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 

Introduction The Brazilian medical device market represents one of the most complex and dynamic regulatory environments in Latin America. With ANVISA establishing stringent requirements and constantly evolving regulations, selecting the right medical device consulting partner has become crucial for companies seeking to establish or expand their presence in this market. The Current Regulatory Landscape Brazil’s regulatory framework for medical devices has undergone significant transformation, particularly with the implementation of RDC 751/2022 and RDC 830/2023, which replaced previous regulations and aligned Brazilian requirements more closely with international standards. Understanding regulations such as RDC 665/2022 and navigating the complex web of RDCs requires specialized expertise that only experienced consultants can provide. Integration with international programs like MDSAP (Medical Device Single Audit Program) adds another layer of complexity, requiring consultants to have comprehensive knowledge of both local Brazilian requirements and global harmonization initiatives. Technical Criteria for Selecting a Regulatory Consultancy 1. Deep Knowledge of ANVISA Requirements A competent medical device consulting firm should demonstrate: 2. Alignment with International Standards Consultants should possess: 3. Specialized Industry Experience Look for consultants with a proven track record in: Behavioral and Partnership Criteria 1. Transparency and Communication An effective medical device consultancy requires: 2. Partnership Approach The ideal consultant should act as an extension of your team: The Critical Importance of BRH Solutions One of the most crucial factors in selecting a regulatory consultancy is its ability to provide Brazilian Registration Holder (BRH) solutions. This requirement, fundamental to Brazilian medical device regulations, necessitates that consultancies offer: Why BRH Integration Matters What to Look for in BRH Services Evaluating Team Competence Technical Expertise Assessment When evaluating a medical device consulting team, consider: Track Record Verification Request and verify: Technology and Process Integration Digital Infrastructure Modern regulatory consultancies should leverage: Cost-Benefit Analysis Understanding True Value The cheapest consulting option is rarely the most economical. Consider: Investment Protection Quality consulting protects your investment through: Red Flags to Avoid Warning Signs Be cautious with consultants who: Preparing Your Regulatory Strategy for the Future Anticipating Regulatory Evolution The best medical device consulting partners help you prepare for: Strategic Planning Work with consultants who can: Conclusion Choosing the right medical device consulting partner is a strategic decision that can significantly impact your success in the Brazilian market. The ideal consultant combines deep technical expertise in ANVISA requirements, comprehensive understanding of regulations such as RDC 751/2022, and practical experience with programs like MDSAP. Beyond technical competence, successful partnerships require transparency, strong communication, and a genuine commitment to long-term success. The ability to provide integrated BRH solutions is particularly critical, optimizing operations and ensuring comprehensive regulatory compliance. By carefully evaluating potential consultants against these criteria—technical expertise, behavioral fit, team competence, and comprehensive service offerings including BRH solutions—you can select a partner that will not only navigate current regulatory requirements but also position your organization for future success in Brazil’s dynamic medical device market. 📩 For more information on regulatory consulting services and BRH solutions, consult qualified specialists 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 

Introduction The Medical Device Single Audit Program (MDSAP) represents a paradigm shift in regulatory compliance for medical device manufacturers seeking access to the global market. By harmonizing quality management system audits across multiple jurisdictions, MDSAP offers unprecedented cost-efficiency and time-to-market advantages that can define competitive positioning in today’s complex regulatory environment. Understanding MDSAP: A Multi-Jurisdictional Approach MDSAP allows medical device companies to undergo a single regulatory audit that satisfies the requirements of participating regulatory authorities, including the U.S. FDA, Health Canada, Brazil’s ANVISA, Australia’s Therapeutic Goods Administration (TGA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). This revolutionary approach eliminates the traditional need for separate audits by each medical device authority, creating substantial operational efficiencies for manufacturers planning international expansion. Cost-Reduction Strategies Through MDSAP Implementation 1. Benefits of Audit Consolidation Traditional regulatory compliance required separate audits for each target market. A company seeking access to all MDSAP-participating countries would traditionally face: MDSAP transforms this fragmented approach into a unified audit process, reducing overall compliance costs compared to individual country-by-country audits. 2. Resource Optimization Manufacturers can redirect internal resources from managing multiple audit processes to core business activities. This includes: 3. Accelerated Market Access Timeline The synchronized audit approach significantly reduces time-to-market for new products. While traditional approaches may require 12–18 months for multi-country regulatory approval, MDSAP-certified companies can achieve earlier market entry across all participating jurisdictions. Strategic Implementation for the Brazilian Market For companies targeting the Brazilian market, MDSAP offers particular advantages when working with ANVISA. The program aligns with current Good Manufacturing Practices (GMP) requirements, which are mandatory for Class III and IV registration processes. Key Brazilian Market Considerations: Competitive Positioning Through MDSAP Certification Market Differentiation MDSAP certification serves as a quality differentiator in competitive tenders and procurement processes. Healthcare institutions and distributors increasingly prefer suppliers with demonstrated multi-jurisdictional compliance capabilities. Scalability Advantages Certified companies can quickly expand into new MDSAP markets without major additional audit investments, creating significant first-mover advantages in emerging opportunities. Risk Mitigation The comprehensive nature of MDSAP audits often identifies and addresses quality system gaps that might go unnoticed in single-jurisdiction audits, reducing long-term compliance risks. Best Practices for Implementation Pre-Certification Preparation Ongoing Compliance Management The Strategic Imperative MDSAP certification represents more than regulatory compliance—it is a strategic business decision that can fundamentally alter market entry economics and competitive positioning. Companies that embrace this harmonized approach gain substantial advantages in cost structure, time-to-market, and operational efficiency. For medical device manufacturers planning global expansion, MDSAP should be considered an essential component of market entry strategy, offering quantifiable benefits that directly impact financial performance and competitive sustainability. For more information on MDSAP implementation and regulatory market entry strategies, contact our specialized medical device consulting team. 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 

