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
Regulatory package: RDC 751/2022 was issued on 26 May 2022 together with four companion RDCs forming a comprehensive modernised regulatory framework:
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RDC 752/2022 — GMP (CBPF)
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RDC 753/2022 — Adverse event reporting and recalls
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RDC 754/2022 — Labelling
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RDC 755/2022 — Establishment authorisation (AFE)
Verify all information against official ANVISA sources before making regulatory decisions.
Essential Requirements in RDC 751/2022 Annex II are aligned with IMDRF guidance and established international standards (ISO 13485, ISO 14971, IEC 60601 series, ISO 10993, IEC 62304, and IEC 62366). Manufacturers may demonstrate compliance with Essential Requirements through: (1) recognised ABNT standards (which adapt ISO/IEC equivalents); (2) equivalent ISO/IEC standards directly; or (3) device-specific technical justification approved by ANVISA. The most common pathway for international manufacturers is use of ABNT equivalents or ISO/IEC standards listed in the ANVISA harmonised standards catalogue.