For every medical device entering the Brazilian market, classification is the first and most critical regulatory step. This process determines not only how the device will be evaluated by Anvisa (Brazil’s National Health Surveillance Agency) but also the scope, cost, and timeline of its approval.  In other words, accurate classification is the foundation of an efficient regulatory strategy. Misclassification, on the other hand, can lead to delays, noncompliance, or even market withdrawal.  The Logic Behind Classification  Anvisa’s classification framework follows international standards harmonized with the International Medical Device Regulators Forum (IMDRF). It is based on the principle of risk management: the higher the potential risk to the patient or user, the stricter the regulatory requirements.  Each device is classified into one of four risk classes:  This classification defines whether the device will go through a notification (cadastro) or a registration (registro) process, as well as whether Good Manufacturing Practice (CBPF) certification will be required.  Key Criteria Considered by Anvisa  When determining the risk class, Anvisa evaluates a combination of technical and clinical factors, including:  These parameters must be carefully documented and justified in the technical dossier. A well-structured rationale can make the difference between a smooth submission and one that requires multiple rounds of clarification.  Why Proper Classification Is Strategic  Correct classification goes beyond regulatory compliance; it is a strategic decision. It directly influences:  By defining the right path early, manufacturers can plan production, importation, and commercialization with far greater predictability.  Brisa’s Expertise in Classification and Regulatory Strategy  At Brisa, we support manufacturers and distributors in accurately classifying their products and designing the most efficient regulatory pathway for entry into Brazil. Our team analyzes each device from a technical, legal, and clinical perspective, ensuring full alignment with Anvisa’s expectations and IMDRF standards.  Through our integrated regulatory ecosystem, we combine classification, registration, importation, and commercialization under a unified strategy, enabling our clients to bring innovation to the market safely and efficiently.  Conclusion: Every Successful Approval Starts with the Right Classification  In a market as dynamic and demanding as healthcare, success begins with precision. A clear understanding of classification not only ensures compliance but also accelerates innovation, protects patients, and strengthens trust.  At Brisa, we help global manufacturers navigate this first and most decisive step because every successful regulatory journey starts with the right classification.  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 highly regulated healthcare environment, making decisions without updated data and strategic analysis is a risk no company can afford.That’s why regulatory intelligence has become a fundamental pillar for any organization operating in the medical device market, especially in Brazil, where the regulatory framework is complex, detailed, and constantly evolving. More than just following Anvisa’s publications, regulatory intelligence means anticipating scenarios, interpreting trends, and turning information into strategy. What Is Regulatory Intelligence Regulatory intelligence is the systematic process of collecting, analyzing, and applying information related to regulatory frameworks, public policies, technical standards, and market practices. Its purpose is to predict risks, identify opportunities, and support decision-making based on concrete data. In practice, this means continuously monitoring: Updates from Anvisa and other health authorities;Changes in resolutions and normative instructions (RDCs and INs);International harmonization movements (IMDRF, WHO, PAHO);Market trends that may affect the approval, importation, or commercialization of medical products. Why Regulatory Intelligence Is Strategic Companies that apply regulatory intelligence gain both agility and security.Instead of reacting to changes, they anticipate them, adjusting their products, documentation, and internal processes proactively. The key benefits include: Risk reduction, preventing delays, sanctions, and rework;Operational efficiency, focusing resources on what truly matters;Faster approvals, adapting early to new requirements;Competitiveness, turning compliance into a market advantage. In complex markets such as Brazil, where regulations are detailed and frequently updated, regulatory intelligence is what separates companies that merely operate from those that lead with strategy. Brisa’s Role in Regulatory Intelligence At Brisa, regulatory intelligence is at the core of our approach.We continuously monitor regulatory updates, public consultations, and international trends to translate information into strategic direction for our clients. Our specialists combine technical analysis, legal knowledge, and business insight to develop customized regulatory plans that align innovation, compliance, and commercial viability. This integrated approach enables manufacturers and distributors to make informed, predictable decisions in a challenging regulatory environment. Conclusion: Data, Strategy, and Regulation Move Together In a sector undergoing constant transformation, information is the most valuable asset for sustainable growth.Regulatory intelligence is not just a monitoring tool, it is a competitive advantage capable of transforming regulation into a driver of growth. At Brisa, we believe that anticipating regulatory change is just as important as innovating in technology, and that is why regulatory intelligence stands at the heart of our ecosystem. 