Medical Device Registration in Brazil: How It Works, Key Steps, and ANVISA Insights
Medical device registration in Brazil involves classifying the device. Foreign manufacturers must appoint a Brazil Registration Holder (BRH) to work with ANVISA, the regulatory body. Some devices require INMETRO certification. Compliance also demands proper permits, such as an Operating Permit License (AFE). First, manufacturers must classify their devices according to their risk levels, which range … Read more