Marketing Authorization Holder (MAH)
LK-Unique · Full cradle-to-grave regulatory accountability
What Is an MAH?
The Marketing Authorization Holder (MAH) is a Sri Lanka-based entity — company or individual — that is formally responsible to the NMRA for every aspect of a medical device's regulatory status in Sri Lanka. This role has broader accountability than a typical local representative or distributor.
Scope of MAH Responsibility
The MAH's accountability spans the full device lifecycle:
| Lifecycle Stage | MAH Obligation |
|---|---|
| Pre-registration | Arrange manufacturing site registration with NMRA |
| Registration | Submit Consolidated Dossier; manage NMRA queries; hold Registration Certificate |
| Import licensing | Apply for and hold Import Licence |
| Quality failures | Receive complaints; investigate with manufacturer; report to NMRA |
| Vigilance | Report adverse events to NMRA within required timeframes |
| FSCAs | Initiate, coordinate, and report FSCAs |
| Advertising | Obtain prior NMRA written approval for all device advertising |
| Fees | Pay annual NMRA maintenance fees |
| Renewal | Renew Registration Certificates and Import Licences before expiry |
| Changes | Notify NMRA of post-approval changes |
| Distribution | Oversee and manage Sri Lankan supply chain |
| NMRA cooperation | Assist inspections and provide records on request |
Who Can Be an MAH?
Any Sri Lanka-based entity (company or individual) with:
- Valid Sri Lanka business registration
- Sufficient technical and administrative capacity to fulfil MAH obligations
- Ability to maintain required records and communications
Common MAH arrangements:
- Local distributor acting as MAH
- Dedicated regulatory affairs company
- Locally registered subsidiary of the foreign manufacturer
MAH vs Importer
The MAH holds the regulatory approvals. The actual physical importation and distribution may be handled by the MAH directly or by appointed importers and distributors. The MAH retains regulatory accountability regardless of who handles logistics.
Selecting an MAH
Given the extensive obligations, manufacturers should carefully evaluate potential MAHs on:
- Regulatory affairs experience and NMRA relationships
- Technical understanding of the device category
- Financial stability (annual fees are payable by the MAH)
- Distribution capacity and network
- Track record with NMRA submissions and post-market compliance
Good Distribution Practice (GDP) — LK-Unique
The NMRA has expectations regarding Good Distribution Practice of Medical Devices (GDPMD) — standards for how registered devices are stored, transported, and distributed. The MAH is responsible for ensuring distribution activities comply with GDPMD requirements.
Currently, NMRA expectations are broadly aligned with WHO guidance on GDPMD. Anticipated formalisation of GDPMD requirements will introduce more explicit standards. The MAH should maintain:
- Appropriate storage conditions (temperature, humidity as required for the device)
- Traceability of device movements through the supply chain
- Qualified personnel for distribution activities
- Distribution records enabling device recall if required
Price Regulation — LK-Unique NMRA USD Rate Schedule
The NMRA publishes a USD-denominated fee schedule for annual registration maintenance. The applicable exchange rate is updated monthly on the NMRA website. MAHs must:
- Monitor the monthly rate
- Calculate fees at the applicable rate for the payment month
- Pay in Sri Lankan Rupees at the converted amount
Confirm the current fee schedule and payment process with the NMRA before making any payment.