Introduction  The Brazilian medical device market presents significant opportunities for international manufacturers, but navigating the regulatory landscape requires expertise in ANVISA requirements. Understanding the role of the Brazilian Registration Holder (BRH) is crucial for foreign companies seeking to establish a successful presence in Brazil’s healthcare sector.  What is a Brazilian Registration Holder (BRH)?  The Brazilian Registration Holder (BRH) is a legal entity established in Brazil that assumes responsibility for registering medical devices and conducting post-market surveillance activities on behalf of foreign manufacturers. This regulatory requirement ensures that international companies maintain local representation for compliance and communication with ANVISA.  Key Responsibilities of the Registration Holder  The BRH serves as the official interface between foreign manufacturers and Brazilian regulatory authorities, such as INMETRO, ANATEL, and ANVISA. Core responsibilities include:  Regulatory Framework and Current Requirements  Key Regulations Governing BRH Operations  RDC 751/2022 – Current Registration Framework RDC 751/2022 represents the current standard for medical device registration in Brazil, establishing comprehensive requirements for product classification, clinical evidence, and quality management systems.  RDC 665/2022 – GMP Requirements RDC 665/2022 continues to serve as the foundation for Good Manufacturing Practices (GMP) in Brazil, aligning with international GMP standards and supporting MDSAP recognition.  International Harmonization Efforts  Brazil’s participation in the Medical Device Single Audit Program (MDSAP) demonstrates a commitment to international harmonization. This program allows manufacturers to undergo a single audit that satisfies regulatory requirements across multiple jurisdictions.  Laboratory-Developed Tests (LDTs)  The BRH plays a critical role in supporting the registration and compliance of Laboratory-Developed Tests, including:  Choosing the Right BRH Partner  Essential Criteria for BRH Selection  When evaluating potential BRH partners, manufacturers should consider:  Due Diligence Process  A thorough assessment should include:  Implementation Strategy  Establishing BRH Relationships  Successful BRH implementation requires:  Market Access Benefits  Accelerated Registration Timelines  An experienced BRH can significantly reduce registration timelines through:  Cost Optimization  Professional BRH services provide cost benefits through:  Future Regulatory Developments  Emerging Trends  Brazil’s medical device regulations continue to evolve, with key developments including:  Conclusion  The Brazilian Registration Holder (BRH) serves as a critical partner for foreign medical device manufacturers seeking success in Brazil’s dynamic healthcare market. By understanding BRH requirements, selecting qualified partners, and implementing robust compliance strategies, international companies can effectively navigate ANVISA regulations while focusing on their core mission of improving patient outcomes.  Success in Brazil’s medical device market requires more than regulatory compliance—it demands strategic partnership with experienced medical device consultants who understand ANVISA’s complexities and can provide the local expertise needed for sustainable market access.  Contact us to discuss your specific needs and discover how our BRH services can accelerate your path to success in the Brazilian market. Let us handle the regulatory complexities while you focus on bringing innovative healthcare technologies to Brazilian patients.  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 

