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

Registration Process

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

ISO 13485:2016

Registration Timeline

1-2 months

Authorized Representative

Yes

License Validity

5 years

Special Notes

Documentation must be submitted in Spanish.