Medical devices play a crucial role in the diagnosis, prevention, monitoring, and treatment of diseases. To ensure that these products maintain their safety, efficacy, and quality over time, ANVISA (Brazilian Health Regulatory Agency) in Brazil implements periodic reassessment processes.
What is the Reassessment of Medical Devices?
The reassessment of medical devices is a regulatory process that analyzes already registered products to verify if they continue to meet safety and efficacy requirements according to the latest scientific and technological advancements. This process is fundamental for the protection of public health and to ensure that medical devices available on the Brazilian market remain suitable for use.
Legal Basis in Brazil
In Brazil, the reassessment of medical devices is mainly regulated by RDC 751/2022, which establishes the procedures for registration, modification, revalidation, and cancellation of the registration of medical products. This resolution replaced previous regulations and brought important updates to align Brazil with international best practices in medical device regulation.
RDC 848/2024 also addresses aspects related to the safety and continuous monitoring of devices, being crucial for the reassessment process.
Technical Triggers for Reassessment
The reassessment of a medical device can be initiated for different reasons:
- Five-year registration renewalÂ
- Technovigilance notificationsÂ
- Emerging scientific evidenceÂ
- Updates in technical standardsÂ
- ANVISA’s determination based on post-market surveillance dataÂ
Technical Process of Reassessment
Critical Technical Aspects
Quality Systems
Compliance with Good Manufacturing Practices is verified during the reassessment, focusing on:
- Statistical process controlÂ
- Corrective and preventive action systemÂ
- Supplier managementÂ
- Validation of production processesÂ
Software as a Medical Device (SaMD)
For SaMDs, the reassessment incorporates verification of:
- Software development lifecycle (IEC 62304)Â
- Specific risk management (ISO 14971)Â
- Cybersecurity (IEC 81001-5-1)Â
- Validation of algorithms and interoperabilityÂ
Harmonization with International Parameters
The process aligns with the practices of international agencies, adopting:
- IMDRF format for technical documentationÂ
- Harmonized device classificationÂ
- Standardized clinical evaluation criteriaÂ
Technical Strategies for Compliance
For efficiency in the reassessment process, the following is recommended:
- Implementation of a technovigilance system with advanced statistical analysisÂ
- Systematic monitoring of regulatory updatesÂ
- Structured technical documentation according to the IMDRF formatÂ
- Continuous validation of critical processesÂ
- Maintenance of an updated technical dossierÂ
Technical-Regulatory Implications
The reassessment ensures:
- Continuous compliance with updated technical parametersÂ
- Maintenance of the sanitary registration validityÂ
- Risk mitigation through systematic analysisÂ
- Updating of technical specifications according to scientific advancementsÂ
Conclusion
The medical device reassessment process is an essential tool to guarantee the safety, efficacy, and quality of products used in the Brazilian healthcare system. Although it represents a challenge for companies, the reassessment significantly contributes to the protection of public health and the strengthening of the national regulatory system.
For international companies that wish to keep their products on the Brazilian market, a thorough understanding of the reassessment process and preparedness to meet ANVISA’s requirements are fundamental for long-term success.
For more information about the medical device reassessment process, please contact our specialized team, which can offer personalized support for each product category.
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