Regulatory Framework Change: Companies Have Until May 30, 2026 to Transition  Executive Summary  In a significant regulatory development, ANVISA (Brazilian Health Regulatory Agency) has officially approved a new norm regulating the sanitary classification of sodium chloride-based products intended for nasal cavity irrigation as medical devices. This decision, formalized through a decision from Collegiate Board (DICOL) on October 29, 2025, establishes clear guidelines for the transition from medicine to medical device classification, providing legal certainty and regulatory predictability for the sector.  Historical Context and Regulatory Evolution  From Drugs to Medical Devices  The reclassification journey began in 2023 when these products were initially reclassified from medicines to medical devices through ANVISA’s Collegiate Board Decision expressed in Vote No. 128/2023/SEI/DIRE3/ANVISA. However, until now, this change existed only in internal votes and deliberations without a specific normative instrument.  Key Provisions of the New Regulation  1. Explicit Regulatory Classification  The resolution establishes that sodium chloride-based products for nasal irrigation are classified as:  Risk Class IV Medical Devices according to RDC 751/2022 (or subsequent updates)  This classification applies to:  2. Structured Transition Process  The regulation introduces comprehensive rules covering:  Compliance Deadlines  Inventory Depletion Conditions  Clear guidelines for:  Commercialization Criteria  Specific rules governing the sale of products manufactured during the transition period, ensuring market continuity while maintaining safety standards.  Major Innovation: CBPF (GMP) Recognition  Good Manufacturing Practices Certification (CBPF)  One of the most significant advances in the new regulation is the acceptance of CBPF for drugs manufacturers to qualify these products as medical devices. This provision:  ✓ Eliminates a major regulatory barrier reported by manufacturers ✓ Streamlines the compliance process ✓ Reduces duplicative certification requirements  As noted by Director Daniela Marreco, the regulation’s rapporteur: “The Good Manufacturing Practices requirements for both health products and medications are sufficient to ensure the quality and safety of these products.”  This pragmatic approach recognizes that existing quality systems adequately address product safety concerns, facilitating a smoother transition for compliant manufacturers.  Implementation Timeline and Action Plan  Critical Milestones for Companies  Phase  Deadline  Required Actions  Preparation  December 2025  Gap analysis, documentation review, team training  Transition  January-April 2026  Cancel medication notifications, submit medical device registration  Compliance  May 30, 2026  All products must be registered as medical devices  Automatic Cancellation  After May 30, 2026  ANVISA will cancel remaining medication notifications  Recommended Implementation Steps  Phase 1: Assessment (Immediate)  Phase 2: Documentation (November 2025 – January 2026)  Phase 3: Regulatory Submission (February – April 2026)  Phase 4: Market Transition (Through May 2026)  Regulatory Requirements for Medical Device Registration  Classification Under RDC 751/2022  Companies must ensure their products meet Class IV medical device requirements, including:  Essential Documentation  Quality System Requirements  Registration Process  According to RDC 751/2022, Class IV devices require:  Strategic Implications for the Industry  Benefits of the New Framework  1. Regulatory Clarity  2. Operational Efficiency  3. Market Stability  4. Legal Security  Challenges to Address  Companies should proactively manage:  Compliance Checklist for Companies  ☐ Immediate Actions (November 2025)  ☐ Short-Term Actions (December 2025 – February 2026)  ☐ Medium-Term Actions (March – May 2026)  ☐ Ongoing Compliance (Post-May 2026)  Expert Consulting Support  Navigating this significant regulatory transition requires specialized expertise in both medicines regulations and medical device regulatory affairs. Professional consulting can provide:  Gap Analysis Services  Registration Support  Quality System Implementation  Strategic Planning  Additional Resources and References  Primary Regulatory Framework  ANVISA Resources  Conclusion  The formal approval of this new regulation represents a milestone in Brazilian regulatory evolution, bringing alignment with international best practices and providing the necessary legal framework for the saline solutions market. The acceptance of medication CBPF for medical device qualification demonstrates ANVISA’s pragmatic approach to regulatory efficiency without compromising safety standards.  Key Takeaways:  Organizations should begin implementation activities immediately to ensure smooth transition and avoid automatic cancellation of medication notifications. Engaging with medical device consulting specialists and staying informed through official ANVISA communications will be critical for success.  For specialized support in medical device registration, quality system implementation, and regulatory compliance with RDC 751/2022 and MDSAP requirements, contact regulatory affairs experts with proven experience in ANVISA procedures and international standards.  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

