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:
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
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.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.
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