Brazil’s healthcare sector is entering a new era, one defined by digital transformation, medical technology, and intelligent systems that are reshaping the way care is delivered. From remote monitoring to surgical robotics and AI-driven diagnostics, innovation is no longer an abstract concept; it’s a daily reality in hospitals, clinics, and homes across the country. But innovation in healthcare can only thrive when it’s supported by robust regulation. That’s where the balance lies: enabling technological progress while protecting patients and ensuring safety, quality, and trust. At Brisa, we believe that regulation and innovation are not opposites, they are partners in progress. 1. A Market Ready for Innovation Brazil stands out as Latin America’s largest and most dynamic medical device market. With a population of over 200 million and one of the world’s most extensive public healthcare systems (SUS), the country presents both scale and diversity for new technologies. The growing demand for advanced diagnostics, connected care, and minimally invasive treatments is pushing hospitals and clinics to adopt smarter, data-driven solutions. At the same time, Anvisa’s modernization and alignment with international standards have created a more predictable environment for technology adoption. This combination of market demand plus regulatory maturity has turned Brazil into one of the most promising frontiers for medtech innovation. 2. Emerging Technologies Reshaping Care Some of the most transformative technologies now entering Brazil include: 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 Health Regulatory Agency ANVISA has issued Normative Instruction No. 426, dated February 13, 2026, establishing the requirements for data submission and management within the Unique Device Identification System SIUD. This regulation complements RDC No. 591/2021, strengthening the framework for medical device traceability in Brazil.  Key highlights of IN ANVISA 426/2026:  Why it matters: The publication of IN 426/2026 marks a milestone in the implementation of Brazil’s UDI system, aligning the country with international best practices in medical device traceability. The regulation enhances patient safety, strengthens post-market surveillance, improves regulatory processes, and increases the global competitiveness of the Brazilian medical device industry.  In summary, this normative instruction brings regulatory predictability, promotes data transparency, and reinforces the integration of all stakeholders in Brazil’s medical device 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 

The healthcare industry is experiencing a data revolution and regulatory affairs are no exception. In a sector defined by complexity, precision, and constant change, data and analytics have become essential tools for making faster, more accurate, and more strategic decisions.  For medical device manufacturers and distributors, the ability to analyze regulatory trends, performance indicators, and compliance metrics is now a key competitive differentiator. At Brisa, we see data not just as information, but as intelligence that guides the future of regulatory strategy.  1. Why Data Matters in Regulatory Affairs  Every regulatory process generates vast amounts of data, from dossier submissions and clinical evaluations to post-market reports and inspection records. Traditionally, this information has been handled manually, stored in silos, and used reactively.  Modern data analytics transforms that reality by allowing companies to:  This shift moves regulatory management from an operational task to a strategic intelligence function, where decisions are supported by objective evidence rather than assumptions.  2. Predictive Intelligence: Anticipating Change  Regulatory environments, particularly in Brazil, evolve continuously. Anvisa’s updates, new RDCs, and shifts in international harmonization policies can impact manufacturers’ market access strategies.  Through predictive analytics, companies can anticipate these movements by:  This approach allows organizations to stay ahead of change, adapt documentation proactively, and maintain a state of readiness, a crucial advantage in markets where time-to-approval directly affects competitiveness.  3. Data-Driven Post-Market Surveillance  After a product is approved, continuous monitoring becomes the next challenge. Data-driven post-market surveillance enables companies to detect safety signals, analyze field performance, and manage adverse event reports efficiently and transparently.  Brisa supports clients in establishing integrated systems that connect regulatory records, logistics data, and customer feedback. This integration ensures compliance with Anvisa’s vigilance requirements while reinforcing the manufacturer’s commitment to product quality and patient safety.  4. The Brisa Approach: Intelligence at the Core of Compliance  At Brisa, we combine regulatory expertise with data intelligence to transform compliance into a strategic advantage. Our approach integrates analytics into every stage of the regulatory journey:  This holistic model gives our clients full visibility and control over their regulatory operations, enabling smarter, faster, and more confident decision-making.  5. Conclusion: From Data to Strategy  The future of regulatory affairs belongs to organizations that turn data into foresight. In a world where information is abundant but time is limited, analytics provides the clarity needed to make decisions that are both compliant and competitive.  At Brisa, we believe that the true power of data lies in transforming regulatory management into strategic intelligence, bridging the gap between compliance and innovation.  Because in modern healthcare, insight is the new advantage.  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 

Entering the Brazilian healthcare market represents a powerful opportunity, but also a unique challenge. As one of the largest and most regulated medical device markets in the world, Brazil combines high growth potential with a complex regulatory, fiscal, and logistical environment.  For global manufacturers, the difference between success and delay often lies in finding a local partner who understands not only Anvisa’s regulatory framework, but also the commercial and operational realities of doing business in Brazil.  At Brisa, we bridge that gap. Through an integrated and strategic approach, we help international manufacturers move from regulatory approval to full market access: safely, efficiently, and with total transparency.  1. Understanding the Brazilian Landscape  Brazil accounts for nearly 40% of Latin America’s medical device market, making it an essential destination for manufacturers seeking regional expansion. However, its complexity (with a detailed regulatory process, layered taxation, and regionalized distribution) demands a structured and localized strategy.  Every successful market entry in Brazil depends on four pillars:  Brisa’s integrated ecosystem was designed to unify these pillars under one structure, minimizing risks and maximizing predictability.  2. Regulatory Consulting: Building a Strong Foundation  Regulation is the foundation of any market entry strategy. Our team of specialists provides comprehensive regulatory consulting, guiding clients through every step of the Anvisa process: from product classification and dossier preparation to registration and post-market obligations.  We also help manufacturers anticipate changes by monitoring regulatory updates and aligning their documentation with Anvisa’s evolving requirements. This proactive approach reduces approval timelines and strengthens long-term compliance.  3. Legal Representation: Acting as Your Trusted Partner in Brazil  For foreign manufacturers, it is mandatory to have a legal representative established in Brazil, an entity responsible for interacting with Anvisa and ensuring ongoing compliance. At Brisa, we assume this role with full accountability, managing the manufacturer’s regulatory portfolio and guaranteeing alignment with all local obligations.  Our governance model ensures transparency in every process, providing clients with real-time visibility of documentation, renewals, and regulatory milestones.  By acting as both representative and strategic advisor, we enable manufacturers to operate confidently in the Brazilian market.  4. Importation and Logistics: Turning Strategy into Operation  Once the product is approved, success depends on how efficiently it reaches the market. Brazil’s tax and customs landscape can be intricate, involving multiple authorities and state-level regulations.  Brisa manages the entire importation and logistics process, combining fiscal planning, warehousing, and distribution oversight to ensure compliance and efficiency.   We integrate regulatory and operational data into a single system, enabling faster clearance, accurate tracking, and full traceability.  This approach transforms potential bottlenecks into competitive advantages.  5. Commercial Integration: Connecting Innovation to the Market  Our role does not end with importation; we help manufacturers connect with the healthcare ecosystem. Through our strategic distribution network, Brisa facilitates market reach, connecting products with private hospitals, purchasing groups, and institutional buyers.  By aligning regulatory compliance with commercial execution, we help ensure that innovation not only enters the country but also reaches the patients who need it most.  6. Conclusion: From Entry to Expansion  Market entry into Brazil is a journey that demands expertise, foresight, and partnership. At Brisa, we combine all three.  By integrating regulatory consulting, legal representation, importation, and distribution under one ecosystem, we simplify the path for global manufacturers, transforming complexity into clarity and approval into access.  Because in Brazil, success belongs to those who understand that market access is more than registration: it’s strategy.  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