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January 20, 2026
Approximately 5 minutes
Brazil ANVISA RDC 848/2024: Essential Safety and Performance Requirements for Medical Devices and IVDs
Brazil ANVISA RDC 848/2024: Essential Safety and Performance Requirements for Medical Devices and IVDs
1. Overview and Scope
Collegiate Board Resolution - RDC No. 848, dated March 6, 2024 (published March 8, 2024), establishes the essential principles of safety and performance applicable to all medical devices and in vitro diagnostic (IVD) medical devices in Brazil. It replaces RDC No. 546/2021 and came into force 180 days after publication (September 2024). The resolution aims to ensure devices are designed and manufactured to achieve intended performance while maintaining an acceptable risk-benefit ratio, considering the state of the art. Some principles may not apply to specific devices, with justifications required. Compliance is verified through technical dossiers, GMP inspections, and regularization processes. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
2. General Safety and Performance Requirements
Devices must:
- Achieve manufacturer-intended performance and be suitable for the declared purpose under normal conditions.
- Be safe, with risks acceptable compared to patient benefits, not compromising health/safety of patients, users, or others.
- Maintain characteristics/performance during shelf life, transport, storage, and use.
Risks must be reduced as far as possible without adversely affecting the benefit-risk ratio, considering state-of-the-art technology. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
3. Risk Management Throughout Lifecycle
Manufacturers must establish, implement, document, and maintain a systematic risk management system covering the entire lifecycle, including:
- Risk management plan.
- Hazard identification, risk estimation/evaluation (including foreseeable misuse).
- Risk control measures (prioritize safe design, protective measures, then user information).
- Post-production information review and system updates.
Residual risks must be disclosed where relevant. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
4. Clinical Evaluation and Data
Clinical data must support safety, performance, and benefit-risk via ongoing clinical evaluation:
- Literature analysis or clinical investigations (per good clinical practices if needed).
- Updated throughout lifecycle.
- Mandatory investigations where literature insufficient for high-risk or novel devices.
Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
5. Chemical, Physical, and Biological Properties
Devices must be biocompatible, non-toxic, and minimize risks from substances, contaminants, leaching, particles (including nanomaterials), and infection transmission. Animal-derived materials require controlled sources and inactivation processes. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
6. Infection and Microbial Contamination
Sterile devices must use validated sterilization methods with suitable packaging. Reprocessable devices must allow effective cleaning/sterilization. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
7. Devices with Software and Cybersecurity
Software-incorporating devices (including SaMD) must ensure accuracy, reliability, and cybersecurity throughout lifecycle, with validated development processes and specified IT requirements. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
8. Active Devices and Energy Delivery
Reduce risks from electrical/mechanical/thermal hazards, electromagnetic interference, and single-fault conditions. Provide alarms/indicators for critical parameters. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
9. Radiation Protection
Minimize exposure while achieving diagnostic/therapeutic purpose. Provide dose information, controls, and warnings. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
10. Devices for Lay Use and Specific Categories
Lay-user devices must minimize error risks and provide clear instructions/verification means. Additional rules for implants, substance-administering devices, and those incorporating medicines. For IVDs: analytical and clinical performance, traceability, and population-specific evaluation. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
11. Labeling and Instructions for Use
Information must be clear, understandable, and include identification, warnings, performance data, and residual risks. Electronic instructions allowed under conditions. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
12. Conformity Assessment and Documentation
Demonstrated via technical dossier maintained by manufacturer, verified during regularization (notification/registration) and inspections. Aligns with broader framework (e.g., RDC 751/2022 for classification, RDC 549/2021 for electromedical SBAC certification). Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
13. Transitional Provisions
Protocols submitted before effectiveness may use prior requirements (RDC 546/2021). Full application mandatory for new submissions post-September 2024. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
14. Practical Considerations for RA Managers
Update technical dossiers to address new emphases (cybersecurity, lifecycle risk management, clinical data). Justify non-applicable principles. Coordinate with certification bodies for electromedical (SBAC/INMETRO). Review legacy devices for compliance gaps during revalidation. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
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