إجراء مقترح من كولومبيا: سلع من 4 فصول في النظام المنسق

The draft decree establishes the new sanitary regime applicable to medical devices for human use and in vitro diagnostic medical devices in Colombia, including provisions relating to manufacturing, importation, marketing, conditioning, storage, labelling, sanitary surveillance and conformity assessment. The measure incorporates a regulatory framework based on the risk level of medical devices and defines requirements applicable to the granting, amendment, renewal and cancellation of the corresponding sanitary authorizations. It also establishes provisions relating to Good Manufacturing Practices (GMP), Certificates of Storage and Conditioning Capacity (CCAA), G/TBT/N/COL/276- 2 - post-market surveillance, traceability, and the obligations of manufacturers, importers and other actors in the supply chain.The draft seeks to ensure the quality, safety and performance of medical devices with the objective of minimizing risks to human health and safety, as well as protecting persons who use such devices.