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 (Vigilância Sanitária Estadual/Municipal) registration and addition to federal AFE, depending on the state or municipality where the importer is located.
- AFE issued and published in DOU.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.
Quality Assurance Plan, Description of quality assurance procedures for imported products, including receipt inspection and storage conditions