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.
* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.
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