Modernizing Medical Device Regulation: Anvisa’s Collaborative Approach and New Essential Guidelines

Strategic Context of the Update 

The manual’s update is part of a continuous review process for the Manuals of Registration of Health Use Materials and Equipment, with the main objective of aligning this content with the new regulatory framework in the area. This initiative demonstrates Anvisa’s commitment to maintaining an updated and efficient regulatory environment that addresses both public health needs and the demands of the regulated sector. 

Key Regulatory Standards Considered 

The new version of the manual incorporates and aligns with three fundamental Collegiate Board Resolutions (RDC): 

• RDC 751/2022 This resolution establishes the basis for: 

• Risk classification of medical devices. 

• Notification and registration regimes applicable to different product categories. 

• Requirements for labeling and instructions for use of medical devices. RDC 751/2022 represents a significant modernization in the approach to regulating medical devices, establishing clearer criteria aligned with international best practices. 

• RDC 657/2022 Specifically addresses the regularization of Software as a Medical Device (SaMD), an increasingly relevant category in the digital health scenario. This regulation: 

• Defines specific criteria for SaMD classification. 

• Establishes appropriate regulatory requirements for this technology category. 

• Provides clear guidelines on the necessary documentation for regularization. 

• RDC 848/2024 Establishes the essential safety and performance requirements for: 

• Medical devices in general. 

• In vitro diagnostic devices (IVD). This resolution is fundamental to ensure that products marketed in Brazil meet internationally recognized safety and efficacy standards. 

Content and Structure of the Manual 

Strategic Guidance Tool 

The new manual is configured as a strategic guidance tool for the regulated sector, offering detailed guidelines on the entire regularization process. The document’s structure was carefully developed to facilitate the understanding and application of regulatory requirements. 

Key Topics Covered 

1. Company Operating Authorization (AFE) The manual provides comprehensive guidance on: 

1. Requirements for obtaining operating authorization. 

2. Necessary documentation. 

3. Specific procedures for different company profiles. 

4. Maintenance and renewal of the authorization. 

2. Registration and Notification Process Detailed instructions on: 

1. Differentiation between registration and notification regimes. 

2. Specific requirements for each category of medical device. 

3. Necessary technical documentation. 

4. Evaluation and approval timelines. 

3. Correct Sanitary Classification One of the most valuable sections of the manual, presenting: 

1. Clear criteria for product classification. 

2. Decision trees to aid in classification. 

3. Practical examples illustrating the correct application of the criteria. 

4. Common cases that generate doubts in the sector. 

4. Practical Examples and Case Studies The inclusion of practical examples is a key differentiator of the new version, helping: 

1. Manufacturers correctly understand the applicable requirements. 

2. Legal representatives prepare more complete petitions. 

3. Reduction of interpretation errors that could lead to rejections. 

Collaborative Development Process 

Engagement with the Regulated Sector 

One of the highlights of this manual’s update was the collaborative approach adopted by Anvisa. During the document’s elaboration, preliminary versions were shared with representative entities of the sector, including: 

• ABIIS (Brazilian Alliance of the Innovative Health Industry) 

• Abimed (Brazilian Association of the Health Technology Industry) 

• Abimo (Brazilian Association of the Medical Devices Industry) 

• Abraidi (Brazilian Association of Health Product Importers and Distributors) 

This collaborative construction ensured that the manual: 

• Reflects the real needs of the regulated sector. 

• Addresses the main practical difficulties faced by companies. 

• Presents clear and applicable solutions. 

• Is aligned with the business reality of the segment. 

Benefits of the Collaborative Approach 

The engagement of representative entities brought several benefits: 

• Greater practical relevance of the guidance presented. 

• Reduction of interpretive gaps between regulation and market practice. 

• Anticipation of common doubts and clarification within the manual itself. 

• Strengthening the relationship between the regulator and the regulated sector. 

Expected Strategic Impacts 

Improvement in Petition Quality 

One of the main objectives of the new manual is to improve the quality of petitions submitted to Anvisa. This is expected to result in: 

• Reduction of Requirements 

• Fewer requests for additional information. 

• Faster evaluation processes. 

• Less rework for companies. 

• Reduction of costs in the regularization process. 

• Reduction of Rejections 

• Better understanding of applicable requirements. 

• More complete and adequate documentation from the first submission. 

• Fewer technical errors in petitions. 

• Higher process approval rate. 

