Skip to main content

RDC 754/2022 — Labelling Requirements

RDC 754/2022 establishes the labelling requirements for medical devices placed on the Brazilian market. All labelling and Instructions for Use (IFU) must be in Brazilian Portuguese.

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.