National Medicines Regulatory Authority (NMRA) - Sri Lanka

The National Medicines Regulatory Authority (NMRA) is the statutory body in Sri Lanka responsible for the regulation and control of medicines, medical devices, borderline products, and cosmetics. Established under the National Medicines Regulatory Authority Act No. 5 of 2015, it operates under the Ministry of Health.

1. Regulatory Role

The NMRA serves as the central authority to ensure that all medical devices available to the public meet established standards of safety, quality, efficacy, and performance. It aims to protect public health by managing the risks associated with medical technology.

2. Key Functions and Responsibilities

• Registration of Medical Devices: No medical device can be imported, manufactured, or sold in Sri Lanka without prior registration with the NMRA.
• Licensing of Establishments: The NMRA issues licenses to manufacturers, importers, wholesalers, and retail pharmacies.
• Quality Assurance: The authority conducts inspections and audits of manufacturing facilities and storage sites to ensure compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
• Post-Market Surveillance: This involves monitoring the safety of devices once they are on the market, managing recalls, and investigating complaints.
• Clinical Trials: The NMRA regulates clinical trials involving medical devices to ensure ethical standards and participant safety.

3. Medical Devices Evaluation Committee (MDEC)

Applications for registration are reviewed by the Medical Devices Evaluation Committee (MDEC). This committee consists of experts who provide technical recommendations to the NMRA regarding the suitability of a device for the Sri Lankan market.

4. Classification

Medical devices are generally classified based on risk levels, following international guidelines (Class A, B, C, and D), which determines the depth of the evaluation process required for registration.