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Before medical device manufacturers can legally sell their products in Brazil, they must be in compliance with Brazilian medical device regulations set forth by the Agência Nacional de Vigilância Sanitária (ANVISA).
In the ANVISA regulatory process, the first step in determining your path to compliance with Brazilian regulations is to ascertain the classification of your medical device in Brazil. This is done using a set of 18 rules found in Annex II of Brazilian RDC 185/01 published by ANVISA.
ANVISA's medical device regulations are based on the European Medical Devices Directive (93/42/EEC), so the classification rules tend to be similar to those used in Europe. However, they are not identical. Europe divides medical devices into Class I, IIa, IIb and III, whereas Brazil uses class I, II, III and IV. Again, it is vitally important to know the correct classification of your medical device prior to starting the ANVISA registration process.
Our team in Brazil specializes in medical device classification and registration and can help you determine the proper ANVISA classification for your medical device.