Medical Device Registration and Approval in Colombia

General country-specific regulatory information is provided on this page for medical device registration and approval in Colombia. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Colombia, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Colombia

REGULATORY AUTHORITY: Medical devices are regulated by INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos).

CLASSIFICATION SYSTEM: Devices are classified according to risk, following the EU model of Classes I, IIa, IIb, III, and IV.

TIMEFRAME: The licensing process takes about 2-3 months for Class I and IIa devices, and 4-6 months for Class IIb and III devices.

LICENSE VALIDITY: Licenses for Class I and II devices expire after seven years; licenses for all other devices expire after five years.

AUTHORIZED REPRESENTATIVE: An authorized representative is required to register medical devices in Colombia.

Last updated on January 29 2015.

Other South American Countries:

Argentina, Brazil, Chile, Ecuador, Peru, Uruguay, Venezuela