Medical devices are regulated by the Servicio Autonomo de Contraloría Sanitaria (SACS). CLASSIFICATION SYSTEM:
Venezuela does not currently have a classification process for medical devices. TIMEFRAME:
Approval takes approximately three months. LICENSE VALIDITY:
The license expires at the same time as the first submitted document (FSC, LoA, ISO, etc.) AUTHORIZED REPRESENTATIVE:
An authorized representative is required to register medical devices in Venezuela.
Last updated on January 29 2015.
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