Medical Device Registration and Approval in Venezuela

General country-specific regulatory information is provided on this page for medical device registration and approval in Venezuela. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Venezuela, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in 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.

Other South American Countries:

Argentina, Brazil, Chile, Colombia, Ecuador, Peru, Uruguay

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