Medical device registration in Venezuela

Venezuela

The information on this page is valid and current. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer


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 or ISO 9001

Procedure:
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.

Do you need support to market your devices in Venezuela?
CONTACT US

Applicant:
Local Authorized Representative

Timeframe and fees:
Timeframe: 1- 12 months
Fees: no registration fee is provided.

Registration validity:
5 years

Labeling and documentation language:
Documentation and labeling 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.

Questions? Request more info from our specialists
CONTACT US