How to Read ANVISA RDCs & Portarias
BR-unique
ANVISA's binding regulations are issued as RDCs (Resoluções da Diretoria Colegiada) — resolutions of the Collegiate Board. Understanding how to navigate these documents is essential for regulatory professionals working in Brazil.
Structure of an RDC
| Section | Content |
|---|---|
| Preamble | Legal basis for the regulation (references to Lei 6.360, Lei 9.782, etc.) |
| WHEREAS clauses (Considerandos) | Justification for the regulation — regulatory rationale |
| Articles (Artigos) | The substantive regulatory requirements |
| Annexes (Anexos) | Technical annexes (classification rules, essential requirements, forms) |
| Transitional provisions | How the regulation applies to devices already registered under previous regulations |
Finding and accessing RDCs
- Diário Oficial da União (DOU): All RDCs are officially published in the DOU at in.gov.br.
- ANVISA legislation portal: Searchable index of all current ANVISA regulations at gov.br/anvisa.
- LegisWeb: Third-party database with consolidated versions of ANVISA regulations (subscription).
RDCs may be revoked (revogada) or amended (alterada) by subsequent RDCs. Always check the current consolidated version rather than reading an original publication that may have been amended.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.