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.
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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