Sri Lanka Post-Market Surveillance: NMRA Market Control and MAH Obligations

Sri Lanka Post-Market Surveillance: NMRA Market Control and MAH Obligations

Post-Market Surveillance (PMS) for medical devices in Sri Lanka is a critical regulatory function overseen by the Market Control Division of the National Medicines Regulatory Authority (NMRA). The division's mandate is to ensure that only safe, effective, and high-quality products remain available to consumers throughout the entire supply chain.

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The Role of the NMRA Market Control Division

The Market Control Division has broad responsibilities covering the entire lifecycle of medical products after they are registered. Key activities include:

• Regulation of Imports: Ensuring that all imported medical products comply with Sri Lankan safety, quality, and regulatory standards.
• Market Surveillance Programme: Implementing monitoring programs to track product quality across the supply chain, detect risks, and verify ongoing efficacy and safety.
• Detection of Substandard or Falsified Products: Actively working to prevent unsafe or fraudulent products from circulating in the market.
• Product Recalls: Managing mandatory recalls from both the public and private sectors to efficiently remove defective or unsafe products.
• Post-Market Sampling: Conducting product sampling in collaboration with the National Medicines Quality Assurance Laboratory (NMQAL) to verify ongoing compliance against registration data.
• Inspections: Conducting Good Distribution Practices (GDP) Inspections of storage, handling, and distribution facilities.
• Public Engagement: Sharing regulatory updates, safety alerts, and recall notices with patients, healthcare providers, and retail outlets to ensure public safety.

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Responsibilities of the Marketing Authorization Holder (MAH)

The local Marketing Authorization Holder (MAH) serves as the legal entity responsible for the medical device and must maintain active participation in PMS. The MAH’s key obligations include:

1. Vigilance Reporting: Promptly reporting all adverse events and quality issues related to the medical device to the NMRA.
2. Record Maintenance: Maintaining accurate and detailed records of product distribution for complete traceability.
3. Regulatory Cooperation: Assisting the NMRA with formal investigations and coordinating mandatory product recalls when directed by the authority.
4. Distribution Compliance: Ensuring compliance with Good Distribution Practices (GDP) during the storage and transport of the medical device.

Active and immediate compliance with these PMS obligations is essential for the MAH to maintain the product's registration and legal status in the Sri Lankan market.