RDC 751/2022 — Core Medical Device Registration Regulation

RDC 751/2022 (Resolução da Diretoria Colegiada) is the primary regulation for medical device registration in Brazil. It replaced the former RDC 185/2001 and fundamentally modernised Brazil's medical device regulatory framework, aligning it more closely with international standards (IMDRF, EU MDR, ISO).

Key provisions

Topic	Key content
Scope	Defines which products are medical devices and subject to this regulation
Classification	Four risk classes (I–IV); rules in Annex I
Registration pathways	Notificação, Cadastro, Registro — by class
Technical dossier	Essential Requirements (Annex II) and documentation requirements
Clinical evidence	Requirements for clinical evaluation data by class
Registration holder	Duties of the registration holder (manufacturer or importer)
Post-market	PMS plan requirements; link to RDC 753/2022 for adverse events
Changes	Post-registration change management (Petição de Alteração)
Renewal	10-year registration validity; renewal process

The RDC 751/2022 package

RDC 751/2022 was issued together with four companion RDCs forming a comprehensive regulatory framework:

• RDC 752/2022 — GMP (CBPF)

• RDC 753/2022 — Adverse event reporting and recalls

• RDC 754/2022 — Labelling

• RDC 755/2022 — Establishment authorisation (AFE)

• RDC 751/2022 — DOU

---

Official sources

Verify all information against official ANVISA sources before making regulatory decisions.