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Medical devices are regulated by ANVISA (Agência Nacional de Vigilância Sanitária
, or the Health Surveillance Agency)
Devices are classified according to a risk based model of Classes I, II, III and IV.
There are two different pathways for registration: cadastro
for Class I and II devices and registro
for Class III and IV devices. Approval takes only 4-6 months for the cadastro
process. For the registro
process, an ANVISA audit is required, after which registration takes an additional 8-10 months.
Licenses issued in Brazil expire after five years.
An authorized representative is required to register medical devices in Brazil.
Last updated on April 6, 2017.
Interested in obtaining fast market approval for your medical device or IVD in Brazil? REQUEST A FREE QUOTE>
For more information on registration in Brazil, check out the following articles on our blog:
Country at a Glance: Brazil
3 Ways Registration in Brazil is Improving
3 More Ways Registration in Brazil is Improving