Medical Device Registration and Approval in Brazil

General country-specific regulatory information is provided on this page for medical device registration and approval in Brazil. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Brazil, to expedite the preparation of your medical device or IVD registration application.

 

Medical Device Regulations and Classification in 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.

 

Other South American Countries:

Argentina, Chile, Colombia, Ecuador, Peru, Uruguay, Venezuela

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