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were officially released, establishing updated requirements for sanitizing product regularization and replacing the outdated RDC 59/2010.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

Most international tenders are for registering prices in foreign currency Jonas Lima¹ 1. Concept and Legal Definition of International Bidding From a doctrinal perspective, an international bidding process is a mandatory procurement procedure when, due to limitations or conditions of the domestic market, the State must expressly invite foreign bidders—through national and international means of publication—to participate in the competition. The bidding notice is specifically designed for this purpose. Law No. 14,133/2021 was the first to provide a legal definition: “Art. 6. For the purposes of this Law, the following are considered: (…)XXXV – international bidding: bidding conducted in national territory in which the participation of foreign bidders is allowed, with the possibility of price quotations in foreign currency, or bidding in which the contractual object may or must be carried out wholly or partially abroad.” It is essential that public notice ensures equal treatment, in accordance with Article 37 of the Federal Constitution, so that both Brazilian and foreign bidders have equal access to information about opportunities to contract with the Brazilian government. In this context, serious criticism is made of “national tenders” that merely allow the participation of foreigners—an approach that often results in considerable losses—when a true international bidding process, including a notice designed to ensure full and effective competition among foreign bidders, should have been adopted. 2. Focus of the Article – Foreign Currency The paradigm that pricing in foreign currency in public procurement leads to loss of cost-efficiency needs to be overcome. In practice, the opposite effect is observed: a significant increase in cost-efficiency and advantage in international procurement procedures. Data from the former Comprasnet platform and other systems, including the National Public Procurement Portal, show that more than half of international bids are for registering prices in foreign currency. This phenomenon is explained by the increased competitiveness and alignment with the principles of the Public Procurement Law.         3. Article 12, Item II of Law No. 14,133/21 and Systematic Integration The referenced provision states that: “Values, prices, and costs used must be expressed in national currency, except as provided in Article 52 of this Law.” This exception is not a mere procedural deviation but a specific rule recognizing the need to adapt to the particularities of international trade. The systematic coherence between Articles 12(II) and 52 of Law No. 14,133/21 shows that the legislator not only allowed but encouraged the use of foreign currency in international bids. Article 52 establishes that, in international bids, the notice must conform to monetary policy and foreign trade guidelines and comply with the requirements of the competent agencies. Paragraph 1 states that: “When foreign bidders are allowed to quote prices in foreign currency, Brazilian bidders may do so as well,” and paragraph 2 adds: “Payments made to Brazilian bidders eventually contracted under the terms of §1 shall be made in national currency.” This regulatory framework enables competitiveness, equal treatment, and advantageous procurement. Practice clearly shows that trying to conduct international bidding with national currency only is extremely detrimental. 4. Harmonization with Exchange Regulations Law No. 14,286/21, which governs the Brazilian foreign exchange market, in Article 13(I and IX), allows payment obligations enforceable in Brazilian territory to be denominated in foreign currency for: This includes contracts resulting from international tenders. This provision updates Article 1, sole paragraph, item I of Law No. 10,192/01, which already made exceptions for payment obligations in foreign currency when authorized by law or Central Bank regulation, as well as Article 318 of the Civil Code, which prohibited such arrangements except where provided by special legislation. Thus, the provisions of the Public Procurement Law are now aligned and consistent with exchange control legislation. 5. Advantage and Competitiveness The principle of competitiveness, enshrined in Article 5 of Law No. 14,133/21, finds practical application in price quotations in foreign currency. Foreign companies often hesitate to participate in bids requiring pricing in Brazilian reais, drastically reducing the number of participants—and, consequently, competition. Practice shows that national tenders that attempt to attract foreign participants but require pricing in reais yield negligible results in terms of savings or efficiency. In many cases, only Brazilian intermediaries participate, reselling already nationalized products—resulting in substantial losses for the public purse. Pricing in foreign currency is therefore an inherent and essential element of true international competition. One of the objectives of public procurement, according to Article 11(I) of Law No. 14,133/21, is to select the proposal that offers the most advantageous result for the Public Administration. Foreign currency pricing directly contributes to this, as exchange rate fluctuations are offset by the savings gained through increased competition and reciprocal tax immunity (when importing through a public entity’s CNPJ). The reduction in tax burden alone often exceeds 60% or 70%, depending on the product’s NCM code, due to Article 150(VI)(a) of the Federal Constitution, which prohibits the taxation of property, income, or services of the Union, States, Federal District, and Municipalities—benefiting imports carried out by the Public Administration and expanding cost-efficiency in international bids. This dual benefit—savings from competitiveness and tax immunity—more than compensates for exchange rate fluctuations, resulting in undeniable advantage for the Public Administration. 6. Operational and Regulatory Aspects The operational framework established by law preserves monetary sovereignty by requiring that Brazilian bidders contracted in international processes be paid in national currency, with currency conversion done at the time of the bank transaction, in accordance with foreign exchange regulations. For foreign suppliers, payment is made using typical international trade instruments, such as letters of credit for goods imports or international transfers for services—maintaining alignment with monetary policy and foreign trade guidelines. 7. Conclusions A systematic reading of Article 12(II) of Law No. 14,133/21 shows that quoting in foreign currency in international tenders not only has solid legal grounding—consistent with foreign exchange rules—but is also essential for implementing the principles of competitiveness, cost-efficiency, and advantageous procurement. Far from being a barrier, the use of foreign currency proves to be a tool for enhancing the efficiency and value of public contracting. ¹

