Regulatory Authority

Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA).


I, IIa, IIb, III

Quality system

ISO 13485:2016

Medical Devices and IVDs are subject to registration procedure, so Medical Device must be registered with INVIMA in order to be marketed in Colombia.

Foreign manufacturers intending to market their devices in Colombia must appoint a Legal Representative in Colombia, that will be responsible for the registration process and the submission of the documentation at INVIMA.


Local Legal Representative.

Timeframe and fees

Timeframe: 3 – 9 months.


10 years

Labelling and documentation language

Documentation must be submitted in Spanish.

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