Medical devices are categorized into risk-based classes (Class A, B, C, and D), and the regulatory requirements vary accordingly. Foreign manufacturers must appoint a Local Authorized Representative (LAR) in Sri Lanka who acts as the official liaison with the NMRA. Additionally, the NMRA may accept approvals from recognized international regulatory bodies like the US FDA or European authorities to support the application and expedite the review process. Once registered, the product is subject to post-market surveillance, which includes reporting of adverse events, recalls, and regular compliance checks. The Sri Lanka Medical Device Registration framework is designed to ensure that only safe, high-quality, and effective medical devices are available in the country, aligning closely with global regulatory practices.
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- https://www.freyrsolutions.com.lk/medical-device-r
- Babae
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