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 medical device industry, no one grows alone.  Regulatory complexity, tax burden, and logistical challenges make it essential to establish strategic partnerships among manufacturers, distributors, consultancies, and local operators.  More than a trend, this integration has become a key driver of competitiveness and sustainability.  At Brisa, we believe that strong partnerships are the link connecting innovation, regulation, and access.  An industry that depends on synergy  The healthcare sector is made up of an extensive chain, from technology development to clinical use, and every link must operate in synergy to ensure safety and efficiency.  Manufacturers, distributors, and service providers work in a highly regulated environment, and collaboration among them is what ensures that innovation reaches the market sustainably.  Strategic partnerships make it possible to eliminate redundancies, optimize processes, and share regulatory intelligence, leading to greater predictability and reduced costs.  Partnerships that expand access and reduce barriers  For international manufacturers, Brazil represents a promising but technically demanding market.  In this context, partnering with specialized consultancies and experienced local operators is the most effective way to overcome entry barriers and ensure compliance with Anvisa’s requirements.  An experienced partner provides not only operational support, but also strategic insight into taxation, logistics, regulation, and market positioning.  When well structured, such collaboration transforms regulatory challenges into a true competitive advantage, especially in the context of MDSAP and GMP good practices.  Integration and transparency as pillars  The ideal partnership model is built on integration and transparency.  Each participant understands its role in the product lifecycle and acts with a shared commitment to sustainable results.  At Brisa, we work through a collaborative approach, connecting manufacturers, distributors, and purchasing groups within an integrated regulatory ecosystem that enables data sharing, timeline optimization, and coordinated market access strategies.  This model is especially relevant for companies seeking FDA registration and needing to navigate simultaneously through Brazilian and North American regulatory systems.  The Brisa ecosystem as a model of collaboration  The Brisa ecosystem was designed to bring together all players in the healthcare chain around a common goal: facilitating access to innovative medical technologies in Brazil.  Our model combines:  Specialized regulatory consulting: ensuring the safe and efficient entry of products, including support for medical device consulting and compliance with Anvisa standards.  Importation and legal representation: with optimized fiscal and logistical structures, facilitating contact Anvisa and processes with authorities such as the Medical Device Authority and Health Sciences Authority.  A strategic distribution network: linking manufacturers to regional buyers and healthcare institutions.  Comprehensive governance and traceability: ensuring compliance at every stage, including UDI requirements and product identification systems.  This collaborative format reduces costs, shortens timelines, and expands access to essential medical technologies, benefiting manufacturers, distributors, and Brazil’s healthcare system as a whole.  Conclusion: collaboration as a driver of innovation  Today, healthcare innovation depends not only on technology, but on the quality of the partnerships that support it.  Building strategic alliances based on trust, transparency, and shared objectives is what turns projects into measurable results.  At Brisa, we believe the future of healthcare is collaborative, integrated, and sustainable, which is why partnerships are at the heart of our ecosystem.  For companies seeking to better understand the Brazilian regulatory framework and optimize their market entry strategies, having partners who master everything from RDCs to international requirements of Health Products Regulatory Authority and Medical Products Agency makes all the difference.  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 

