CNPJ & ANVISA Company Registration
All entities operating as manufacturers, importers, distributors or exporters of medical devices in Brazil must hold a valid CNPJ (Cadastro Nacional da Pessoa Jurídica) — Brazil's company tax registration number, issued by the Brazilian Federal Revenue Service (Receita Federal).
The CNPJ is a prerequisite for:
- Registering on the ANVISA Peticionamento Eletrônico portal;
- Applying for an AFE;
- Registering medical devices (Registro, Cadastro, Notificação);
- Importing devices via SISCOMEX (the customs system); and
- Reporting on NOTIVISA.
Foreign companies wishing to manufacture, import or distribute medical devices in Brazil must either establish a Brazilian legal entity (Ltda. or S.A.) with a CNPJ, or work through a Brazilian distributor or importer who holds the CNPJ and AFE in their own name.
Unlike the US (which allows foreign establishments to register directly with FDA via a US agent) or the EU (which allows overseas manufacturers to place CE-marked devices on the market via an EU-authorised representative), Brazil requires the Brazilian entity (importer) to hold the ANVISA registration in their own name. This gives the Brazilian importer significant legal responsibility.
Verify all information against official ANVISA sources before making regulatory decisions.