The Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) is the authority responsible for medical device vigilance and quality control following Decree 4725/2005. The Colombian classification system is a risk based classification (Chapter II of Decree 4725/2005) and is subdivided in four classes (Class I, Class IIa, Class IIb and Class III), similar to the classification used in Europe. After submission is done and accepted by INVIMA, the manufacturer will receive a Sanitary Registry number that should be placed on the product label. One of the important documents that needs to be provided is the Free Sales Certificate (FSC) issued by the competent sanitary agency in the country of origin, legalized through consulate or apostille.
Local license holder
Companies without an establishment in Colombia are required to appoint a Colombian local representative. Both the importer as a separate Colombian legal representative can act as the local registration partner. The importer should be known at the moment of registration as an authorization document for import is part of the submission file.
Submission file needs to be set up in Spanish and even for professional use part of the information needs to be in Spanish.