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: Servicio Autónomo de Contraloría Sanitaria (SACS)

CLASSIFICATION SYSTEM: Medical Devices and IVDs: I/II/III/IV

TIMEFRAME:

New Registration:

20 working days (official timeline)

40 working days (based on experience)

SPECIAL REQUIREMENTS:

Audit: N/A

Local Tests/Permit: Local analysis is required by Ministry of Health and must be carried out by institutions accredited by MoH.

Clinical Evaluation or Studies: N/A

LOCAL FEES (New Application):

New registration (Class I): 1 Petro

New registration (Class II): 1.5 Petro

New registration (Class III): 1.75 Petro

New registration (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.

LOCAL FEES (Manufacturer): N/A

LICENSE VALIDITY: 5 Years

AUTHORIZED REPRESENTATIVE:  An Authorized Representative (AR) must be designated by foreign manufacturers to register medical devices in Venezuela.

Last updated on December 9, 2020.

Other South American Countries:

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

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