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 

Introduction  Anvisa, Brazil’s regulatory authority for health-related products, has published revolutionary new regulations that will reshape the sanitizing products market in Brazil and Mercosul countries. On August 20, 2025, Resolution RDC 989/2025 and Normative Instruction IN 394/2025 were officially released, establishing updated requirements for sanitizing product regularization and replacing the outdated RDC 59/2010.  These new RDCs represent a significant milestone in regulatory harmonization, aligning Brazilian legislation with Mercosul technical regulations while maintaining national specificities that ensure product safety and facilitate market access.  Development Process and Background  The regulatory revision process began in 2019 during the 50th Meeting of Mercosul’s Working Subgroup (SGT) No. 11 in Buenos Aires. The main objective was to align Brazilian legislation with the proposed technical regulation for registration and notification of sanitizing products throughout the Mercosul bloc.  After extensive consultation through Public Consultation 776 published on February 7, 2020, the health-related products regulatory authority faced challenges in achieving complete harmonization due to climatic differences between Mercosul countries. This led to disagreements regarding analytical tolerances and shelf-life requirements (Chapters VI and VIII of the former RDC 59/2010).  To address these challenges while maintaining regulatory progress, Anvisa adopted a strategic two-part approach:  RDC 989/2025: Contains the harmonized Mercosul text IN 394/2025: Addresses non-harmonized requirements from the former RDC 59/2010, including analytical tolerances and shelf-life criteria  Main Changes and Regulatory Requirements  Risk Classification System  The new regulations establish a clear risk classification system for sanitizing products:  Risk Category 1 (Mandatory Notification): Products requiring notification procedures Risk Category 2 (Mandatory Registration): Products requiring formal registration  LD50 evaluation criteria have been significantly refined:  This specification provides greater precision and standardization in risk assessment, considering different presentation forms and usage patterns of sanitizing products.  Enhanced Safety Requirements  The regulations introduce stringent safety requirements including:  Labeling and Packaging Standards  Harmonized labeling requirements ensure greater clarity and consumer safety:  Mandatory Information Requirements:  Prohibited Practices:  The labeling system now offers more complete and consistent requirements applicable to all sanitizing product categories, ensuring comprehensive regulatory compliance.  Volume Limits for Free-Sale Products  Risk Category 1 products designated for free sale can now be commercialized in containers up to 10 kg or liters, providing greater flexibility for manufacturers while maintaining safety standards.  National Specificities in IN 394/2025  IN 394/2025 details critical national requirements:  Impact Analysis and Industry Implications  Benefits for Citizens and Public Health  The new regulatory framework offers significant advantages:  Industry and Market Impact  For the productive sector, these regulations provide:  Regulatory Compliance Strategies  For Manufacturers Currently in Market  Existing product holders should:  For New Market Entrants  Companies seeking market entry should:  International Harmonization and Mercosul Integration  The regulatory alignment represents a strategic milestone in Mercosul integration, facilitating:  Future Perspectives and Regulatory Evolution  Anvisa’s commitment to regulatory modernization suggests continued evolution in:  Conclusion and Recommendations  The publication of RDC 989/2025 and IN 394/2025 represents a transformative moment for Brazil’s sanitizing products sector. These regulations demonstrate Anvisa’s commitment to public health protection while facilitating market access and international competitiveness.  Key recommendations for stakeholders:  The regulatory landscape continues evolving, and successful companies will be those that proactively adapt to these changes while leveraging new opportunities for growth and market expansion.  For additional guidance and regulatory support, stakeholders should consider contacting Anvisa through official channels or engage specialized medical device consulting services familiar with Brazilian regulatory requirements.  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 

