Regulatory Authority
Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA).
Classification
I, IIa, IIb, III
Quality system
ISO 13485:2016
The information on this page is valid and current as of January 2017. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer
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.
Applicant
Local Legal Representative.
Timeframe and fees
Timeframe: 3 – 9 months.
Validity
10 years
Labelling and documentation language
Documentation must be submitted in Spanish.
