Anvisa, the National Health Surveillance Agency, is the body responsible for regulating, authorizing, and supervising the entry and commercialization of products that impact health in Brazil.  In the case of medical devices, the agency’s role is crucial to ensure that only safe, effective, and quality technologies reach the market.  With a robust technical framework in constant modernization, the Brazilian regulatory system has been consolidating as one of the most structured in Latin America, and understanding its dynamics is essential for companies seeking to operate in the healthcare sector.  Classification and Risk Framework  The starting point of any regulatory process at Anvisa is the product framework, that is, the definition of its risk class.  This classification follows internationally harmonized criteria (based on IMDRF and RDC 751/2022), which consider factors such as:  Based on these criteria, medical devices are divided into four classes:  This stage is fundamental, as it defines the type of applicable regulatory process and the set of technical and documentary requirements demanded.  Regulatory Processes: Notification and Registration  After classification, devices follow two distinct paths:  Notification applicable to Class I and II products, of low and moderate risk. The process is simplified, focusing on proof of safety and efficacy through technical documentation, labeling, INMETRO and ANATEL certification (when applicable).  Registration applicable to Class III and IV products, of high and maximum risk. Requires the submission of complete technical dossiers, including validation reports, clinical performance, risk analysis, and proof of compliance.  In both cases, the manufacturer must maintain a legal representative in Brazil, responsible for petitioning and liaison with Anvisa.  Good Manufacturing Practices Certification (CBPF)  For Class III and IV devices, Good Manufacturing Practices Certification (CBPF) is a mandatory requirement.  Issued by Anvisa after an audit of the manufacturer, this certification proves that the company adopts quality systems minimally aligned with RDC 751/2022.  CBPF is one of the most critical stages of the process, as it ensures that the product is manufactured under rigorous quality, safety, and traceability controls.  Modernization and Regulatory Convergence  In recent years, Anvisa has been implementing modernization initiatives that bring Brazil closer to international standards.  Among the main ones are:  These measures reinforce Anvisa’s commitment to efficiency and transparency, without giving up health safety, an essential balance to stimulate innovation.  Post-Market and Registration Maintenance  Regulatory responsibility does not end with approval.  After granting registration or notification, the holder must comply with post-market obligations, such as:  This continuous monitoring ensures that the product remains compliant throughout its entire life cycle in the market.  Conclusion: Regulation as a Foundation for Sustainable Growth  Anvisa’s regulatory system is, above all, an instrument of trust.  For manufacturers who understand it, it becomes a strategic asset, capable of boosting brand credibility and enabling entry into one of the largest healthcare markets in Latin America.  At Brisa, we work to make this process more predictable, efficient, and safe, connecting innovation to regulatory compliance.  Because, in the end, understanding regulation is the first step to expanding solidly 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 

In the healthcare sector, regulation and innovation are not opposing forces, they are complementary. When well-structured, regulation becomes the foundation that allows new technologies to reach the market with safety, predictability, and credibility. The challenge lies in balancing patient protection and innovation incentives, ensuring that rigorous processes do not become barriers but rather bridges for technological development. Regulation as an Instrument of Trust Regulation is what provides safety, transparency, and predictability to the entire healthcare ecosystem. It establishes minimum quality standards, defines responsibilities, and ensures that products, equipment, and medical software are evaluated technically and ethically before reaching patients. In Brazil’s case, Anvisa has made significant progress in this balance. In recent years, the agency has been modernizing its processes, adopting international regulatory convergence practices aligned with the International Medical Device Regulators Forum (IMDRF) recommendations. These initiatives bring the country closer to mature markets such as the European Union and United States, and facilitate mutual recognition of good practices, reducing costs and time for international manufacturers. Regulation That Stimulates Innovation A predictable regulatory environment aligned with global standards attracts investment and local development. Manufacturers tend to prioritize countries with clear rules and digital processes, as this reduces uncertainties and facilitates strategic planning. Innovation depends not only on technology but also on the regulatory environment in which it is applied. When regulation is modern and responsive, it allows the entry of connected devices, artificial intelligence solutions, and software as medical devices (SaMD) in a safe and scalable manner. Brazil has taken important steps in this direction, such as the digitalization of petition and certification processes, encouragement of emerging technology evaluation, and openness to technical dialogue with the productive sector. The Importance of Medical Device Consulting In this scenario, companies working with innovation need partners who understand regulatory complexity and can translate technical requirements into market strategies. This is where Brisa positions itself: as a medical device consulting firm that not only executes regulatory processes but also acts strategically to transform regulation into competitive advantage. Brisa’s accumulated experience with manufacturers, distributors, and regulatory agencies allows for the design of customized solutions, aligned with each technology’s moment and the compliance requirements of the Brazilian market. Innovating with Safety Means Innovating with Regulation The future of healthcare lies in the convergence between technology and regulation. Companies that understand this balance can innovate faster, build credibility, and achieve sustainable results. At Brisa, we believe that innovating with safety means innovating with regulation. Therefore, our commitment is to strengthen this link, so that technological advancement reaches those who truly matter faster: healthcare professionals and 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 

