Medical devices play a crucial role in the diagnosis, prevention, monitoring, and treatment of diseases. To ensure that these products maintain their safety, efficacy, and quality over time, ANVISA (Brazilian Health Regulatory Agency) in Brazil implements periodic reassessment processes.  What is the Reassessment of Medical Devices?  The reassessment of medical devices is a regulatory process that analyzes already registered products to verify if they continue to meet safety and efficacy requirements according to the latest scientific and technological advancements. This process is fundamental for the protection of public health and to ensure that medical devices available on the Brazilian market remain suitable for use.  Legal Basis in Brazil  In Brazil, the reassessment of medical devices is mainly regulated by RDC 751/2022, which establishes the procedures for registration, modification, revalidation, and cancellation of the registration of medical products. This resolution replaced previous regulations and brought important updates to align Brazil with international best practices in medical device regulation.  RDC 848/2024 also addresses aspects related to the safety and continuous monitoring of devices, being crucial for the reassessment process.  Technical Triggers for Reassessment  The reassessment of a medical device can be initiated for different reasons:  Technical Process of Reassessment   Critical Technical Aspects  Quality Systems  Compliance with Good Manufacturing Practices is verified during the reassessment, focusing on:  Software as a Medical Device (SaMD)  For SaMDs, the reassessment incorporates verification of:  Harmonization with International Parameters  The process aligns with the practices of international agencies, adopting:  Technical Strategies for Compliance  For efficiency in the reassessment process, the following is recommended:  Technical-Regulatory Implications  The reassessment ensures:  Conclusion  The medical device reassessment process is an essential tool to guarantee the safety, efficacy, and quality of products used in the Brazilian healthcare system. Although it represents a challenge for companies, the reassessment significantly contributes to the protection of public health and the strengthening of the national regulatory system.  For international companies that wish to keep their products on the Brazilian market, a thorough understanding of the reassessment process and preparedness to meet ANVISA’s requirements are fundamental for long-term success.  For more information about the medical device reassessment process, please contact our specialized team, which can offer personalized support for each product category.    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 

Risk assessment constitutes the methodological foundation for the regulation of medical devices globally, with particular relevance in the Brazilian regulatory landscape. This article explores the fundamentals, methodologies, and regulatory implications of risk assessment, with a specific focus on the normative context of ANVISA and its correlations with international standards.  Methodological Fundamentals of Risk Assessment  ISO 14971 defines risk assessment as the “systematic process of identifying hazards and estimating the associated risks.” In the context of medical devices, this process is fundamentally quantitative and qualitative, incorporating:     The risk matrix used in the evaluation of medical devices typically incorporates three main variables:  Brazilian Regulatory System and Risk Classification  ANVISA’s Normative Structure  ANVISA implements a risk-based classification system through specific normative instruments, notably RDC 751/2022, which establishes the minimum requirements for:     Technical Classification Criteria  The Brazilian system adopts a four-risk class approach with specific technical criteria:     CLASS  RISK LEVEL  PRIMARY TECHNICAL CRITERIA  EXAMPLES  I  Low  Non-invasive; temporary contact; non-critical systems  Stethoscopes, stretchers  II  Medium  Transient invasive; connected to a power source or not; monitoring  Infusion pumps, peripheral catheters  III  High  Long-term invasive; vital support; non-critical implantable  Joint prostheses, non-medicated stents  IV  Maximum  Critical implantable; combination with drugs; emerging technologies  Heart valves, drug-eluting stents  This classification structure has a direct correlation with international systems, such as the FDA (Classes I, II, III) and the European system (Classes I, IIa, IIb, III), facilitating regulatory harmonization.  Impact of Risk Assessment on the Regulatory Process  The classification resulting from the risk assessment directly determines:  Risk Assessment Methodology  The process generally follows these steps:  The Importance of MDSAP and Harmonized Approaches  MDSAP represents a significant advancement in regulatory harmonization, allowing a single audit to satisfy the requirements of multiple jurisdictions, including:  The technical implementation of MDSAP involves:  Technical Implications for Manufacturers  Integrating with MDSAP requires specific technical adaptations:  Conclusion  Risk assessment is not just a regulatory requirement but an essential component to ensure the safety and efficacy of medical devices.     In the Brazilian context, a deep understanding of the technical methodologies of risk assessment and their proper application represents a critical factor for regulatory success.  Manufacturers who adequately understand and implement this process not only facilitate regulatory approval but also ensure safer devices for patients.  For international medical device companies seeking access to the Brazilian market, the implementation of risk assessment strategies aligned with ANVISA’s expectations, with particular attention to the specifics of RDC 751/2022 and harmonization via MDSAP, constitutes a differentiating element for regulatory efficiency. Relying on specialized consulting in medical regulation can be crucial to navigate ANVISA’s complex risk assessment system.  Turn regulatory challenges into business opportunities with the expertise your company deserves.    Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