Understanding the Medical Device Classification Framework The Foundation of Regulatory Compliance Medical device classification serves as the cornerstone of regulatory oversight, determining the level of scrutiny and control measures required for each product category. Under Brazil’s current regulatory framework, particularly RDC 751/2022, devices are systematically categorized based on their potential risk to patients and users. The classification system recognizes four distinct risk categories: Key Classification Criteria Several fundamental factors influence device classification: The Critical Impact of Invasive and Implantable Devices Considerations for Invasive Devices Invasive medical devices present unique classification challenges due to their direct interaction with patient anatomy, requiring comprehensive risk assessment protocols. Common categories of invasive devices include: Medical device consultants emphasize that invasive devices often require enhanced clinical evidence, biocompatibility testing, and specialized Good Manufacturing Practice (GMP) compliance protocols. Complexities of Implantable Devices Implantable devices represent the most complex category, often classified as Class III or IV due to their permanent or long-term presence within the human body. These devices require: Examples include cardiac pacemakers, orthopedic implants, neural stimulators, silicone implants, and drug-eluting stents. The classification process for implantable devices requires detailed analysis of material composition, mechanical properties, and potential biological interactions. Regulatory Framework Updates and Current Requirements Recent Regulatory Evolution Brazil’s medical device regulatory landscape has undergone significant transformation with the implementation of RDC 751/2022, which replaced previous regulations and aligned Brazilian requirements more closely with international standards. This modernization reflects ANVISA’s commitment to harmonizing with global regulatory frameworks while maintaining the unique needs of the Brazilian market. Benefits of MDSAP Integration The Medical Device Single Audit Program (MDSAP) has streamlined quality management system assessments for manufacturers seeking multiple market approvals. Brazilian companies participating in MDSAP benefit from: International Harmonization and Market Access Proper classification facilitates international market expansion by ensuring alignment with global regulatory authorities. Best Practices for Classification Success Leading medical device authorities recommend: Specialized Consulting Support Given the complexity of device classification, many companies benefit from specialized medical device consulting services that provide: Conclusion The critical importance of proper medical device classification cannot be overstated in today’s complex regulatory environment. Accurate classification serves as the foundation for regulatory compliance, patient safety, and successful market access within Brazil’s dynamic healthcare sector. Companies investing in comprehensive classification strategies, supported by expert consulting and continuous regulatory monitoring, position themselves for sustainable success in Brazil’s growing medical device market. As regulatory frameworks continue to evolve, maintaining classification accuracy remains essential to protect patients while enabling innovative healthcare solutions to reach those who need them most. For organizations navigating Brazil’s medical device regulatory landscape, prioritizing proper classification represents both a regulatory requirement and a strategic business advantage supporting long-term market success. 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 

Introduction  The regularization of medical devices with ANVISA is a complex process that requires in-depth technical knowledge and attention to regulatory details. With the implementation of RDC 751/2022 and other current regulations, it is essential that companies in the medical device sector adopt efficient practices to avoid rejections and procedural delays.  This guide presents 9 essential practices based on our experience and knowledge of the main Brazilian regulatory requirements.  1. Ensure Complete Document Delivery  Recommended Practices:  Avoid:  2. Keep Documents Updated  Recommended Practices:  Special Attention:  3. Present Clinical Evidence for Technological Innovation  Recommended Practices:  Importance: Clinical evidence is fundamental for products with indications or technologies not established in the Brazilian market.  4. Classify the Product Correctly  Recommended Practices:  5. Pay the GRU Correctly and On Time  Recommended Practices:  Attention: Incorrect payment can delay the entire process and generate financial loss.  6. Be Prepared for Additional Requirements  Recommended Practices:  Avoid:  7. Labeling and IFU According to Current Legislation  Recommended Practices:  Practical Tip: Check current resolutions to ensure no information is missing in IFUs.  8. Pay Attention to Quality and Presentation of Submission  Recommended Practices:  Benefits: Professional presentation accelerates the analysis process and demonstrates company seriousness.  9. Rely on Specialists to Avoid Errors and Reduce Risks  Recommended Practices:  Conclusion  Safe submission of processes to ANVISA requires adequate preparation, specialized technical knowledge, and attention to regulatory details. Following these 9 essential practices significantly increases approval chances in the first analysis cycle, avoiding additional costs and delays in product launches.  For companies seeking regulatory excellence, investment in specialized medical device consulting is fundamental to safely navigate the complex Brazilian regulatory environment and maximize growth opportunities in the medical device 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 

September 1st, 2025 – Essential Information for Medical Device Importers  The National Health Surveillance Agency (ANVISA) has announced a crucial webinar scheduled for September 1st, 2025, at 10 AM (Brasília time), focusing on remote inspection procedures for imported products subject to health surveillance. This virtual seminar represents a significant advancement in the Brazilian regulatory framework for medical device importers and health product stakeholders.  Key Details: Remote Inspection Webinar  Date: September 1st, 2025 Time: 10 AM (Brasília time) Topic: Remote Inspection of Imported Cargo in Bonded Warehouses Registration: No prior registration required Access Link: Join the Webinar  This initiative aligns with ANVISA’s transparency objectives, providing updated content and knowledge for professionals involved in importation and regulatory compliance.  Importance for Medical Device Authority Compliance  The webinar addresses critical developments in inspection procedures that directly impact importers of health-regulated products. ANVISA continues to modernize its surveillance processes, making remote inspection capabilities a cornerstone of efficient regulatory oversight.  Expected main topics include:  Regulatory Context and Current Framework  Brazil’s health surveillance regulations establish comprehensive requirements for imported medical devices and health products. The remote inspection methodology represents ANVISA’s commitment to maintaining rigorous oversight while optimizing processes for compliant importers.  Strategic Benefits for Importers  Participation in this webinar offers several advantages:  How to Participate  To join the webinar, access the webinar link on the scheduled date and time. No prior registration is required, making access convenient for all interested professionals.  Conclusion  This webinar represents a valuable opportunity for importers and medical device professionals to stay updated with the latest developments in ANVISA inspection procedures. Participation contributes to more efficient and compliant import operations, benefiting the entire health product supply chain in Brazil.  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