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Notificação de Infração — Infraction Notices

An auto de infração (infraction notice) is a formal written notice issued by ANVISA or a state/municipal VISA inspector documenting a specific violation of health surveillance law and initiating the administrative penalty process.

When an auto de infração is issued​

Common grounds for an auto de infração in the medical device context include:

  • Manufacturing, importing, distributing, or selling a device without a valid ANVISA registration;
  • Operating without a valid AFE;
  • Non-compliance with GMP requirements (RDC 752/2022);
  • Failure to report adverse events via NOTIVISA within the required timeframe;
  • Non-compliant labelling (not in Portuguese, missing mandatory elements);
  • Failure to implement a recall ordered by ANVISA; and
  • Obstructing an ANVISA inspection.

The infraction notice process​

  1. ANVISA inspector identifies the violation and issues an auto de infração at the close of the inspection.
  2. The company has the right to present a preliminary defence (defesa prévia) within 10 working days of receipt of the auto de infração. The defence must address each alleged violation and may include evidence of correction, mitigation, or legal argument against the infraction.
  3. ANVISA reviews the defence and issues a decision.
  4. If a penalty is imposed, the company may file an administrative appeal (recurso) within 10 working days.
  5. Final administrative decision is published.
  6. If not resolved administratively, the company may pursue judicial review.
Official sources

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

After the first paragraph, add: "Penalties imposed following an auto de infração may include fines (multas), suspension of product registration, temporary facility closure, or other administrative sanctions. Penalty amounts are graduated based on device class, severity of violation, and company size. The specific penalty framework is defined in Lei 6.437/1977 and ANVISA implementing regulations."

"If no preliminary defence is filed within 10 working days, the infraction notice becomes administratively final. Similarly, if no administrative appeal is filed within 10 working days of ANVISA's decision, the penalty decision becomes final."