Commercial importation and distribution | MAH/Importer |
| 9 | Post-market: vigilance, advertising approvals, annual fees | MAH |
| 10 | Renewal (before certificate expiry) | MAH |