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RDC 755/2022 — Establishment Authorisation (AFE)

RDC 755/2022 governs the Autorização de Funcionamento de Empresa (AFE) — the company-level operating authorisation required for all manufacturers, importers, distributors, and exporters of medical devices in Brazil.

Key provisions:

  • Who must hold an AFE (manufacturers, importers, distributors, exporters, sterilisation companies);

  • Requirements for each AFE type (documentation, facilities, Responsável Técnico);

  • Application process via Peticionamento Eletrônico;

  • Validity period and renewal requirements;

  • Changes requiring AFE update (change of address, addition of activities, change of RT); and

  • Consequences of operating without an AFE (interdição, fines, criminal liability).

  • RDC 755/2022 — ANVISA

Official sources

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