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RDC 754/2022 — Labelling Requirements

RDC 754/2022 — Labelling, Marking & Instructions for Use

RDC 754/2022 establishes comprehensive labelling and instructions for use (IFU) requirements for all medical devices placed on the Brazilian market. All labelling text, markings, and instructions must be in Brazilian Portuguese, though multilingual instructions are permitted if Portuguese is primary.

Key mandatory label elements:

  • Device name and description

  • ANVISA registration number (Reg. ANVISA:)

  • Manufacturer name and address

  • Importer name and address (for imported devices)

  • Lot/batch number (Lote:)

  • Manufacturing date

  • Expiry date (where applicable)

  • Sterilisation method and "ESTÉRIL" marking (for sterile devices)

  • Single-use indicator ("USO ÚNICO" or do-not-reuse symbol)

  • Storage conditions

  • RDC 754/2022 — ANVISA

Official sources

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