Bringing a medical technology into Brazil involves much more than logistics and commercialization.Behind every device lies a complex and essential regulatory chain, designed to ensure that products reach healthcare professionals, and ultimately patients, with safety, effectiveness, and full traceability. This journey, which begins with the manufacturer and ends at the clinical application, is carefully structured and supervised by Anvisa, Brazil’s National Health Surveillance Agency. Understanding each stage of this process is the first step toward operating successfully and sustainably in the Brazilian market. The regulatory journey begins at the product development stage, often in the country of origin.At this point, manufacturers perform performance tests, safety validations, and clinical evaluations (when applicable) to demonstrate compliance with international standards such as ISO 13485 and IMDRF guidelines.These documents form the foundation of the regulatory dossier that will later be submitted to Anvisa.The stronger this technical foundation, the more predictable and efficient the approval process becomes. To apply for registration, the manufacturer must appoint a legal representative in Brazil, responsible for managing the process with Anvisa and maintaining post-approval compliance.This representative acts as the key communication link between the manufacturer, the regulatory authorities, and local stakeholders. At Brisa, this function is embedded within an integrated ecosystem that combines legal representation, importation, and regulatory intelligence by giving manufacturers full governance and transparency over their products. The first official step in the regulatory process is the risk classification of the medical device, in accordance with RDC 751/2022.Based on this classification, the product will follow one of two regulatory pathways: Notification – for Class I and II devices, considered low or medium risk. This streamlined process focuses on documentary evidence, labeling, and quality system certification. Registration – for Class III and IV devices, considered high or maximum risk. This pathway requires a comprehensive technical dossier, including clinical data (when applicable), risk analysis, and proof of Good Manufacturing Practice (GMP) certification. Upon approval, the product receives a unique registration number, authorizing its importation, distribution, and commercialization throughout Brazil. Once registered, each product must undergo import authorization and sanitary clearance through Anvisa and the Brazilian Federal Revenue Service.This stage ensures that every imported batch maintains full traceability, integrity, and compliance with the approved regulatory conditions. Here, the integration between regulatory consulting and logistics operations becomes crucial and represents one of Brisa’s core differentiators. After clearance, the product enters the distribution phase, governed by RDC 665/2022, which establishes strict requirements for storage, transportation, and traceability.Every unit must be traceable back to its origin, ensuring that any nonconformity can be rapidly identified and resolved. Organizations that manage this phase efficiently deliver not only compliance but also market credibility and patient safety. The final stage of the journey occurs in the clinical setting, where the device is used by healthcare professionals.Even after market entry, regulatory obligations continue: the registration holder must monitor adverse events, handle technical complaints, and periodically update product documentation. This ongoing surveillance ensures that the device maintains its safety and performance throughout its entire lifecycle. A Journey that Demands Strategy Each stage of the regulatory process, from design to clinical use, requires planning, technical expertise, and integrated management.Companies that view regulation as part of their innovation strategy can reduce time to market, optimize costs, and accelerate patient access to new technologies. At Brisa, we’ve structured our regulatory ecosystem to accompany this complete journey, ensuring that every product moves from manufacturer to patient with efficiency, compliance, and trust. 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 

New regulatory roadmap defines 161 priority themes for medical devices, pharmaceuticals, and health products  Key Highlights  The Brazilian Health Regulatory Agency (Anvisa Brasília) approved its Regulatory Agenda for 2026-2027 on December 10, 2024, establishing a comprehensive framework of 161 priority regulatory themes for the next two years.  Agenda Composition  Priority Distribution  Unprecedented Public Participation  The consultation process achieved record engagement:  Impact on Medical Device Sector  Companies engaged in medical device consulting should prepare for regulatory updates in:  Post-market surveillance enhancement  Implementation Timeline  Formal publication: Decree in Diário Oficial da União   Effective date: January 1, 2026  Monitoring tools: Daily and quarterly tracking panels available  Strategic Recommendations  Organizations should:  Conclusion  The 2026-2027 Regulatory Agenda represents a significant milestone for Brazilian healthcare regulation. With strong emphasis on medical devices, pharmaceuticals, and cross-sector harmonization, companies must begin strategic planning now to ensure compliance readiness by January 2026.  The unprecedented level of public participation  647 submissions generating over 2,000 manifestations  demonstrates the maturity of Brazil’s regulatory system and the importance of stakeholder engagement in shaping health policy.  Note: The complete translated list of themes is available at Anvisa’s official portal. / English Version   This article provides informational guidance and does not replace consultation with qualified regulatory professionals or official regulatory documents.  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, 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