Brazil is consolidating its position as one of the most promising markets for international medical device manufacturers. With an increasingly mature regulatory environment, growing demand for cutting-edge technologies, and hospitals undergoing full modernization, the country has become a strategic destination for companies looking to expand their global presence.  And with MEDICA 2025 (November 17–20) approaching, this is the ideal time to plan your entry in a structured and secure way.  Why Brazil is a Strategic Opportunity  This combination reveals a clear scenario: there is space and demand for innovative solutions. The challenge, however, lies in efficiently navigating the country’s regulatory and commercial environment.  Essential Requirements for Medical Device Entry into Brazil  Entering the Brazilian market requires more than just a good product. It is necessary to comply with specific technical, legal, and regulatory requirements, supervised by ANVISA (National Health Surveillance Agency).  Key focus areas include:  Brisa Advisors’ Solution: A Complete Ecosystem for International Manufacturers  At Grupo Brisa Advisors, we offer an end-to-end approach for companies that want to access the Brazilian market in a structured and efficient way. Our ecosystem integrates regulatory consulting, legal support, distribution, and connection with buyers—all in a single entry flow.  With this structure, we help our clients reduce time-to-market, minimize risks, and achieve sustainable results.  Why Choose Brisa Advisors  Invitation to MEDICA 2025  Brisa Advisors will be present at MEDICA 2025, in Düsseldorf, from November 17 to 20.  Our schedule is open for in-person meetings, as well as pre-event appointments, where we will present our ecosystem and a customized proposal for entering the Brazilian market.  📅  Schedule your in-person meeting: https://calendly.com/brisa-advisors/30min  Brisa Advisors – Connecting Global Innovation to the Brazilian Market  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

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):  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  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:  This collaborative construction ensured that the manual:  Benefits of the Collaborative Approach  The engagement of representative entities brought several benefits:  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:  Operational Efficiency  The publication of the updated manual contributes to:  Practical Implications for the Sector  For Manufacturers  National and international manufacturers benefit from:  For Legal Representatives  Legal representatives and distributors gain:  For Consultants and Regulatory Professionals  Professionals specialized in medical device consulting can:  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:  Continuous Evolution of the Regulatory Framework  The manual is part of a continuous evolution process of the Brazilian regulatory framework, which includes:  Recommendations for the Regulated Sector  Immediate Actions  Companies operating in the medical device sector should:  Strategic Planning  For the medium and long term, it is recommended to:  For Companies with International Operations  Companies that also operate in other markets should:  Additional Resources and Support  Official Channels  For additional clarifications and updated information:  Professional Support  Companies can seek specialized support through:  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:  For companies operating in the medical device segment, this update represents an opportunity to:  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  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.  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

The medical device industry is undergoing an accelerated transformation. Technologies that seemed distant just a few years ago are now being implemented in healthcare systems around the world.  At MEDICA 2025, taking place in Düsseldorf, these innovations will be in absolute spotlight.  Based on analysis of global regulatory trends (FDA, MDR, and Anvisa) and international market movements, we’ve identified the main technological trends that will dominate the event and shape the future of the sector.  If your company develops, manufactures, or distributes medical devices, this article is essential to understand where the market is evolving, how to prepare regulatorily, and which opportunities deserve attention.  1. Artificial Intelligence and Machine Learning  AI has consolidated itself as a reality in medical devices, moving from experimental to an established clinical tool.  Featured applications:  2. SaMD (Software as Medical Device)  SaMD is recognized as the fastest-growing segment in the medical device market.  Expanding categories:  3. Telemedicine and IoMT (Internet of Medical Things)  The convergence of SaMD, wearables, and connectivity creates the IoMT ecosystem.  Featured devices:  4. Sustainability and ESG  Sustainability has shifted from optional to regulatory requirement.  Trends:  5. Laboratory Developed Tests (LDTs) and Molecular Diagnostics  LDTs are tests developed and validated by specific laboratories, growing in importance through diagnostic personalization.  Applications:  6. 3D Printing and Personalized Manufacturing  3D printing has matured for real clinical production of personalized devices.  Applications:  7. Surgical Robotics and Automation  Robotics is becoming democratized with smaller, more accessible systems.  Evolution:  Opportunities in the Brazilian Market  Brazil is a strategic market for adopting new medical technologies with unique characteristics that favor the implementation of innovations.  Why Brazil is Relevant for Emerging Technologies  How We Can Support Your Entry into Brazil  The trends presented are not a distant future—they are happening now.  Winning companies:  Meet Us at MEDICA 2025  We will be in Düsseldorf to:  Schedule Your Meeting  Schedule now: https://calendly.com/brisa-advisors/30min  The future of medicine is being built now. We are here to ensure your company is among the leaders.  See you at MEDICA 2025!  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