Introduction  The Brazilian medical device market represents one of the largest opportunities in Latin America, with trade shows and events serving as crucial platforms for international manufacturers to showcase their innovations. Understanding the regulatory framework for importing medical devices specifically for exhibition purposes is essential for companies planning to participate in major events like Hospitalar and other health fairs in Brazil.  ANVISA’s Regulatory Framework for Exhibition Imports  The Brazilian Health Regulatory Agency (ANVISA) has established specific pathways for the temporary import of medical devices intended exclusively for demonstration and exhibition purposes. These regulations, primarily governed by RDC 751/2022 and other relevant RDCs, provide a streamlined process that differs significantly from standard commercial import procedures.  Key Regulatory Distinctions  Imports for exhibition are subject to different requirements compared to commercial imports, particularly regarding:  Documentation Requirements for Exhibition Imports  Essential Documentation  ANVISA Submission Process  Companies must submit their import requests for exhibition through ANVISA’s official channels, ensuring all documentation aligns with current RDC requirements. The submission process typically requires:  Compliance Considerations for Different Device Classes  Class I Devices  Class II and III Devices  Software as a Medical Device (SaMD)  For SaMD products, additional considerations include:  Strategic Advantages of Exhibition Participation  Market Access Benefits  Participating in Brazilian trade shows provides:  Medical Device Consulting Partnerships  Working with specialized medical device consulting firms can significantly simplify the exhibition import process through:  Post-Event Compliance Requirements  Device Disposal  All exhibition devices must be:  Documentation Retention  Companies must retain comprehensive records of:  Technological Integration and Future Trends  Laboratory Developed Tests (LDTs)  The evolving landscape of laboratory developed tests presents new opportunities for exhibition participation, particularly for diagnostic device manufacturers seeking to demonstrate innovative testing solutions.  Digital Health Solutions  Modern exhibition strategies increasingly incorporate:  Best Practices for Successful Exhibition Participation  Pre-Event Planning  During the Exhibition  Post-Event Follow-up  Conclusion  Successfully importing medical devices for exhibition in Brazil requires careful attention to ANVISA’s regulatory framework and compliance with current RDCs. Companies that invest in proper planning, documentation, and medical device consulting support can leverage these events to build significant market presence and regulatory relationships. As events like Hospitalar continue to grow in importance, understanding these regulatory pathways becomes increasingly critical for international medical device manufacturers seeking to enter the Brazilian market.  For companies planning exhibition participation, early engagement with ANVISA and specialized regulatory consultants ensures smooth import processes and successful event outcomes.    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 In June 2025, Anvisa officially introduced the Unique Device Identification System (SIUD), marking a significant milestone in the regulation of medical devices in Brazil. This new identifier implements international standards that will revolutionize traceability and product safety in the Brazilian healthcare market. What is the UDI System? Definition and Purpose UDI (Unique Device Identification) is an international standard defined by the International Medical Device Regulators Forum (IMDRF) aimed at enabling the unique identification of medical devices. In Brazil, this system is regulated by RDC 591/2021, which establishes the requirements for the implementation of unique device identification. Components of the UDI System The UDI system consists of two main elements: Regulatory Implementation in Brazil Regulatory Milestones The implementation of UDI in Brazil aligns with global best practices of medical device authorities and follows a timeline established by Anvisa’s RDCs. The system applies to different classes of medical devices, including SAMD (Software as a Medical Device). Key Requirements of RDC 591/2021 The main requirements include: Benefits of the UDI System For the Industry Key identified benefits: For the Healthcare System Implementation Timeline Phases of Implementation Company Preparation Companies in the sector should consider: International Harmonization Benefits of Harmonization Technical and Operational Aspects SIUD System The Unique Device Identification System (SIUD) is the national platform that: Impact on Health Surveillance Strengthening Oversight The UDI strengthens health surveillance through: Preparing for Compliance Essential Steps To ensure UDI compliance: Conclusion The UDI system marks a major advancement in the regulation of medical devices in Brazil, aligning the country with the highest international standards of safety and traceability. Successful implementation requires collaboration between Anvisa, the industry, and medical device consulting service providers. Next Steps Companies should begin compliance preparations immediately, considering the deadlines set by RDC 591/2021 and seeking specialized support. Source: Anvisa – UDI System and Regulatory Updates 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 New UDI Requirements of RDC 884/2024  The Brazilian Health Regulatory Agency (ANVISA) has set new deadlines for the implementation of Unique Device Identification (UDI) through RDC 884/2024, marking a significant milestone in medical device regulatory compliance in Brazil. This comprehensive guide will help manufacturers, importers, and distributors understand the implementation timeline and prepare for compliance.  