Medical Device Registration in
Venezuela
Ministry of Health
Ministry of Popular Power for Health (Venezuela)
Regulatory Authority
Servicio Autónomo de Contraloría Sanitaria (SACS)
Official Language
Spanish
Classification
Class I, II, III and IV
Medical Device Registration in Venezuela
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, are not intended for marketing.
All other medical devices must be registered with the OICEMP.
Determine the device classification
Appoint an Authorized Representative.
Prepare the Technical File and submit it to the concerned authority
Once approved, the device will be marketed in Venezuela
Documents Required
- Technical Documentation
- QMS certificate
- Application Form
- Labels, IFUs or User Manuals
Applicable QMS
Registration Timeline
1-2 months
Authorized Representative
Yes
License Validity
5 years
Special Notes
Documentation must be submitted in Spanish.