Brazilian medical device registration requirements and procedures

Brazil's National Health Surveillance Agency, ANVISA (Agencia Nacional de Vigilancia Sanitaria) is part of the Brazilian Ministry of Health and is responsible for the pre - and post-marketing control of all medical devices, in vitro diagnostic products, food and pharmaceutical products.

ANVISA combines medical equipments, materials for health use, orthopedic implants and in vitro diagnostics are collectively referred to as medical devices.

ANVISA certification typically includes the following requirements and processes:

Classified into categories I, II, III or IV according to the degree of risk they pose to users, the registration information to be submitted is as follows:

a) Proof of payment of health supervision fee;

b) Application form for medical device registration;

c) Information used to identify manufacturers or importers and their medical devices;

d) Authorization documents of the manufacturer/producer/importer. With the authorization of the exporter, the importer shall explain the commercial relations between the producer and the exporter.

e) Risk assessment reports and safety data, including an assessment of possible damage and/or hazards;

f) Demonstrate compliance with the legal provisions contained in technical regulations, such as the ANVISA legislation regulating medical products.

g) Other required documents

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