ANVISA — The National Authority
BR-unique
ANVISA (Agência Nacional de Vigilância Sanitária) is a federal independent agency (autarquia) with its own budget, technical independence, and enforcement authority, created by Lei 9.782/1999.
What ANVISA is
ANVISA is Brazil's national health regulatory authority, responsible for:
- Regulating and supervising medical devices, drugs, cosmetics and other health products;
- Issuing regulatory acts (RDCs — Resoluções da Diretoria Colegiada);
- Granting product registrations (Registro), cadastres (Cadastro) and notifications (Notificação);
- Issuing Establishment Operating Authorisations (AFE); and
- Coordinating the SNVS with state and municipal bodies.
Key directorates for medical devices
| Directorate | Abbreviation | Responsibility |
|---|---|---|
| Gerência de Produtos para Saúde | GPRODS | Medical device classification and registration |
| Gerência de Avaliação de Tecnologias de Saúde | GGTPS | HTA and technology assessment |
| Gerência de Fiscalização | GFISC | Compliance and enforcement |
| Gerência de Biossegurança e Saúde Ambiental | GGBIO | Radiation-emitting devices and biosafety |
How decisions are made
ANVISA is governed by a Collegiate Board (Diretoria Colegiada) — five directors appointed by the President of Brazil. Binding RDCs are published in the Diário Oficial da União (DOU). Significant changes must go through a public consultation (audiência pública) before finalisation.