Normative Instructions & Portarias
In addition to RDCs (Resoluções da Diretoria Colegiada), ANVISA issues:
Instruções Normativas (INs) — normative instructions that provide detailed operational requirements within the framework set by an RDC. Key medical device INs include:
- IN ANVISA 57/2022 — Classification catalogue for medical devices
- IN ANVISA 77/2021 — Classification catalogue updates
Portarias — ministerial orders issued by the Ministry of Health or ANVISA that may contain specific technical requirements or fee tables.
Notas Técnicas — technical notes issued by ANVISA providing guidance on specific topics (not binding, but ANVISA's official interpretation).
All ANVISA regulations are published in the Diário Oficial da União (DOU) and available on the ANVISA website.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.