Implementation Schedule by Risk Class  RDC 884/2024 establishes specific deadlines based on the risk classification of medical devices:  Essential UDI Data Elements for the ANVISA Database  According to the regulatory framework, registration or notification holders must provide comprehensive information to the UDI database, including:  Core Product Information  Manufacturer and Commercial Data  Technical Specifications  Additional Requirements  UDI Issuing Entities  UDI-DI and UDI-PI numbers must be issued by specific authorized entities:  How Medical Device Consulting Companies Can Support Implementation  Registration and Notification Support  Medical device consulting companies can assist businesses by:  Documentation Preparation  Consultants can help prepare essential documentation including:  Considerations for Software and SaMD  For Software as a Medical Device (SaMD) products, special attention must be given to:  Implementation Strategy for Different Company Types  For Manufacturers  For Importers and Distributors  Similar to FDA registration processes, importers should:  Integration with Existing Regulatory Processes  UDI implementation functions as a secondary process that must be completed after registration/notification approval, similar to the requirements for submitting Instructions for Use (IFU) in Portuguese.  Preparing for Compliance  Immediate Actions Required  Long-Term Strategic Planning  Conclusion  The implementation of UDI requirements under RDC 884/2024 represents a significant advancement in medical device traceability and patient safety in Brazil. Companies should begin preparations immediately, especially those with Class IV devices facing the July 2025 deadline.  Working with experienced medical device consulting professionals can significantly streamline the implementation process, ensuring compliance while minimizing business disruptions. The key to successful implementation lies in early preparation, a systematic approach, and leveraging the expertise of regulatory consultants familiar with ANVISA 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 

Introduction  Health inspections conducted by ANVISA represent a pivotal moment for companies in the medical device sector in Brazil. With increasing regulatory stringency and the implementation of new guidelines, proper preparation through specialized medical device consulting services has become essential for business success.  The Current Landscape of Health Inspections in Brazil  The National Health Surveillance Agency (ANVISA) has intensified its inspection activities, especially following the publication of RDC 751/2022, which establishes stricter criteria for Good Manufacturing Practices (GMP) for medical devices. This regulation, which replaces previous standards, marks a milestone in aligning Brazilian regulatory practices with international standards.  Main Challenges Faced by Companies  During health inspections, companies frequently encounter:  The Pre-Audit Strategy: Ensuring Regulatory Success  What Is a Pre-Audit?  A pre-audit is a comprehensive and systematic assessment of a company’s processes, documentation, and infrastructure, conducted by medical device regulatory experts before the official ANVISA inspection.  Proven Benefits of Pre-Audit  Key Aspects Assessed During ANVISA Inspections  RDC 751/2022 sets specific requirements for quality management systems, including:  ANVISA inspectors rigorously assess:  With the progressive implementation of the UDI system in Brazil, companies must demonstrate:  Harmonization with International Standards  Alignment with Global Regulatory Authorities  Brazilian regulations are increasingly aligned with:  Benefits of Regulatory Harmonization  This alignment facilitates:  Specialized Sectors and Industry Events  Technology and Innovation  For companies working with advanced technologies, including SAMD and identifier software, pre-audit is especially critical due to the regulatory complexity of these products.  Participation in Industry Events  Events like Hospitalar 2024 highlight the growing importance of regulatory compliance in the sector. Participation in such events, combined with a strong compliance strategy, strengthens companies’ competitive position.  Implementing an Effective Pre-Audit Program  Phase 1: Initial Assessment  Phase 2: Action Plan Development  Phase 3: Implementation and Verification  Phase 4: Final Preparation  Regulatory Communication and Updates  The Importance of the Regulatory Newsletter Radar  Staying up to date through reliable sources such as specialized newsletters is essential to monitor regulatory changes and prepare effectively for inspections.  Communication Channels with Authorities  Establishing effective contact channels with ANVISA and other regulatory authorities helps clarify doubts and proactively resolve regulatory issues.  Specific Considerations for Different Device Types  High-Risk Products  For high-risk medical devices, pre-audit should include:  Software as a Medical Device (SAMD)  For SAMD, specific aspects include:  Pre-Audit ROI: Cost-Benefit Analysis  Avoided Costs  Measurable Benefits  Conclusion  Implementing a robust pre-audit program is a strategic investment for companies in the Brazilian medical device sector. With the increasing complexity of ANVISA regulations and the need to align with international standards, proper preparation through specialized medical device consulting is not just advisable—it is essential for business success.  RDC 751/2022 and other current regulations establish a strong regulatory framework that, when properly implemented through pre-audit processes, ensures not only regulatory compliance but also operational excellence and competitiveness in both domestic and international markets.    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