RDC 751/2022

Resolution (RDC) 751/2022 is the comprehensive regulation governing medical devices in Brazil. It was enacted by ANVISA (Brazilian Health Regulatory Agency) and establishes the rules for risk classification, notification and registration pocesses, labeling requirements, and Instructions for Use (IFU).. The resolution entered into force on 1 March 2023.

RDC 751/2022 defines medical devices to include instruments, apparatus, equipment, implants, software, materials, and other articles intended for specific medical purposes whose main action is not achieved through pharmacological, immunological, or metabolic means.  

Key features of RDC 751/2022 include:

• Classification: The regulation applies a risk-based device classification system that categorizes medical devices into four classes (I through IV), ranging from low risk to maximum risk. It provides 22 detailed classification rules covering non-invasive, invasive, surgically invasive, active, and special category devices.

• Regulatory pathways: Class I and II devices (low to medium risk) require notification, while Class III and IV devices (high to maximum risk) require registration.  

• Technical dossier requirements: Registration applicants must submit comprehensive technical documentation demonstrating safety and performance, including risk management, essential safety requirements, biocompatibility assessments, and clinical evidence when applicable.

• Good Manufacturing Practices (GMP): Registration for class III and IV devices requires valid GMP certification issued by ANVISA, with ongoing maintenance requirements.  

• Labeling and Instructions for Use (IFU): Mandatory information requirements in Portuguese, with provisions for digital formats for certain products. IFU must be uploaded to ANVISA's Documentary Repository of Medical Devices within specified timeframes.

• Change management: There are three categories of changes—required approval, immediate implementation, and non-reportable—based their respective health impacts, which allows appropriate regulatory oversight of product modifications.

• Brazilian Conformity Assessment System (SBAC): Certain medical devices require compliance certification by INMETRO and ANATEL, Brazil's accreditation body that oversees technical and quality compliance for certain products, to ensure conformity with applicable technical regulations and standards.

• Special provisions: The regulation addresses device families, systems, and kits; accessories; Software as a Medical Device (SaMD); devices containing nanomaterials; and devices incorporating substances of biological origin.

RDC 751/2022 does not include IVDs in its scope. IVDs are covered by RDC 830/2023.

Read RDC 751/2022 here.

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