RDC
Resolução da Diretoria Colegiada
A Collegiate Board Resolution is ANVISA’s primary binding regulation. The number is sequential within the year (RDC 751/2022 is resolution 751 issued in 2022).
Brazil medical device regulations
Official sources linkedANVISA rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
16 documents7 categories100% linked to official sourcesauthority ANVISA16 readable HTML
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| RDC 925/2024 | Personalized Medical Devices Requirements for manufacture, commercialization, import, and use of personalized medical devices, including patient-matched and custom-made devices. | Registration | September 24, 2024 | Official |
| RDC 848/2024 | Essential Safety and Performance Requirements Essential safety and performance requirements for medical devices and in vitro diagnostic medical devices (IVDs). Replaces the previous essential requirements framework used with RDC 751/2022. | Registration | September 4, 2024 | Official |
| RDC 884/2024 | UDI Implementation Timeline Extension Amends RDC 591/2021, extending UDI implementation deadlines. Rectified in the Official Gazette on July 2, 2024. | UDI | July 1, 2024 | Official |
| IN 290/2024 | Leveraging Foreign Regulatory Authorizations (AREE) Establishes an optimized analysis procedure for Class III/IV marketing authorization petitions by using assessments from Equivalent Foreign Regulatory Authorities (AREE/EFRA), including FDA, Health Canada, Japan, and Australia TGA. | Registration | June 3, 2024 | Official |
| RDC 830/2023 | In Vitro Diagnostic (IVD) Medical Devices Regulation for IVD medical devices including classification (Class I-IV), registration pathways, self-testing requirements, and companion diagnostics. Replaced RDC 36/2015. | Registration | June 1, 2024 | Official |
| RDC 850/2024 | GMP Certificate Extension for MDSAP Manufacturers Amends Article 8 of RDC 497/2021 so qualifying Good Manufacturing Practices certificates granted through MDSAP are valid for four years, subject to continued participation in MDSAP. | GMP/QMS | April 1, 2024 | Official |
| RDC 837/2023 | Clinical Investigations with Medical Devices Procedures and Good Clinical Practice requirements for clinical investigations with medical devices in Brazil whose results may support Class III and IV registration. | Clinical Trials | December 15, 2023 | Official |
| RDC 751/2022 | Medical Device Registration and Classification Core regulation for medical device classification (Class I-IV) and registration pathways (notification vs. marketing authorization) in Brazil. | Classification | March 1, 2023 | Official |
| RDC 657/2022 | Software as Medical Device (SaMD) Requirements for regularizing Software as a Medical Device (SaMD), including classification, technical documentation, software validation, cybersecurity, labeling, and post-market responsibilities. | Software/SaMD | July 1, 2022 | Official |
| RDC 687/2022 | GMP Inspection and Certification Programs for Medical Devices Inspection programs and criteria for granting or renewing Good Manufacturing Practices certificates for medical device manufacturers, including use of MDSAP audit reports and regulatory-authority inspection information. | GMP/QMS | June 1, 2022 | Official |
| RDC 665/2022 | Good Manufacturing Practice (GMP) for Medical Devices GMP requirements for medical device manufacturers including quality management system, design controls, and production processes. Replaced RDC 16/2013. | GMP/QMS | May 2, 2022 | Official |
| RDC 591/2021 | Unique Device Identification (UDI) System Brazil's UDI system requiring unique identifiers, machine-readable and human-readable labeling, and submission to ANVISA's UDI database. Implementation deadlines were later amended by RDC 884/2024. | UDI | January 10, 2022 | Official |
| RDC 551/2021 | Field Safety Corrective Actions Notification Requires registration holders to execute and notify field safety corrective actions, including recalls, corrections, and safety communications to ANVISA and healthcare facilities. | Vigilance | October 1, 2021 | Official |
| RDC 497/2021 | GMP and Distribution/Storage Certification Procedures Administrative procedures for granting Good Manufacturing Practices certificates and Good Distribution and/or Storage Practices certificates. Article 8 amended by RDC 850/2024 to extend MDSAP-linked certificates from 2 to 4 years. | GMP/QMS | June 1, 2021 | Official |
| RDC 40/2015 | Notification Process for Class I and II Medical Devices Simplified notification process for Class I and II medical devices. Revoked by RDC 751/2022. | Registration | October 26, 2015 | Official |
| RDC 67/2009 | Technovigilance Rules for Medical Devices Establishes technovigilance rules for medical device registration holders in Brazil. Defines adverse event reporting requirements, timelines, and post-market surveillance procedures. | Vigilance | December 23, 2009 | Official |
Exports carry source + retrieval dateRegulation codes
What these codes are
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
IN
Instrução Normativa
A Normative Instruction details how an RDC is applied — procedures, timelines, or documentary requirements. It does not replace the parent RDC.
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Tracked from official ANVISA publications · row IDs are stable — cite as regulations:brazil:in-290-2024