AFE for Importers — Peticionamento Eletrônico Steps
Importers of medical devices in Brazil must hold a valid AFE (Autorização de Funcionamento de Empresa) specifically for import activities. The AFE is obtained via ANVISA's Peticionamento Eletrônico.
Required documentation for AFE (Importers)
| Document | Detail |
|---|---|
| CNPJ | Current CNPJ certificate from Receita Federal |
| Articles of incorporation | Contrato social or Estatuto social |
| Proof of address | Current proof of business address (water/electricity bill or lease agreement) |
| Responsável Técnico details | Name, professional council registration number |
| Activity description | Description of medical device types to be imported |
| Floor plan | Simple floor plan of the warehouse/storage area |
Process
- Log in to Peticionamento Eletrônico.
- Select "AFE — Importador de Produto para Saúde."
- Complete the online form and upload documents.
- Pay the AFE petitioning fee.
- ANVISA processes the application (2–4 months typical).
- State VISA endorsement may be required in some states.
- AFE issued and published in DOU.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.