REGULATORY AUTHORITY: Servicio Autónomo de Contraloría Sanitaria (SACS)
CLASSIFICATION SYSTEM: Medical Devices and IVDs: I/II/III/IV
TIMEFRAME: 20 to 40 working days
LICENSE VALIDITY: Licenses issued in Venezuela expire after five years.
LOCAL FEES (New Application):
- Class I: 1 Petro
- Class II: 1.5 Petro
- Class III: 1.75 Petro
- Class IV: 2 Petro
*All fees are indicated in Petro cryptocurrency, the correspondent value to other money must be done the same day of the payment to the SACS by using the virtual PETRO calculator.
LICENSE TRANSFER: License transfer is possible. In the SACS website all the Requirements and the correspondent Application Forms are listed case by case with the detailed information.
AUTHORIZED REPRESENTATIVE: An Authorized Representative (AR) must be designated by foreign manufacturers to register medical devices in Venezuela.
ADDITIONAL INFORMATION:
Both medical devices and IVDs intended to be marketed in Venezuela must obtain a Sanitary Registration Certificate from SACS prior to commercialization, unless they are included in the official list of products exempt from registration.
Registration is risk-based (Class I–IV); all classes follow the same registration pathway, but local quality analysis of samples is mandatory and must be conducted by institutions accredited by the Ministry of Health before registration approval.
