Regulatory Authority
1. Ministerio del Poder Popular para la Salud (MPPS); 2. Servicio Autonomo de Contraloria Sanitaria (SACS); 3. OICEMP. Medical Devices and IVDDs must be registered with the OICEMP.
Classification
There is no risk-based device classification. Devices are classified according to the use categories.
Quality system
ISO 13485:2016:2016 or ISO 9001
Some Medical Devices are exempt from registration, in particular: – devices imported into the country for testing by an accredited institute; – devices for research / study purposes, if requested by accredited institutions; – exhibition devices, not intended for marketing. All other Medical Devices must be registered with the OICEMP. Foreign manufacturers intending to market Medical Devices and / or custom-made devices in Venezuela must appoint a Local Representative responsible for submitting the documents required in the registration procedure to the OICEMP.
Applicant
Local Authorized Representative
Timeframe and fees
Timeframe: 1- 12 months Fees: no registration fee is provided. Validity 5 years
Labelling and documentation language
Documentation and labelling must be submitted in Spanish.
Useful information
The device which already obtained the FDA marketing clearance will be subject to a facilitated registration process to access the Venezuela market.