Brazil’s National Health Surveillance Agency (ANVISA) has recently announced an important change in the risk classification of the ultrasensitive CRP (C-reactive protein) parameter, which has been downgraded from class III to class II. This regulatory change represents a significant advancement for manufacturers and importers of in vitro diagnostic (IVD) medical devices in Brazil.  What Has Changed?  According to Technical Note 17/2025/SEI/GEVIT/GGTPS/DIRE3/ANVISA, the reclassification of the ultrasensitive CRP parameter results in a simplification of the regulatory process, as class II devices are subject to a notification regime, which is less complex than the registration required for class III devices.  This measure aligns with Collegiate Board Resolution (RDC) 830/2023, which regulates the notification and registration of in vitro diagnostic medical devices in Brazil. RDC 830/2023, which came into effect in June 2024, brought a series of updates to risk classification rules, seeking harmonization with international standards and an approach based on the actual risk of products.  Impact for the Sector  The reclassification of ultrasensitive CRP to class II represents an important advancement for the in vitro diagnostic sector in Brazil, mainly due to:  What is Ultrasensitive CRP?  Ultrasensitive CRP is a laboratory test that measures extremely low levels of C-reactive protein in the blood, a protein produced by the liver in response to inflammatory processes. Unlike conventional CRP, the ultrasensitive test can detect much lower concentrations, making it particularly useful for assessing cardiovascular risk and monitoring low-grade inflammation.  This test is widely used in clinical practice for:  Deadlines and Guidance for Compliance  Companies that have already filed applications for sanitary reclassification will be contacted directly by the Management of In Vitro Diagnostic Products (GEVIT) for guidance on alternative courses of action. The same procedure will be adopted for registrations (class III) filed or granted during the validity of RDC 830/2023.  It is important to note that the deadline for sanitary reclassification set forth in RDC 830/2023 has not yet ended, extending until June 2, 2025. This provides companies with sufficient time to adapt to the new rules.  Regulatory Context  The reclassification of ultrasensitive CRP is part of a broader movement to modernize the Brazilian regulatory framework for medical devices. RDC 830/2023, which replaced the former RDC 36/2015, seeks to harmonize Brazilian regulation with international best practices, such as the European Regulation for In Vitro Diagnostic Medical Devices (IVDR, 2017/746) and the guidelines of the International Medical Device Regulators Forum (IMDRF).  This regulatory evolution reflects ANVISA’s commitment to establishing a more efficient and risk-proportional regulatory environment, favoring innovation and access to diagnostic   technologies without compromising the safety and efficacy of products available in the Brazilian market.  Conclusion  The reclassification of the ultrasensitive CRP parameter to class II represents a positive measure that simplifies the regulatory process for manufacturers and importers, potentially expanding access to this important diagnostic tool in Brazil. Companies in the sector should be attentive to ANVISA’s deadlines and guidelines to ensure a smooth transition to the new sanitary framework.  For companies that need regulatory support in this transition process, having specialized consulting can be essential to successfully navigate this evolving regulatory landscape.  Our team specialized in regulatory affairs is available to support your company in this transition.  This article was prepared based on official information provided by ANVISA. For more details, we recommend consulting Technical Note 17/2025/SEI/GEVIT/GGTPS/DIRE3/ANVISA and RDC 830/2023 directly.  Link to original news: Guidance on sanitary framework for ultrasensitive CRP parameter — Brazilian Health Regulatory Agency – ANVISA  ANVISA official website: www.gov.br/anvisa    Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

