AFE — Autorização de Funcionamento de Empresa

BR-unique

The Autorização de Funcionamento de Empresa (AFE) is the company-level operating authorisation that every company engaged in the manufacture, import, export, distribution or storage of medical devices in Brazil must hold. There is no direct equivalent in the EU, US, AU, SG, or CA frameworks.

Who needs an AFE?

• Domestic manufacturers of medical devices;
• Importers of medical devices;
• Distributors and wholesalers of medical devices;
• Exporters of medical devices; and
• Companies that store medical devices on behalf of manufacturers or importers.

Healthcare facilities (hospitals, clinics) that use but do not distribute or manufacture medical devices do not require an AFE, but they do require a municipal Licença de Funcionamento.

Obtaining an AFE

1. Apply via Peticionamento Eletrônico on the ANVISA portal.
2. Submit required documentation: CNPJ, evidence of legal establishment, company activity description, site floor plan, Responsável Técnico details.
3. ANVISA processes the application and may conduct a documentation review.
4. State VISA endorsement may be required (varies by state).
5. AFE is granted and published in the DOU.

The AFE is specific to the activity type (manufacture, import, distribution) and the site address. Changes to site address or activity scope require a new AFE application.

• ANVISA — Peticionamento Eletrônico
• RDC 755/2022

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Official sources

Verify all information against official ANVISA sources before making regulatory decisions.