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.
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