Skip to main content

Perguntas & Respostas (Q&As) by Regulation

BR-unique

ANVISA publishes Perguntas e Respostas (Q&As — questions and answers) for major regulations to help industry understand their practical application. These are the closest equivalent to FAQ documents published by FDA or TGA.

Where to find official Q&As​

ANVISA publishes Q&As on its website as part of the documentation package for each major regulation. Q&As are available for:

  • RDC 751/2022 — Medical device registration
  • RDC 752/2022 — GMP (CBPF)
  • RDC 753/2022 — Adverse event reporting and recalls
  • RDC 754/2022 — Labelling
  • RDC 755/2022 — AFE (Establishment authorisation)
  • RDC 36/2015 — IVDs

Submitting questions to ANVISA​

Industry may also submit questions to ANVISA via:

  1. Fala.BR — Brazil's official citizen complaints and queries platform (gov.br/falabr);
  2. ANVISA's online contact form — for specific regulatory queries; or
  3. Public consultations (audiências públicas) — for input on draft regulations.

ANVISA's responses to individual queries are not binding, but written responses from ANVISA can serve as useful evidence of ANVISA's interpretation of a regulation.

Official sources

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