During the Sesión Ordinaria 3 of last February, by mean of Acta no. 1, the Colombian Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) changed the risk class of the medical displays to IIa, and defined the application of the relevant pre-market procedure before marketing Medical Devices in the territory.
Importers and Manufacturers already marketing this kind of device in Colombia will have a six-month transitory period to comply with the new requirements.
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