The Evolution of the Regulatory Landscape and Technological Innovations  The global medical device market is in constant transformation, driven by technological advancements and changes in regulatory requirements. For companies looking to enter or expand their presence in the Brazilian market, understanding these trends is essential for strategic planning and long-term success.  Artificial Intelligence and Software as a Medical Device (SaMD)  One of the most significant trends is the growth of Software as a Medical Device (SaMD). With the advancement of artificial intelligence, machine learning algorithms are being embedded into medical devices for diagnosis, monitoring, and treatment. In Brazil, ANVISA has developed specific regulatory frameworks to evaluate these high-tech products, recognizing their unique characteristics and potential risks. A key update on the regulatory agenda includes the revision of RDC 657/2022 to incorporate AI/ML-based devices.  Companies must pay close attention to the specific requirements for SaMD, including algorithm validation, data security, and robust technical documentation. We have observed increasing alignment among international regulatory agencies, which facilitates simultaneous entry into multiple markets.  Wearable Technologies and Telemedicine  The pandemic accelerated the adoption of wearable devices and telemedicine solutions. These products are revolutionizing remote patient monitoring and the delivery of healthcare at a distance. For medical device companies, this trend presents both opportunities and regulatory challenges.  ANVISA has updated its guidelines to address specific issues related to connectivity, data security, and interoperability. Companies seeking to market such products in Brazil must consider aspects such as:  Personalized Medicine and 3D Printing  3D printing is transforming medical device manufacturing by enabling the creation of customized products for individual patients. This technology is revolutionizing areas such as prosthetics, orthopedic implants, and orthodontic devices.  The regulatory framework for personalized medical devices is evolving, with ANVISA establishing specific requirements to ensure safety and efficacy. Companies working with 3D printing must be prepared to provide:  Focus on Sustainability  Sustainability is becoming a critical factor in the development of medical devices. Patients, healthcare professionals, and regulatory bodies are increasingly aware of the environmental impact of these products.  Companies that adopt sustainable practices in the production, packaging, and disposal of medical devices will gain a competitive edge in the Brazilian market. Reducing medical waste and using biodegradable materials are trends expected to gain further traction in the coming years.  International Regulatory Harmonization  The Medical Device Single Audit Program (MDSAP) continues to expand its influence, allowing manufacturers to undergo a single audit to meet the requirements of multiple jurisdictions, including Brazil. This trend toward harmonization facilitates global market access and reduces operational costs.  Manufacturers aiming to enter the Brazilian market can benefit from participating in MDSAP and adopting international standards such as those defined by the Medical Products Agency and other regulatory authorities.  Furthermore, regulatory agencies are increasingly incorporating reliance mechanisms into their regulations, leveraging prior assessments by equivalent regulatory bodies for registration evaluations. This optimizes review timelines and enables faster patient access to medical devices. ANVISA has adopted reliance through Normative Instruction No. 290/2024.  Unique Device Identification (UDI) System  The implementation of the Unique Device Identification (UDI) system is progressing globally, including in Brazil. This system enhances product traceability, post-market surveillance, and product recalls when necessary.  Companies must invest in UDI-compliant systems and appropriate identification software to meet Brazilian regulatory requirements and streamline global product management.  The Future of Medical Device Regulation in Brazil  Brazil’s regulatory landscape for medical devices continues to evolve, with ANVISA implementing new resolutions aimed at both protecting public health and promoting innovation. Key developments include:  The Hospitalar 2024 trade fair showcased the Brazilian medical device market’s rapid growth, highlighting significant opportunities for international companies. However, navigating the regulatory environment requires expert knowledge and strategic planning.  Conclusion  Medical device companies seeking success in the Brazilian market must stay attuned to emerging trends and adapt their regulatory and commercial strategies accordingly. Understanding the specific requirements of the Brazilian market—including those imposed by ANVISA—is essential for successfully navigating the registration and commercialization process.  Staying informed through newsletters and seeking guidance from specialized medical device consultants can make the difference between success and failure in market entry.  For international companies, establishing a reliable ANVISA liaison and understanding INMETRO (for active medical devices) and ANATEL (for telecom-enabled devices) requirements are key steps toward successful market entry.  Facing Challenges Entering the Brazilian Medical Device Market?  If you’re a CEO or executive of a medical device company looking to expand into Brazil, regulatory complexity doesn’t have to be a barrier to your growth. Our expert consultants at Brisa are ready to guide your company through every step of the process.  Contact us today for a personalized assessment of your products and a tailor-made regulatory strategy for the Brazilian market.    Find out more about BPO in RA!  Turn regulatory challenges into business opportunities with the expertise your company deserves.  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

