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 at 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. Note: ANVISA's website is frequently updated; if a document cannot be located using the navigation path provided, use the site search function as documentation may have been reorganized.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.