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Notas Técnicas — ANVISA Technical Notes Index

BR-unique

Notas Técnicas are ANVISA's official technical interpretation documents. They are not binding in the same way as RDCs, but they represent ANVISA's official position on specific regulatory questions and are closely followed by regulators and industry alike.

What Notas Técnicas cover​

Notas Técnicas are typically issued to:

  • Clarify how a new RDC applies to specific product types or situations;
  • Provide ANVISA's position on novel or emerging technologies (e.g., AI/ML SaMD, digital health);
  • Explain the classification of borderline products;
  • Provide guidance on clinical evidence requirements for specific device types; and
  • Respond to recurring industry questions not covered by Q&As.

How to find Notas Técnicas​

  1. Go to the ANVISA website at gov.br/anvisa.
  2. Navigate to Assuntos → Produtos para Saúde → Produtos para Saúde.
  3. Use the search function with the device type or topic (in Portuguese).
  4. Filter by document type "Nota Técnica."

Alternatively, search the DOU (Diário Oficial da União) at in.gov.br for ANVISA Notas Técnicas on specific topics.

Official sources

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