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

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.



Interested in obtaining fast market approval for your medical device or IVD in Colombia? REQUEST A FREE QUOTE>

For more information on registration in Colombia, check out the following articles on our blog:
Country at a Glance: Colombia
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