Regulatory compliance has become a fundamental pillar in the medical device industry, profoundly influencing how companies design, develop, and launch their products into the market. Understanding these impacts is crucial for manufacturers seeking to navigate the complex regulatory landscape in Brazil and globally.  The Fundamental Role of Regulatory Compliance  Medical device manufacturers face a challenging balance: creating innovative products while ensuring strict adherence to regulations that safeguard patient safety. In Brazil, the regulatory framework overseen by ANVISA establishes comprehensive requirements that manufacturers must follow throughout the entire product lifecycle.  Implementing Good Manufacturing Practices (GMP)  Good Manufacturing Practices (GMP) serve as the foundation for quality assurance in the production of medical devices. These practices ensure that devices are consistently produced and controlled according to quality standards 1 appropriate for their intended use. For organizations developing medical devices in Brazil, implementing robust GMP systems is not just a regulatory requirement but a competitive necessity.     The implementation of GMP in medical device manufacturing involves:  Companies that successfully integrate GMP principles into their operations typically observe:  For international manufacturers entering the Brazilian market, understanding ANVISA’s specific GMP requirements is essential. ANVISA conducts regular inspections to verify compliance, and failure to meet these standards can result in market access restrictions.  How Compliance Shapes Design and Development Processes  Design Controls and Documentation  Regulatory compliance mandates structured processes with comprehensive documentation at every stage. This includes:  The documentation burden may seem excessive, but structured design controls have been shown to reduce development costs when implemented properly, primarily by identifying issues earlier in the process when they are less expensive to fix.  Integrating Risk Management  Modern regulatory frameworks require risk management to be integrated into all aspects of product development. This integration ensures that potential hazards are identified early and mitigated effectively. For manufacturers, this means:  RDC 751/2022 in Brazil emphasizes risk-based approaches, aligning Brazilian regulations with international standards such as ISO 14971:2019. This resolution requires manufacturers to:  Companies that effectively implement risk management typically identify more potential hazards before market release compared to those using less structured approaches, resulting in safer products and fewer recalls or field actions.  Software as a Medical Device (SaMD)  The rise of Software as a Medical Device (SaMD) presents unique regulatory challenges. These products must meet specific requirements that address their distinctive characteristics.  Regulatory Framework for SaMD in Brazil  ANVISA has aligned its approach to SaMD with international standards, particularly the IMDRF (International Medical Device Regulators Forum) framework. Under Brazilian regulations, SaMD is classified based on:  This classification determines the level of regulatory scrutiny applied to the software.  Key Compliance Requirements for Medical Software  For companies developing standalone software or other medical software applications, specific technical documentation requirements include:  Statistics show that regulatory issues account for 45-50% of delays in SaMD approvals, making regulatory strategy a critical component of development planning for these products.  Impact on Innovation and Time-to-Market  Regulatory compliance undeniably affects development timelines and resource allocation. Companies must consider these factors in their product development strategies.  Quantifying the Regulatory Impact  While these factors can extend development timelines, they also ensure that products entering the market are safer and more reliable. Research indicates that devices developed under robust regulatory frameworks have fewer safety-related recalls compared to those developed under less stringent systems.  Strategies to Minimize Regulatory Delays  Forward-thinking companies are implementing various approaches to reduce the regulatory impact on innovation:  These strategies can reduce regulatory approval times and significantly increase first-time approval rates.  Market Access Considerations  Regulatory compliance directly impacts market access strategies. For medical device manufacturers targeting Brazil, understanding the regulatory pathways is essential for successful market entry.  ANVISA Registration Pathways  ANVISA offers several registration pathways depending on the device’s risk classification:  The typical timeline for ANVISA approvals ranges from:  The Medical Device Single Audit Program (MDSAP)  The Medical Device Single Audit Program (MDSAP) offers a streamlined approach, allowing manufacturers to undergo a single audit to satisfy the requirements of multiple regulatory jurisdictions.  For manufacturers, participation in MDSAP offers several advantages:  ANVISA was an early adopter of MDSAP and now accepts MDSAP audit reports in lieu of ANVISA GMP inspections for foreign manufacturers. This approach has reduced GMP certification times from an average of 18-24 months to 6-12 months for MDSAP participants.  