Medical Device Registration in
Ministry of Health
Ministry of Popular Power for Health (Venezuela)
Servicio Autónomo de Contraloría Sanitaria (SACS)
Class I, II, III and IV
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
- Technical Documentation
- QMS certificate
- Application Form
- Labels, IFUs or User Manuals
Documentation must be submitted in Spanish.