Brazil is the largest medical device market in Latin America and has a well-established but complex regulatory system. The Brazilian medical device market has an attractive potential – currently, it is worth approximately US$10.5 billion, and imported medical devices account for 80 percent of the market.

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ANVISA, the Brazilian Health Regulatory Agency, is responsible for monitoring medical devices, as well as drugs, pesticides, food, cosmetics, sanitizing agents, pharmaceutical supplies, blood, tissues and organs, pharmacies and drugstores, ports, airports and borders, and tabaco.

ANVISA keeps the Brazilian regulatory framework up-to-date at international level. In 2012 it co-founded the International Medical Device Regulators Forum (IMDRF).