The medical device sector in Brazil faces a scenario of high relevance and natural vocation. There are structural, demographic, and regulatory factors that make the country a strategic target for international manufacturers seeking to expand their operations in Latin America. A Robust and Expanding Market According to Fortune Business Insights consulting firm, Brazil’s medical device market was valued at US$ 15.28 billion in 2024, with projections to grow to US$ 25.00 billion by 2032, corresponding to a CAGR (compound annual growth rate) of 6.4% between 2025 and 2032. This growth is driven by demographic changes (such as population aging and increased chronic diseases), by the growing demand for diagnostics, medical interventions, and more sophisticated health solutions, factors that elevate the demand for medical devices. Furthermore, the national health market combines a broad public structure with a significant private sector. According to recent surveys, the country has approximately 7,309 hospitals, of which about 63% are private. Comprehensive Healthcare System and National Market Role The Unified Health System (SUS) continues to play a central role: according to government data compiled for the international market, SUS is the sole healthcare provider for about 72% of the Brazilian population, that is, for the vast majority of citizens, in this indicator, approximately 164 million people. This degree of coverage and the size of the hospital network create an environment of continuous demand for medical devices, considering use in both public and private hospitals, clinics, diagnostic centers, and laboratories. Moreover, according to a study by the Netherlands Enterprise Agency, via the “Brazil Life Sciences & Health Market Study 2019” report, Brazil is recognized as the main medical device market in Latin America. Why Brazil Represents a Strategic Opportunity for International Manufacturers Demand scale: with thousands of hospitals and broad public health system coverage, there is a large domestic market that absorbs medical devices to meet diverse needs, from large hospitals to smaller clinics and units. Public-private mix: the coexistence between public health (via SUS) and the private sector expands the range of opportunities, both for mass-market devices and cutting-edge technologies. Consistent growth: the projected market from US$ 15.28 billion to US$ 25.00 billion indicates there is room for expansion in the coming years, especially considering technological innovations, population aging, and demands for more sophisticated healthcare. Structured regulatory environment: although regulation (via Anvisa and other agencies) imposes important technical and regulatory requirements, which requires specialized workforce or local partnership, this environment also ensures clarity and predictability for those planning to enter the market with compliance and strategy. Conclusion: Brazil as a Strategic Destination and Gateway For international manufacturers, Brazil is not just another market, it is a strategic hub in Latin America: with favorable demographics, broad health infrastructure, real demand, and multiple channels (private + public). Among risks and regulatory complexity, there is also the advantage of operating in a large, consolidated environment with sustained growth opportunity. For those who understand Brazilian regulation, taxes, logistics, and market particularities, the opportunity to enter the country represents more than sales, it represents real impact on health, access, and innovation. In these cases, relying on specialized medical device consulting or a partner region becomes essential. If you seek to enter Brazil with medical devices, it is worth considering, with caution and strategy, that market conditions are solid and that the investment can be more than justified. 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 Brazilian medical device market is one of the most complex and promising in the world. With a population of over 200 million people, a robust public health system, and a constantly expanding private network, Brazil represents a strategic opportunity for international manufacturers seeking to grow in Latin America.  However, entering this market requires more than just a good product—it demands regulatory understanding, tax planning, reliable partners, and a long-term vision. This is where the Brisa ecosystem emerges.  Beyond Regulatory Consulting  Brisa was born as a consulting firm specialized in regulatory affairs but has evolved to become a true hub of integrated solutions for the healthcare sector.  Today, the Brisa ecosystem operates from the registration and certification of medical devices with Anvisa to the importation, distribution, and commercialization of products within the national territory.  This structure was designed to eliminate historical barriers that hinder foreign manufacturers’ access to the Brazilian market—such as dependence on local distributors, high tax costs, and lack of transparency in processes.  How the Ecosystem Works  The Brisa model is based on four main pillars:  Results That Strengthen the Entire Chain  The impact of this model goes beyond operations.  The Brisa ecosystem generates shared value: manufacturers gain predictability, distributors expand their portfolio safely, and the Brazilian health system gains faster access to innovative medical technologies.  By connecting all links in the chain transparently and efficiently, Brisa contributes to a more sustainable and competitive business environment.  Connecting Innovation, Regulation, and Access  More than simplifying processes, Brisa’s purpose is to build bridges between innovation and regulation, ensuring that life-saving technologies reach healthcare professionals and patients with quality, safety, and speed.  The Brisa ecosystem represents the natural evolution of regulatory consulting: an integrated, modern, and collaborative model that puts Brazil on the global map of health innovation.  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 

