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, free of charge, 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, ChileEcuador, Peru, Uruguay, Venezuela

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