ANVISA has officially launched the public consultation process for the Regulatory Agenda 2026-2027, representing a fundamental strategic opportunity for medical device manufacturers and industry companies to influence Brazilian regulatory priorities for the next two years. Timeline and Participation Process Consultation Period: August 15 to September 15, 2025 Target Audience: Society and entities of the National Health Surveillance System (SNVS) Method: Electronic forms according to Public Call Notice 10, dated 8/14/2025 Preliminary List: 115 Strategic Regulatory Themes The preliminary list of the 2026-2027 Regulatory Agenda presents a comprehensive set of 115 regulatory themes, strategically distributed as: This composition offers unprecedented opportunities for medical device authority stakeholders to influence critical areas, including: Guidelines for Effective Participation The health products regulatory authority establishes clear criteria for effective contributions: Important: The more well-founded the manifestations, the greater their contribution to technical analysis and theme prioritization by the medical products agency. Strategic Webinar for Industry Professionals Date: Thursday, August 21, 2025 Time: 10:00 AM (Brasília time) Theme: “Building the 2026-2027 Regulatory Agenda: Preliminary Theme List Notice” Free access – no prior registration required. This session will present fundamental elements of AR 2026-2027 and specific guidelines for submitting contributions. Available Documentation ANVISA provides two versions of the preliminary list: Strategic Importance for the Sector The Regulatory Agenda functions as an essential planning instrument that provides predictability and transparency to normative regulatory activity. For companies and specialized consultants, this means: Comprehensive Sectoral Impact This public consultation directly impacts stakeholders involved in: Finalization Process It is essential to understand that this consultation on the preliminary list represents a moment of collecting contributions to support the construction of the final list of themes, which will be approved by ANVISA’s Collegiate Board by the end of 2025. Therefore, this is not yet the definitive version of the 2026-2027 Regulatory Agenda. Value of Social Participation The participatory construction of the Regulatory Agenda is a prominent guideline at ANVISA, reflecting society’s contributory value for aligning the Agency’s regulatory actions with its mission to protect and promote population health. This public consultation represents a unique opportunity to shape the Brazilian regulatory environment, ensuring that industry needs are considered in regulatory planning for the next two years. Strategic Conclusions: Reference Source: ANVISA Official News – Regulatory Agenda 2026-2027 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 

Medical devices play a fundamental role in the practice of modern medicine, offering a variety of essential tools for diagnosis, treatment, and monitoring of health conditions. These devices range from simple equipment such as thermometers and glucose monitors to advanced technologies like magnetic resonance imaging and medical implants. By enabling early disease detection, enabling less invasive procedures, and ensuring more efficient monitoring, medical devices contribute significantly to the advancement of health and well-being of the population.  Among the various types of medical devices – as defined by RDC nº 751/2022 – in vitro diagnostic medical devices stand out due to their multiple applications in the healthcare field. Because it is a complex and specialized regulatory subject, in vitro diagnostic products (IVDs) are governed by a specific resolution: RDC nº 830/2023.  By definition, an IVD is a reagent, software, sample collector, or other article used for the in vitro analysis of samples derived from the human body, exclusively or primarily, with the purpose of providing information for diagnostic, monitoring, compatibility, screening, or determination of physiological status.  The classification is carried out following the guidelines of RDC nº 830/2023, according to the most applicable rule for the product. Following this analysis and determination of the class, the process of petitioning for notification or registration with ANVISA begins.  The classification establishes the type of process that will be submitted: IVD products of Class I and II are subject to notification, while those of Class III and IV are subject to registration. In the case of notifications, the technical analysis of documents by ANVISA constitutes a more simplified process. Specifically for Class I, it is not   necessary to prepare a technical dossier, only to submit certain information. For products targeted for registration, it is necessary to submit, in addition to the technical dossier, a Good Manufacturing Practice (GMP) Certificate process to ANVISA as a prerequisite.  According to Regulatory Instruction nº 320, dated September 2024, in vitro diagnostic medical devices that are included in a grouping list for IVD families can be registered or grouped as a family, provided that a series of requirements are met. These include the stipulation that they must be products of the same composition, technology, legal manufacturer, and intended for interdependent and exclusive use.  Furthermore, besides the mentioned documents, an IVD product may also require a Conformity Certificate or a pre-analysis report deemed satisfactory by a unit of the National Network of Public Health Laboratories (INCQS). This applicability should be evaluated on a case-by-case basis, according to the specificities of the product.  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 

