Medical devices for human use, including in vitro diagnostic medical devices (IVDs), custom-made medical devices and adaptable medical devices. Components, parts, accessories and software, where they form part of a medical device, are used together with it or are specifically intended for its use. (HS codes: 3005; 3006; 38221; 401512; 9018; 9019; 9020; 9021; 9022)

Proyecto de Decreto "Por el cual se establece el régimen sanitario aplicable a los dispositivos médicos, se definen las reglas para su autorización de comercialización, vigilancia y control sanitario, y se dictan otras disposiciones" (Draft Decree establishing the sanitary regime applicable to medical devices, defining the rules for their marketing authorization, sanitary surveillance and control, and issuing other provisions); (99 pages, in Spanish)

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), 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.