Registration in Colombia

CMC Medical Devices provides registration services for medical devices and IVD products in Colombia, supporting your entry into the market while ensuring compliance with local regulatory requirements. In Colombia, devices must obtain a sanitary registration from INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) before they can be marketed.

Registration involves submitting a complete dossier that includes product classification, technical and legal documentation, labeling in Spanish, and a Free Sale Certificate (FSC).

Users must also appoint a local authorized representative/holder to submit and manage the registration with INVIMA.

CMC can prepare and submit your registration dossier, assist with product classification, documentation and labeling compliance, FSC support, and act as your local representative throughout the process.

With CMC, you can introduce your products in Colombia with confidence and regulatory compliance.