Guidance Documents — By Topic
ANVISA publishes several types of non-binding guidance documents to help industry understand and apply its regulations. This page provides an index of guidance by regulatory topic.
Types of ANVISA guidance
| Document type | Description |
|---|---|
| Nota Técnica | Technical note — ANVISA's official interpretation of a specific regulatory question |
| Perguntas e Respostas (Q&A) | Frequently asked questions and official answers |
| Guia | Guidance guide — step-by-step guidance on a specific process (e.g., Peticionamento Eletrônico) |
| Manual | Operational manual for a system or process |
| Consulta Pública response | ANVISA's published response to comments received during a public consultation |
Key guidance documents by topic
| Topic | Document type | Source |
|---|---|---|
| Classification of medical devices | Nota Técnica, IN 57/2022 (catalogue) | ANVISA GPRODS |
| Peticionamento Eletrônico user guides | Guia | ANVISA portal |
| Clinical evidence requirements | Nota Técnica | ANVISA GPRODS |
| GMP/CBPF requirements | Guia | ANVISA |
| Adverse event reporting (NOTIVISA) | Guia, Q&A | ANVISA |
| Labelling requirements | Q&A, Nota Técnica | ANVISA |
| IVD performance evaluation | Nota Técnica | ANVISA |
| SaMD / digital health | Nota Técnica | ANVISA |
Finding ANVISA guidance documents
All ANVISA guidance documents are available on the ANVISA website (gov.br/anvisa). Guidance documents are typically found under Assuntos → Produtos para Saúde → Regulamentação. Use the search function with keywords in Portuguese for best results.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.