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Inspection

  1. Machinery, medical equipment and devices:

 

  • Human medical devices 

    • in-vitro diagnostics;

      •  Medical equipment;

      • Ionizing radiation emitting medical equipment and devices;

      • Artificial intelligence-enabled diagnostic and therapeutic devices;

  1. Coordinating with relevant technical divisions and committees to facilitate the scientific assessment and regulatory decision-making process for market authorization applications.

  2. Assessing applications for variations, renewals, and other post-market authorization amendments to registered products and making recommendations for regulatory action.

  3. Maintaining accurate and up-to-date records of products granted Marketing Authorization and ensuring the integrity of the official product register.

  4. Establishing and publishing a list of prohibited substances and products.