RDC 830/2023

Resolution (RDC) 830/2023 is the regulation governing in vitro diagnostic (IVD) medical devices in Brazil. ANVISA (Brazilian Health Regulatory Agency) published it in the Federal Official Gazette on 11 December 2023 and established the rules for risk classification, notification and registration requirements, labeling, and Instructions for Use (IFU) for IVDs. The resolution entered into force on 1 June 2024.

RDC 830/2023 defines IVDs as reagents, calibrators, standards, controls, sample collectors, software, instruments, or other products used individually or in combination for in vitro analysis of samples from the human body to provide information for diagnosis, monitoring, compatibility, screening, prognosis, or determination of physiological status.  

Key features of RDC 830/2023 include:

• Dual risk assessment framework: Classification considers both risk to the individual (low, medium, high) and risk to public health (low, medium, high), with Class I representing low risk to both and Class IV representing high risk to both. The regulation provides eight detailed classification rules covering blood screening, immunology testing, infectious disease detection, genetic testing, companion diagnostics, self-testing devices, and general laboratory products.

• Risk-based 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. The regulation establishes specific technical dossier requirements for each risk class. Class III and IV devices require comprehensive clinical performance data.

• Self-testing device restrictions: Certain high-risk tests cannot be supplied to lay users, including those for communicable diseases subject to mandatory notification, blood typing, genetic testing, serious disease diagnosis, and drug detection. Self-testing devices are generally classified as Class III, with some exceptions.

• Technical dossier structure: Registration applicants must submit comprehensive documentation including product description, risk management, performance studies (analytical sensitivity, specificity, precision, accuracy), stability data, clinical performance evidence, and manufacturing information. The dossier structure aligns with International Medical Device Regulators Forum (IMDRF) standards.

• Performance and clinical evidence requirements: Class II devices require performance studies, including analytical characterization. Class III and IV devices also require clinical performance data, including clinical sensitivity and specificity, expected/reference values, and clinical evidence assessment reports that may include product-specific clinical studies.

• Good Manufacturing Practices (GMP): Registration for Class III and IV IVDs requires valid GMP certification issued by ANVISA.

• Labeling and Instructions for Use (IFU): Labeling must be in Portuguese for both primary and secondary labeling. IFU must be comprehensive for professional users and simplified for lay users, with restrictions on digital IFU for self-testing products, point-of-care devices, and lay user instruments.

• Change system: There are three types of modifications: changes that require approval (high health relevance), immediate implementation (medium relevance), or non-reportable (minor relevance). Class I and II alterations are generally processed through immediate implementation.

• Medical Devices Documentary Repository: IFU must be uploaded to ANVISA's digital repository within 30 days of publication for new products and alterations, or 180 days for non-reportable changes affecting instructions.

IVDs manufactured in Brazil exclusively for export do not require ANVISA notification or registration. RDC 830/2023 does not cover medical devices, which are addressed by RDC 751/2022.

Read RDC 830/2023.

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