Operational Efficiency 

The publication of the updated manual contributes to: 

• Streamlining regulatory processes. 

• Reducing the time for petition evaluation. 

• Greater predictability for companies planning product launches. 

• Optimizing resources for both Anvisa and the regulated sector. 

Practical Implications for the Sector 

For Manufacturers 

National and international manufacturers benefit from: 

• Greater clarity on regulatory requirements. 

• Reduction of uncertainties in the development and regularization process. 

• Facilitation of strategic planning for the launch of new products. 

• Alignment with international best practices through modern regulations. 

For Legal Representatives 

Legal representatives and distributors gain: 

• Detailed guidance for correct petition preparation. 

• Practical examples that facilitate the understanding of complex requirements. 

• Reduction of rejection risks due to documentary failures. 

• Greater agility in the regularization process. 

For Consultants and Regulatory Professionals 

Professionals specialized in medical device consulting can: 

• Use the manual as an authoritative reference. 

• Offer more precise and updated guidance to clients. 

• Reduce documentation preparation time. 

• Increase value delivery to clients through superior expertise. 

Integration with the Broader Regulatory Context 

Alignment with International Standards 

The manual’s update also aligns with international trends in the regulation of medical devices, including: 

• Harmonization with standards from the Medical Device Authority of various countries. 

• Consideration of practices from the Health Products Regulatory Authority. 

• Alignment with principles of the Medical Products Agency. 

• Compatibility with international regulatory systems such as MDSAP. 

Continuous Evolution of the Regulatory Framework 

The manual is part of a continuous evolution process of the Brazilian regulatory framework, which includes: 

• Regular updates based on market feedback. 

• Incorporation of new technologies and business models. 

• Adaptation to changes in the global regulatory landscape. 

• Improvement based on implementation experiences. 

Recommendations for the Regulated Sector 

Immediate Actions 

Companies operating in the medical device sector should: 

• Download and study the new manual in detail. 

• Review ongoing processes in light of the new guidelines. 

• Update internal procedures to align with current requirements. 

• Train responsible teams on the new guidelines. 

• Consult specialized professionals when in doubt. 

Strategic Planning 

For the medium and long term, it is recommended to: 

• Establish a process for continuous monitoring of regulatory updates. 

• Invest in training and qualification of regulatory teams. 

• Consider the use of identifier software to facilitate traceability. 

• Implement GMP (Good Manufacturing Practices) internally aligned with Anvisa’s expectations. 

• Maintain open contact with Anvisa for clarifications when necessary. 

For Companies with International Operations 

Companies that also operate in other markets should: 

• Evaluate synergies between Anvisa’s requirements and those of other regulators such as the FDA. 

• Consider the FDA registration process in parallel when applicable. 

• Keep the FDA company registration updated. 

• Use MDSAP certification as a facilitation strategy. 

Additional Resources and Support 

Official Channels 

For additional clarifications and updated information: 

• Anvisa’s official website: www.gov.br/anvisa 

• Anvisa Contact: Through the official channels available on the website. 

• Specific Consultations: Through the formal petitioning system. 

Professional Support 

Companies can seek specialized support through: 

• Medical device consulting specialized in the Brazilian market. 

• Regulatory affairs professionals with experience in medical equipment. 

• Representative entities of the sector (ABIIS, Abimed, Abimo, Abraidi). 

Conclusion 

The publication of the new version of the Manual for Regularization of Medical Equipment and Software as a Medical Device represents a significant advance in the Brazilian regulatory environment. The initiative demonstrates Anvisa’s commitment to: 

• Regulatory transparency. 

• Facilitating access to clear information. 

• Collaboration with the regulated sector. 

• Continuous improvement of regulatory processes. 

For companies operating in the medical device segment, this update represents an opportunity to: 

• Review and improve internal processes. 

• Align operations with regulatory best practices. 

• Reduce risks and costs associated with regularization. 

• Accelerate product time-to-market. 

Success in implementing these new guidelines depends on the active engagement of all actors in the sector – from manufacturers to regulatory professionals, including representative entities and Anvisa itself. 

Source 

• Agência Nacional de Vigilância Sanitária (Anvisa) Official News 

This article was prepared for informational purposes and does not replace consultation with the official legislation in force. For more information on regulatory consulting services and BRH solutions, consult qualified specialists in medical device regulation who maintain up-to-date knowledge of ANVISA requirements and Brazilian medical device regulations. 

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