Key requirements for MDSAP participation include:  The Role of Regulatory Consultants  Given the complexity of the regulatory landscape, many companies partner with specialized medical device consulting firms. These experts provide:  For international companies looking to enter the Brazilian market, local regulatory expertise is particularly valuable for navigating ANVISA’s specific requirements. Studies show that companies utilizing specialized regulatory consultants experience:  When selecting a regulatory consultant for the Brazilian market, manufacturers should look for:  Laboratory Developed Tests: A Special Case  Laboratory Developed Tests (LDTs) represent a unique category of medical devices with specific regulatory considerations. In Brazil, ANVISA has established particular frameworks for these products, which include:  Manufacturers developing these products must understand the distinct regulatory pathways that apply to them, which may differ from those applicable to traditional medical devices. Key considerations include:  Recent data indicates that the global market for LDTs is growing annually, with particular growth in molecular diagnostics and companion diagnostics.  Looking to the Future: Evolving Regulatory Landscapes  The regulatory environment continues to evolve, with agencies like ANVISA, the FDA, and other major agencies regularly updating their requirements. Manufacturers must stay informed of these changes through resources such as industry newsletters and regular updates from agency websites and legislation.  Key Regulatory Trends to Monitor  Companies that proactively monitor these trends can better position themselves for future regulatory changes, reducing compliance costs and accelerating time-to-market for new innovations.  Conclusion  Regulatory compliance profoundly shapes medical device development, influencing everything from initial design concepts to market entry strategies. While compliance requirements can present challenges, they ultimately serve to enhance product safety and effectiveness.  For manufacturers, adopting a proactive approach to regulatory compliance—integrating it into development processes rather than treating it as an afterthought—is the most effective strategy for successful product development and commercialization.  By understanding and embracing regulatory

Clinical studies are a crucial step in the medical device development and approval process, ensuring their safety and efficacy before market entry. In this article, we will explore fundamental strategies for planning and executing successful clinical studies for medical devices, particularly within the Brazilian regulatory context.     Understanding the Regulatory Framework  Before initiating clinical study planning, it is essential to understand the current regulatory requirements. In Brazil, the Medical Device Authority responsible for regulating these products is ANVISA (Agência Nacional de Vigilância Sanitária – National Health Surveillance Agency).     The main current regulations governing clinical studies for medical devices include:  Understanding these updated RDCs (Resolutions of the Collegiate Board of Directors) is fundamental for compliance and successful study execution.     Planning Your Clinical Study  1. Define Clear Objectives  Establish specific and measurable objectives for your clinical study:  *Predicate devices refer to legally marketed devices with similar intended use and technological characteristics that serve as a basis for comparison when demonstrating substantial equivalence for a new device. This concept helps streamline the approval process by showing that your new device is as safe and effective as similar devices already on the market.     2. Select the Appropriate Study Design  Choose a study design that best suits your device and objectives:  For Software as a Medical Device (SaMD) products, special considerations may apply regarding validation methodologies.  3. Calculate Appropriate Sample Size  Determine the adequate sample size to achieve statistical significance while balancing resources:  Implementation Strategies  1. Choose the Right Research Partners  Select clinical centers and investigators carefully:  2. Develop Comprehensive Documentation  Prepare complete documentation including:  3. Implement Robust Data Management  Establish reliable data collection and management systems:  Navigating Brazilian Regulatory Requirements  1. Ethics Committee Approvals  Obtain the necessary ethical approvals:  2. ANVISA Submission Process  Prepare for submission to ANVISA headquarters:  Strategies for Increasing Efficiency  1. Risk-Based Monitoring  Implement risk-based monitoring approaches:  2. Leverage Technology  Utilize technological solutions to enhance efficiency:  3. Plan Regulatory Interactions  Schedule strategic interactions with ANVISA:  Post-Study Considerations  1. Comprehensive Data Analysis  Ensure thorough analysis of study results:  2. Reporting and Publication  Develop a strategic plan for reporting and publication:  3. Integration with Registration Strategy  Connect study results with your overall registration strategy:  Conclusion  Conducting efficient clinical studies for medical devices requires careful planning, a thorough understanding of current regulatory requirements, and strategic implementation. By focusing on these key areas, manufacturers can generate high-quality evidence to support their regulatory submissions, optimizing resources and timelines.     For companies seeking to enter the Brazilian market, working with experienced regulatory consultants specializing in medical device consulting can provide valuable guidance through this complex process. Stay informed about regulatory changes through reliable sources such as the Brazilian MD market by Brisa and maintain open communication channels with ANVISA throughout the development and study process.     For expert guidance on navigating these complex regulatory requirements, contact our medical device consulting team to ensure your innovative products meet all necessary compliance standards while maintaining your competitive edge in the 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