Medical devices sold in Brazil must register with the ANVISA who is responsible for all registration and inspection function within the agency.
Along with growing population reaching 210 million, Brazil represents the largest market in South America for medical devices, healthcare services and also one of the largest worldwide.
Within the world’s top 10 economies, Brazil has a very mature regulatory program in place. Brazil is a member of the Southern Common Market, also known as MERCOSUR, which partially regularizes the regulations with Argentina, Paraguay and Uruguay. All medical devices sold in Brazil must register with the AgênciaNacional de
VigilânciaSanitária (ANVISA), which is essentially an independently administered, financially autonomous regulatory agency responsible for the regulation and oversight of all medical devices. ANVISA maintains the registered products database and performs all registration and inspection functions within the agency.
Companies needs to be based in Brazil to register with ANVISA, so companies exporting to Brazil must operate with an in-country entity, for example distributor or dealer.
Device classification in Brazil is based upon risk that is similar to that applied in the European Union. Class I and II devices have a relatively easy application process that sometimes varies depending upon device use.
Higher risk devices could be needed to provide all or some of the following documentation with their application:
Free sales certificate (it may be substituted with the INMETRO certificate when applicable) or Certificate of Good Manufacturing Practice (GMP) or Instructions manual in Portuguese or Labeling and packaging or Letter from the device manufacturer, authorizing a Brazilian company to keep the product registration and distribute a device or Clinical trials (occasionally can be substituted with the INMETRO certification proving the overall effectiveness of the device.
Also, for some devices, for instance implantable medical devices, cardiovascular products, high-risk IVDs, dialysis devices and individual hearing aid systems, using economic Information report and INMETRO certification, when applicable.