Venezuela
REGULATORY AUTHORITY: 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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