Colombia
Regulatory Overview for Medical Device Registration in Colombia.
Authority
Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA).
Quality system
ISO 13485:2016
Classification
Class: I, IIa, IIb, III
Medical Devices are subject to registration with INVIMA.
The registration holder (Health Permit) is the Manufacturer even if it does not have a registered office in Colombia.
To register Medical Devices, it is mandatory to appoint an Importer.
Once registration has been obtained, the manufacturer and importer must submit periodic Technovigilance reports, reporting quarterly to the National Technovigilance Program any adverse events or incidents.
Applicant
Manufacturer
Colombian Legal Representative.
Timeframe and fees
Timeframe: 3 – 9 months.
Validity
10 years
Labelling and documentation language
Documentation Language and Labelling
All documentation must be submitted in Spanish.
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Disclaimer
The information on this page is valid and current as of October 2024. 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.
