Sri Lanka Medical Device Registration: MAH, NMRA Review, and Reference Country Reliance

The regulation of medical devices and In Vitro Diagnostics (IVDs) in Sri Lanka is governed by the National Medicines Regulatory Authority (NMRA). To legally place a product on the market, foreign manufacturers must navigate a multi-step, complex registration pathway that necessitates appointing a local representative.

Key Requirements for Market Access

1. Local Marketing Authorization Holder (MAH)

Manufacturers must appoint a local Marketing Authorization Holder (MAH) to manage the regulatory process and serve as the legal entity responsible for the product in Sri Lanka.

2. Registration Process Overview

The overall registration process is lengthy, typically taking approximately 20–24 months to complete, and involves multiple sequential stages:

• Manufacturing Site Registration: This initial stage usually requires 7–8 months for approval.
• Sample Import License: A separate license application for samples, often reviewed and granted within 3–4 months.
• Full Registration Dossier Submission: The complete application is submitted to the NMRA and the Ministry of Health for review.
• Registration Approval and Import License: Granted upon successful final review by the NMRA.

3. NMRA Review Structure

Applications are reviewed by NMRA officers. Higher-risk devices are referred to the Medical Device Evaluation Committee, which meets by specialty (e.g., quarterly for surgery, monthly for anesthesia). The complexity of the review dictates the overall timeline.

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Reference Country Reliance (Reliance Pathway)

Sri Lanka utilizes a reliance pathway, recognizing regulatory approvals from established markets to expedite the review process. The NMRA accepts approvals from the following Reference Countries:

• United States
• European Union (EU)
• Canada
• Australia
• United Kingdom
• Japan

Devices that are already registered in one of these recognized markets may qualify for regulatory reliance. This reliance can potentially bypass the need for review by the expert evaluation panel for most device classes. However, Class III (High-Risk) products are typically still subject to review by the Medical Device Evaluation Committee, even with Reference Country approval.