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January 15, 2026
Approximately 5 minutes
Brazil ANVISA RDC 751/2022: Medical Device Risk Classification Rules and Regulatory Requirements
Brazil ANVISA RDC 751/2022: Medical Device Risk Classification Rules and Regulatory Requirements
1. Overview and Scope
Resolution of the Collegiate Board of Directors (RDC) No. 751/2022, effective March 1, 2023, provides the core regulatory framework for medical devices in Brazil, covering risk classification, labeling, instructions for use, notification, marketing authorization (registration), alterations, revalidation, and cancellation. It applies to devices requiring notification or authorization based on risk class, including accessories. Exclusions include IVDs (separate regulation), used/reconditioned devices, custom-made devices, and certain combined products. Source: ANVISA RDC No. 751/2022 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-751-2022-en.pdf)
2. Risk Classification (Classes I-IV)
Devices are classified into four risk classes:
- Class I: Low risk
- Class II: Medium risk
- Class III: High risk
- Class IV: Maximum risk
Classification is based on intended purpose and 22 rules in Annex I, considering duration of use (transient <60 min, short-term 60 min-30 days, long-term >30 days). The most stringent applicable rule prevails. Software as a medical device (SaMD) is classified independently if standalone. Source: ANVISA RDC No. 751/2022 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-751-2022-en.pdf)
Key rules include:
- Non-invasive devices (Rules 1-4): Generally Class I unless modified fluids or in contact with injured skin.
- Invasive devices (Rules 5-8): Higher classes for surgical, implantable, or long-term use.
- Active devices (Rules 9-13): Class II/III for therapeutic/diagnostic energy delivery or control.
- Special rules (14-22): Class III/IV for substances, contraception, disinfection of invasives, nanomaterials, etc.
In case of doubt, ANVISA determines the class. Source: ANVISA RDC No. 751/2022 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-751-2022-en.pdf)
3. Notification and Marketing Authorization (Registration)
- Classes I and II: Notification regime with simplified documentation. Indefinite validity.
- Classes III and IV: Full marketing authorization with technical dossier review, valid for 10 years (renewable).
Required elements include fees, forms, manufacturer authorization (for imports), GMP certificate (III/IV), SBAC conformity (electromedical), and compliance declarations. Source: ANVISA RDC No. 751/2022 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-751-2022-en.pdf)
4. Alterations, Revalidation, and Cancellation
Alterations are categorized as:
- Approval-required (high impact, prior ANVISA approval)
- Immediate implementation (medium, post-implementation submission)
- Non-reportable (low, internal record only)
Revalidation required for III/IV every 10 years with updated GMP. Cancellation possible for non-compliance, false information, or safety risks. Source: ANVISA RDC No. 751/2022 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-751-2022-en.pdf)
5. Labeling and Instructions for Use
Must be in Portuguese, include ANVISA registration number, manufacturer/holder details, traceability (batch/serial), warnings, and symbols per standards. Instructions for use mandatory except for low-risk devices where safe without. Electronic instructions allowed under conditions. Source: ANVISA RDC No. 751/2022 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-751-2022-en.pdf)
6. Technical Dossier
Maintained by the holder (not submitted routinely but available for inspection). Structured per Annex II, with increasing detail by class: description, safety/performance studies, manufacturing, labeling, etc. Critical for III/IV authorization. Source: ANVISA RDC No. 751/2022 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-751-2022-en.pdf)
7. Transitional and Final Provisions
Devices under old framework remain valid until alterations or revalidation. 365-day period post-March 2023 for reclassification shifts (e.g., notification to authorization requires full submission and GMP). Revokes prior resolutions. Source: ANVISA RDC No. 751/2022 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-751-2022-en.pdf)
8. Practical Considerations for RA Managers
Accurate classification is foundational—document intended purpose rigorously. Prepare for GMP and SBAC where applicable. Track alterations to avoid suspensions. Transitional reclassifications require urgent action to prevent cancellation. Source: ANVISA RDC No. 751/2022 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-751-2022-en.pdf)
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