In the fast-evolving world of medical devices, efficiency is the bridge that connects innovation to patient care. Every technological advancement (whether diagnostic, therapeutic, or monitoring) only fulfills its purpose when it reaches the healthcare system and, ultimately, the patient who needs it most. Between the development of a technology and its arrival in the Brazilian market lies a complex journey: regulatory approvals, tax barriers, logistical challenges, and hospital integration. This is where Brisa Advisors operates (making the process faster, more predictable, and more sustainable). Efficiency as the Foundation of Market Access In the context of market access, efficiency means much more than speed. It’s about structure, planning, and integration. A medical device only reaches the patient at the right time when every step (regulatory, fiscal, logistical, and commercial) is strategically aligned. At Brisa Advisors, we have built a collaborative market access ecosystem that serves as a single coordination point for international manufacturers. Our model combines technical precision, strategic insight, and solid partnerships with key healthcare stakeholders. The Brisa Advisors Ecosystem Our ecosystem was designed to eliminate barriers and accelerate results. It is structured around four fundamental and interconnected pillars: The result is a coordinated and transparent flow, where each stage reinforces the other (reducing timelines and expanding access to advanced healthcare technologies in Brazil). Efficiency That Creates Real Impact Efficiency is not just an operational advantage (it’s a social responsibility). Every faster approval means a patient treated sooner, a therapy started earlier, a life transformed. That’s why we believe regulatory efficiency and strategic collaboration are the keys to shortening the distance between innovation and the patient. When the process operates in an integrated and coordinated way, everyone benefits: manufacturers reduce costs and risks, healthcare systems gain access to innovation, and patients receive faster, safer care. An Invitation to Collaborate The future of the medical device industry depends on collaborative market access models that combine technical expertise, regulatory intelligence, and a shared commitment to social impact. At Brisa Advisors, we are ready to build that future (with efficiency, transparency, and purpose). Would you like to accelerate your medical device’s access to the Brazilian market? Contact our team and schedule a virtual meeting. Together, we’ll design the right strategy to bring your innovation closer to patients (efficiently and sustainably). Brisa Advisors:  Connecting global innovation to the Brazilian market  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