As of June 2025, ANVISA has implemented a strategic change that demonstrates its commitment to optimizing regulatory processes in the pharmaceutical and medical device sectors. What changed in practice? BEFORE: The renewed Good Manufacturing Practice Certificate (CBP) validity started from the publication date, creating temporal discontinuity. NOW: The renewal validity starts exactly on the last day of the current certification, ensuring perfect continuity. Practical example: Key benefits: For companies: For the regulatory system: Impact on the Consultation Portal An important change: renewals published before the current certification expires will not appear on the Portal until they are effectively in force, avoiding confusion and ensuring clarity in consultations. Industry reflection This change reflects Brazilian regulatory maturity, prioritizing operational efficiency and legal certainty. For regulatory affairs professionals, it represents further evidence of the importance of continuously monitoring ANVISA updates. How is your company preparing for these regulatory changes? 💬 Share your experience in the comments about how these changes impact your processes Need regulatory affairs consulting? Contact me to discuss how I can help your company navigate these changes. 📎 Reference:ANVISA. Anvisa altera forma de contagem da validade do Certificado de Boas Práticas. Available at: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2025/anvisa-altera-forma-de-contagem-da-validade-do-certificado-de-boas-praticas. Accessed: Aug. 2025. #ANVISA #RegulatoryAffairs #GoodPractices #Pharmaceutical #RegulatoryQuality #CBP #BrazilianRegulation

IntroductionThe concept of family in medical device regulation represents a sophisticated approach to optimize regulatory processes while maintaining safety and efficacy standards. Under Brazil’s RDC 751/2022, the family classification system provides significant advantages for manufacturers seeking efficient pathways for medical device registration in the national market. Regulatory Definition According to RDC 751/2022, a family consists of a group of medical devices intended for notification or registration, as defined by specific regulation. Each product in the family must share similar technical characteristics across five key dimensions: Strategic Advantages Regulatory Efficiency Family registration under RDC 751/2022 enables manufacturers to leverage documentation across multiple related products, significantly reducing the documentation burden and accelerating market access. This approach facilitates the entry and maintenance of multiple products in the market. Cost Optimization · Lower regulatory fees· Simplified documentation requirements· Shared technical evaluations· Economies of scale in regulatory processes Faster Product Development · Accelerated product line extensions· Shorter time-to-market for variants· Improved competitive positioning· Optimized allocation of resources Technical Requirements Standardized Documentation Family submissions must demonstrate technical equivalence through standardized documentation, covering:· Comparative risk analysis· Shared manufacturing processes· Common components· Harmonized regulatory requirements Regulatory Pathways Notification vs. Registration Under RDC 751/2022, family classification affects regulatory routes:· Class I–II Devices: Subject to notification procedures· Class III–IV Devices: Require full registration processes Classification Considerations All products within a family must demonstrate consistent risk profiles and a justified classification. ANVISA’s requirements dictate that risk assessment methodologies must be aligned across all family members. Practical Implementation Aspects Required Documentation To submit a family registration, manufacturers must provide, among others:· ANVISA forms· Technical dossier· Evidence of technical equivalence· Safety and performance analysis· Demonstration of GMP compliance (if applicable) Market Access Strategy Strategic planning based on families enables:· Accelerated product line extensions· Reduced time-to-market· Improved competitive positioning· Optimized use of regulatory resources Sustainable Competitive Advantage Family registration offers long-term regulatory and market benefits:· Simplified regulatory maintenance· Lower registration costs· Faster innovation cycles· Greater responsiveness to market demands Challenges and Considerations Technical Complexity · Need for strict demonstration of technical equivalence· Maintaining consistency across multiple products· Managing technical changes over time Conclusion The family classification system under RDC 751/2022 is a sophisticated regulatory tool that balances operational efficiency with high safety standards. For manufacturers navigating Brazil’s complex regulatory landscape, family strategies provide competitive advantages in cost, speed, and market access. Implementing family concepts strategically requires a thorough understanding of technical requirements, regulatory pathways, and quality system implications. Organizations aiming to optimize their market strategy in Brazil should consider family approaches as integral components of their regulatory planning. Successful implementation of medical device families depends on careful planning, rigorous documentation, and consistent quality standards across all grouped products. With the right approach, family strategies represent a significant opportunity for regulatory optimization and sustainable competitive advantage. For expert guidance on family registration strategies and RDC 751/2022 compliance, contact our specialists to discuss your specific needs and develop a customized strategy for registering your medical device 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 w