Skip to main content

Portuguese Language Requirement

BR-unique

All labelling and Instructions for Use (IFU) for medical devices placed on the Brazilian market must be in Portuguese (Brazil). Labelling in English or other languages is not acceptable for Brazilian market access — a complete Portuguese translation is mandatory.

This applies to:

  • Outer packaging label;
  • Device label;
  • Instructions for use (IFU);
  • Promotional materials distributed in Brazil; and
  • Digital content (e.g., electronic IFU, app interfaces).

Translations must be accurate, complete, and readable. ANVISA reviewers will evaluate the Portuguese IFU and label as part of the Registro/Cadastro/Notificação review. Errors or omissions in the Portuguese translation can result in ANVISA deficiency questions (Exigências) or rejection.

Practical tips: Use a professional Brazilian Portuguese medical translator (not European Portuguese). Have the translation reviewed by a regulatory professional familiar with ANVISA labelling requirements before submission.

Official sources

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