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