Market access in Brazil with ANVISA
Brazilian Medical Device Regulations
Brazil is one of the most interesting new export markets for medical device manufacturers in North America, Europe and Asia. As one the BRIC economies (Brazil, Russia, India and China) it represents significant market growth opportunities.
All medical devices in Brazil are regulated by the Brazilian Health Surveillance Agency (ANVISA). ANVISA requires that all devices must complete a device registration process. Non-Brazilian manufacturers need a local Brazilian Registration Holder (BRH) based in Brazil to submit technical files to ANVISA.
The Brazilian Regulation uses a risk-based classification system to classify devices into one of four groups: Class I (low risk) to Class IV (high risk). In addition, all of your manufacturing locations must comply with Brazilian GMP requirements (RESOLUÇÃO DA DIRETORIA COLEGIADA - RDC N°16, Brazilian regulations similar to ISO 13485).