Andre40's List: ANVISA Product Registratio

• • Brazil
• Medical devices in Brazil are regulated by the Agência Nacional de Vigilância Sanitária (ANVISA). The regulations in Brazil, as well as the medical device classification schemes, are similar to those found in the European MDD 93/42/EEC. The first step in the process of registering a medical device in Brazil is, of course, to determine the classification of the device. This is critical for ensuring a smooth registration process. Once this has been confirmed, our team in Brazil can begin the ANVISA registration process.
• In our experience, the process of getting a Class I, II cadastre (i.e., low risk) application approved by ANVISA is approximately 3 to 4 months; and ANVISA approval for classes I-IV requiring GMP certification as part of the device application ranges from 6-12 months.
• We charge a flat-fee per device family for preparing an ANVISA registration and the price depends on the classification of your medical device. Registration certificates are valid for five years.

  • Belangrike registrasie vereistes om te ondersoek

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