Brazil
REGULATORY AUTHORITY: Medical devices are regulated by ANVISA (Agência Nacional de Vigilância Sanitária, or the Health Surveillance Agency)

CLASSIFICATION SYSTEM: Devices are classified according to a risk based model of Classes I, II, III and IV.

TIMEFRAME: 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. 

LICENSE VALIDITY: Licenses issued in Brazil expire after five years. 

AUTHORIZED REPRESENTATIVE: An authorized representative is required to register medical devices in Brazil.

Last updated on April 6, 2017.



ARE YOU INTERESTED IN REGISTRATION 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
 
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