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 processes, 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.

What are the key requirements of RDC 751/2022?

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 on their respective health impacts, which allows appropriate regulatory oversight of product modifications.

• Additional technical approvals: Certain medical devices require INMETRO conformity certification. Devices with Bluetooth, Wi-Fi, cellular, or other regulated radio functions may also require ANATEL certification and homologation. INMETRO and ANATEL are adjacent technical authorities; ANVISA remains the medical device regulator.

• 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.

Does RDC 751/2022 cover in vitro diagnostic devices?

No. RDC 751/2022 addresses general medical devices. IVD notification, registration, classification and labeling are governed principally by RDC 830/2023. A product's intended purpose should be resolved before selecting the framework because a general device and an IVD can follow different evidence and classification rules.

When can INMETRO or ANATEL requirements also apply?

Some devices need INMETRO certification for regulated safety or performance characteristics, and devices using regulated radio technologies can need ANATEL approval. These technical approvals do not replace ANVISA market authorization. They should be planned as coordinated workstreams within the Brazil registration pathway.