The global medical device market is undergoing a profound transformation. As new technologies emerge at unprecedented speed  combined with increasingly complex regulatory requirements and healthcare access demands companies must adopt new, integrated, and agile models to stay competitive.  In this context, the concept of market access has evolved. It is no longer just about obtaining regulatory approval or following a traditional import and commercialization path. True market access today depends on integration between regulation, taxation, distribution, and hospital engagement.  This is where the collaborative model becomes essential.   From Linear Processes to an Integrated Ecosystem  Traditionally, the journey to bring a medical device into a new country has been fragmented: one party handles regulatory affairs, another manages customs clearance, and yet another takes care of distribution. This siloed approach creates operational gaps, increases costs, and often delays patient access to technology.  The collaborative model changes that. By connecting from the very beginning regulatory registration, tax planning, logistics, and hospital commercialization, companies can dramatically reduce time to market, increase predictability, and ensure that their products reach patients efficiently and in full compliance.  What emerges is not just a supply chain but an ecosystem.   The Brisa Advisors Ecosystem: Integration That Delivers  At Brisa Advisors, we have developed a comprehensive market access ecosystem that collaborates with key stakeholders across the sector regulators, distributors, hospitals, and international manufacturers.  Our model is built on four strategic pillars:  This integrated approach turns market entry into a coordinated journey, where each stage reinforces the other. The outcome? Faster entry, lower costs, and greater impact on patient outcomes.   Collaboration as a Competitive Advantage  In today’s global landscape, collaboration is no longer a trend it’s a competitive advantage. Manufacturers that embrace collaborative market access models reduce risks, accelerate timelines, and achieve stronger positions in complex markets like Brazil.  Moreover, by aligning every actor in the value chain, companies gain something even more valuable: institutional trust and credibility within the healthcare system.   Brazil as a Strategic Destination  With the market expected to reach USD 25 billion by 2030, Brazil represents one of the most promising opportunities for global medical device manufacturers. But unlocking that potential requires more than ambition it demands planning, structure, and the right partnerships.  Brisa Advisors provides precisely that: a collaborative ecosystem that transforms regulatory challenges into strategic advantages.   Meet Us at MEDICA Fair 2025  We will be attending MEDICA Fair 2025 in Düsseldorf (November 17 20), showcasing our integrated solutions for market access in Brazil. Our executive team already has open slots for meetings before and during the event, and we look forward to discussing customized strategies for your entry and commercialization in the Brazilian market.  Book a meeting with us and discover how the Brisa Advisors ecosystem accelerates innovation bringing your technology closer to the patients who need it most.  Book your meeting: 📅 https://calendly.com/brisa advisors/30min  Brisa Advisors:  Connecting global innovation to the Brazilian market  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

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

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

Strategic Context of the Update  The manual’s update is part of a continuous review process for the Manuals of Registration of Health Use Materials and Equipment, with the main objective of aligning this content with the new regulatory framework in the area. This initiative demonstrates Anvisa’s commitment to maintaining an updated and efficient regulatory environment that addresses both public health needs and the demands of the regulated sector.  Key Regulatory Standards Considered  The new version of the manual incorporates and aligns with three fundamental Collegiate Board Resolutions (RDC):  Content and Structure of the Manual  Strategic Guidance Tool  The new manual is configured as a strategic guidance tool for the regulated sector, offering detailed guidelines on the entire regularization process. The document’s structure was carefully developed to facilitate the understanding and application of regulatory requirements.  Key Topics Covered  Collaborative Development Process  Engagement with the Regulated Sector  One of the highlights of this manual’s update was the collaborative approach adopted by Anvisa. During the document’s elaboration, preliminary versions were shared with representative entities of the sector, including:  This collaborative construction ensured that the manual:  Benefits of the Collaborative Approach  The engagement of representative entities brought several benefits:  Expected Strategic Impacts  Improvement in Petition Quality  One of the main objectives of the new manual is to improve the quality of petitions submitted to Anvisa. This is expected to result in:  Operational Efficiency  The publication of the updated manual contributes to:  Practical Implications for the Sector  For Manufacturers  National and international manufacturers benefit from:  For Legal Representatives  Legal representatives and distributors gain:  For Consultants and Regulatory Professionals  Professionals specialized in medical device consulting can:  Integration with the Broader Regulatory Context  Alignment with International Standards  The manual’s update also aligns with international trends in the regulation of medical devices, including:  Continuous Evolution of the Regulatory Framework  The manual is part of a continuous evolution process of the Brazilian regulatory framework, which includes:  Recommendations for the Regulated Sector  Immediate Actions  Companies operating in the medical device sector should:  Strategic Planning  For the medium and long term, it is recommended to:  For Companies with International Operations  Companies that also operate in other markets should:  Additional Resources and Support  Official Channels  For additional clarifications and updated information:  Professional Support  Companies can seek specialized support through:  Conclusion  The publication of the new version of the Manual for Regularization of Medical Equipment and Software as a Medical Device represents a significant advance in the Brazilian regulatory environment. The initiative demonstrates Anvisa’s commitment to:  For companies operating in the medical device segment, this update represents an opportunity to:  Success in implementing these new guidelines depends on the active engagement of all actors in the sector – from manufacturers to regulatory professionals, including representative entities and Anvisa itself.  Source  This article was prepared for informational purposes and does not replace consultation with the official legislation in force. For more information on regulatory consulting services and BRH solutions, consult qualified specialists in medical device regulation who maintain up-to-date knowledge of ANVISA requirements and Brazilian medical device regulations.  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

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