Regulatory Framework Overview
NMRA · NMRA Act No. 5 of 2015 · Two-step market entry
The National Medicines Regulatory Authority (NMRA)
The NMRA is an independent statutory body established by the NMRA Act No. 5 of 2015 under the Ministry of Health. It is governed by a multi-disciplinary board and managed by a Director General.
Internal Structure Relevant to Medical Devices
| Division / Body | Function |
|---|---|
| Medical Devices Regulatory Division | Registration applications, licensing, post-market surveillance oversight |
| Medical Devices Evaluation Committee (MDEC) | Expert advisory body for high-risk device applications (Class IIb/III) |
| Advertising Evaluation Sub Committee | Monthly review of advertising pre-approval applications |
| Market Control Division | Post-market surveillance, market compliance monitoring |
The Two-Step Market Entry Process — LK-Unique
Sri Lanka's market entry process is uniquely sequential:
| Step | Name | What It Authorises |
|---|---|---|
| 1 | Registration Certificate | Confirms device meets NMRA safety and performance standards |
| 2 | Import Licence | Authorises commercial importation for market supply |
Both steps must be completed before a device can be commercially supplied in Sri Lanka. The Registration Certificate alone does not authorise import for sale.
Additionally: A separate Sample Import Licence is needed to import test samples required for the registration process itself (e.g., for mandatory local testing of blood-contacting devices).
The MAH Model
All foreign manufacturers must appoint a Sri Lanka-based Marketing Authorization Holder (MAH). Unlike many markets where the local representative simply assists with submission, the Sri Lanka MAH holds full end-to-end regulatory accountability:
- Submitting and holding the Registration Certificate and Import Licence
- Post-market vigilance (adverse event reporting to NMRA)
- Recall coordination
- Advertising approval management
- Annual fee payment
- Distribution oversight
Foreign Facility Registration — Prerequisite
Before any product registration application can be submitted, the foreign manufacturing facility must be registered with and approved by the NMRA. This prerequisite — unique among Asian markets — requires a Site Master File (SMF) submission and may require an on-site audit or audit waiver evidence.
Reliance Pathway — From October 2025
Sri Lanka introduced a Reliance Pathway in October 2025, leveraging approvals from recognised reference regulatory authorities to enable faster registration for Class I, IIa, and IIb devices. Class III devices continue to require MDEC review even with reference country approval. See Reliance Pathway.
Regulatory Basis
The NMRA Act No. 5 of 2015 provides NMRA with authority to:
- Register and licence medical devices
- Issue, suspend, or cancel Registration Certificates and Import Licences
- Conduct facility inspections
- Require adverse event reporting
- Control advertising of registered devices
- Recall products that pose safety risks
- Set and collect fees (assessed in USD)