Measure Simplifies the Process for Good Manufacturing Practices Certification  Regulatory Streamlining in Medical Device Manufacturing Certification  The Brazilian National Health Surveillance Agency (Anvisa) has unified the subject codes used when petitioning for the Good Manufacturing Practices Certificate (CBPF – Certificado de Boas Práticas de Fabricação) for medical devices. This regulatory initiative aims to simplify the regulatory process, reduce bureaucracy, and align procedures with current legislation.  Key Changes in the Regulatory Framework for Medical Devices  With the new measure, all medical devices—including in vitro diagnostic products—will be handled under the same petition subjects, reflecting the approach already adopted by Collegiate Board Resolution (RDC) 751/2022, which establishes a unified structure for GMP requirements.  The unification of petition subjects also encompasses medical products and in vitro diagnostic products, regardless of their industrial origin (national, international, or Mercosur), and within the context of the Medical Device Single Audit Program (MDSAP). The change represents a significant step forward in debureaucratization for the sector, promoting greater efficiency in certification processes and alignment with international practices.  Impact on Pending Processes  Anvisa informs that there will be no impact on CBPF processes already filed or under analysis, even if they were submitted under previous petition subjects.  Furthermore, during the renewal process for CBPFs for manufacturing units that produce both medical products and in vitro diagnostic products, it will be possible to opt to renew only one of the processes, preferably the one with the closest expiration date, provided that the information for all involved medical devices is consolidated in the petition form.  Alignment with International Standards  This unification effort demonstrates Anvisa’s commitment to harmonizing Brazilian regulations with global standards, particularly in relation to:  Benefits for Medical Device Companies  The consolidation of petition subject codes offers several advantages for companies operating in the medical device sector:  Accessing the New Petition Subjects  Companies can consult the new petition subjects through the official Anvisa portal at: https://consultas.anvisa.gov.br/#/consultadeassuntos/  For organizations seeking medical device consulting support or guidance on FDA registration and international compliance, understanding these changes is crucial for maintaining regulatory compliance in Brazil and abroad.  Implications for Medical Device Regulatory Strategy  This regulatory update reinforces the importance of maintaining robust quality management systems and staying current with evolving regulatory requirements. Companies that manufacture medical devices, whether for the domestic market or export, should review their certification strategies to take advantage of these simplified procedures.  Organizations involved with laboratory-developed tests, software as a medical device (SaMD), or other innovative medical technologies should pay special attention to how these changes affect their certification timelines and requirements.  Official Source: Anvisa – Unification of Petition Subject Codes for CBPF  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

We are confirmed to participate in MEDICA 2025 with a clear objective: to connect international medical device manufacturers to the Brazilian market through our specialized medical device consulting and Brazilian hosting service.  Schedule Your Meeting with Us  In the meeting, we will discuss:  Exclusive bonus for those who schedule at MEDICA:  Why Choose Us? Differentiators That Make a Difference  1. Proven Regulatory Expertise  We are not a generalist consultancy, which means:  Our team is composed of:  2. Complete and Transparent Process  Our process was developed to ensure efficiency, predictability, and full compliance:  3. Deep Knowledge of RDC 751/2022  RDC 751/2022 establishes the Good Manufacturing Practices (GMP) requirements for health products in Brazil. Many international companies face difficulties in adapting their processes to this regulation.  4. Complementary Services for Market Entry  In addition to Anvisa registration, we offer complete support for establishment in Brazil:  Wherever you are in the world, we are ready to bring your products to the Brazilian market with safety, agility, and total compliance. See you at MEDICA 2025!  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

Unparalleled Global Scale and Relevance  MEDICA isn’t just a trade show—it’s the world’s largest global marketplace for medical technology, uniting the entire healthcare value chain in one location. The numbers are impressive:  Global Participation:  International Reach  Comprehensive Technological Scope  MEDICA covers all segments of the medical device market, offering a 360° view of the sector:  5 Definitive Reasons Your Company Can’t Afford to Miss MEDICA 2025  1. Expansion into International Markets and Strategic Networking  Direct Access to Global Buyers  MEDICA brings together the world’s leading buyers and decision-makers. In four days, you can:  For Brazilian companies, MEDICA is the most efficient gateway to:  High-Level Networking  Unlike regional trade fairs, MEDICA exclusively attracts qualified professionals:  Practical result: A 30-minute meeting at MEDICA can generate opportunities that would take months to establish through other means.  2. Competitive Intelligence and Global Trend Analysis  Complete Market View in One Place  MEDICA offers a unique opportunity for competitive benchmarking:  Competitive Analysis:  Market Gap Identification:  Technological Trends for 2025–2026  Based on previous editions and confirmations for 2025, the main themes will be:  Artificial Intelligence and Machine Learning:  Software as a Medical Device (SaMD):  Sustainability and ESG:  Wearables and IoMT (Internet of Medical Things):  3D Printing and Personalization:  3. Specialized Workshops and Conferences  MEDICA offers more than 300 parallel events, including:  Benefit for your company: Regulatory updates that would cost thousands of dollars in specialized consulting, available for free during the event.  4. Global Partnership and Distribution Opportunities  Find the Ideal Partner for Every Market  MEDICA facilitates strategic connections that drive growth:  For Manufacturers:  For Distributors:  For Service Providers:  Technological Partnerships  MEDICA is also a hub for collaborative innovation:  Conclusion: The Smartest Investment for 2025  MEDICA isn’t just a trade fair—it’s the single most important strategic investment your company can make to grow in the global medical device market.  Recapping the 5 Reasons to Attend:  MEDICA 2025 promises to be the largest and most innovative edition in history, with a special focus on:  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br