Why Most Medical Devices Take Too Long to Reach Hospitals in Brazil There’s a moment every manufacturer entering Brazil looks forward to. Regulatory approval’s granted. After months—sometimes longer—the product’s officially authorized. At that point, the expectation’s clear: Now things should move. But then something unexpected happens. They don’t. At least not at the pace most companies anticipate. Weeks go by. Then months. The product’s approved but not widely used. And the question starts to surface: What’s slowing things down? The Assumption That Doesn’t Hold Many manufacturers operate under a reasonable assumption: If a product’s approved, hospitals should be able to adopt it. From a regulatory standpoint, that’s true. From a market perspective, it’s only part of the picture. Because in Brazil, hospital adoption depends on a set of dynamics that sit outside the regulatory process. And that’s where timelines tend to stretch. Approval and Adoption Follow Different Logics Regulatory approval’s a technical process. Documentation’s reviewed. Requirements are met. Compliance’s verified. Hospital adoption works differently. It’s influenced by: Clinical validation. Internal hospital processes. Budget constraints. Procurement structures. And often, existing supplier relationships. Which means that even after approval, the product still needs to go through another layer of evaluation—this time inside the hospital. The Internal Path Inside Hospitals In many Brazilian hospitals, new technologies don’t go directly from approval to purchase. They go through internal pathways that can include: Clinical committees. Technical evaluations. Cost-benefit analysis. Pilot usage or physician validation. These steps aren’t barriers. They’re part of how hospitals manage risk and ensure quality of care. But they do take time. And if manufacturers aren’t prepared for this phase, progress slows down. Distribution Alone Doesn’t Solve It Another common expectation’s that once a distributor’s in place, adoption will follow. Sometimes it does. Often, it doesn’t. Because distribution in Brazil’s not just about availability. It’s about access. A distributor may have reach—but that doesn’t automatically translate into: Clinical engagement. Hospital relationships. Influence in procurement processes. We’ve seen products with strong distributors still struggle to gain traction simply because the commercial approach wasn’t aligned with how hospitals actually adopt new technologies. The Role of Physicians Is Bigger Than Expected One of the most decisive factors in adoption’s often underestimated. Physicians. When doctors understand a technology, trust its outcomes, and see value in their practice, things move faster. Conversations inside hospitals change. Committees become more receptive. Procurement gains context. Without that clinical engagement, adoption can take significantly longer—even for high-quality products. Timing’s Often Decided Before Approval This is where things get interesting. In many cases, the speed of adoption after approval’s determined by what happened before approval. Were key hospitals already identified?Were physicians engaged early?Was the distribution strategy aligned with the product’s clinical pathway?Was there a clear plan for post-approval market access? When these elements are in place, adoption tends to move more smoothly. When they’re not, companies find themselves building the structure after approval—which naturally takes more time. The Gap Between Approval and Real Use This gap’s where many manufacturers lose momentum. Not because the product lacks value. But because the path from regulatory clearance to hospital use wasn’t fully mapped. Brazil’s not unique in this sense—but the scale and complexity of the system make this gap more visible. And more impactful. Shortening the Journey Companies that reduce time to adoption tend to approach Brazil differently. They don’t treat regulatory approval as a standalone milestone. They treat it as one step within a broader market access strategy. That includes: Planning hospital engagement early. Aligning distribution with clinical realities. Preparing for procurement dynamics. And building relationships before the product’s even approved. It’s not about accelerating one step. It’s about connecting all of them. Brazil Rewards Those Who Prepare Beyond Approval Brazil offers significant opportunities for medical device manufacturers. But it also requires a broader view of what “market entry” actually means. Approval gets you into the system. Adoption gets you into the hospital. And the companies that understand the difference are usually the ones that move faster—not slower—once approval’s granted. A Different Question to Ask Instead of asking: “How long does approval take?” A more useful question might be: “How long will it take for our product to be used inside hospitals—and what needs to happen to get there?” That shift changes the way companies prepare. And often, it shortens the journey in ways that regulation alone cannot. 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  

Most international manufacturers approach Brazil with the same initial assumption. “This is going to be complicated.” And to be fair, there are reasons for that perception. ANVISA has a rigorous regulatory framework. Documentation requires precision. Timelines need to be managed carefully. So naturally, the focus goes there first. How do we get approval?How long will it take?What do we need to prepare? All valid questions. But after working with manufacturers entering Brazil for many years, we’ve seen something that tends to surprise companies. Getting into Brazil isn’t usually the hardest part.Getting the structure wrong at the beginning is. The Part That Doesn’t Show Up in the Checklist Most market entry plans follow fairly standard logic. Regulatory approval → local partner → distribution → sales. On paper, it looks straightforward. But what often doesn’t get enough attention is how these pieces are connected—and how early decisions shape everything that comes after. Because in Brazil, structure isn’t just operational. It’s strategic. And once it’s in place, changing it can be far more difficult than expected. Where Complexity Actually Lives The complexity of Brazil’s not just regulatory. It sits in the intersection of multiple layers: Regulation. Taxation. Importation. Distribution. Hospital access. Individually, each one’s manageable. But when they’re not aligned, friction starts to appear. We’ve seen companies receive regulatory approval without a clear import structure—leading to delays at customs. Others had distribution agreements in place, but no alignment with hospital procurement dynamics—resulting in slow adoption. In many cases, the issue wasn’t execution. It was how the structure had been designed from the beginning. Small Decisions, Long-Term Consequences Some of the most impactful decisions are made very early—and often treated as simple operational choices. For example: Assigning the product registration to a distributor because it seems efficient. Choosing a single partner to handle regulatory, importation, and sales without evaluating long-term flexibility. Building a national distribution model before understanding how different regions behave. Individually, these decisions make sense. Collectively, they can create a structure that’s difficult to adjust later. We’ve seen companies that needed to change distributors but couldn’t do so without affecting their regulatory position. Others had pricing challenges because the initial tax structure wasn’t optimized. Not because the strategy was wrong.But because the structure didn’t allow it to evolve. Brazil Requires Flexibility from the Start One of the defining characteristics of the Brazilian healthcare market’s that it evolves. Commercial strategies change. Distribution needs to be expanded. New opportunities appear in different regions or specialties. Manufacturers who succeed here usually build their entry model with that in mind. They don’t try to “lock everything in” from day one. Instead, they create a structure that allows them to adapt over time. That often means: Separating regulatory control from commercial relationships. Working with partners who allow flexibility. Thinking beyond initial entry and planning for growth. It’s less about having the perfect model on day one. And more about having a model that can evolve. The Difference Between Entering and Establishing There’s a subtle but important distinction in Brazil. Some companies enter the market. Others establish a presence. The difference usually comes down to structure. Entering can be relatively fast. But building a sustainable position—one that allows growth, adjustments, and expansion—depends on how well the foundation was set. We’ve seen both scenarios. Companies that moved quickly but later had to restructure key elements of their operation. And companies that took a more deliberate approach early on—and moved with much more confidence afterward. A Different Way to Think About Market Entry Instead of asking: “How do we enter Brazil?” A more useful question might be: “How do we structure our presence in Brazil so it works not just now, but later?” That shift in perspective changes the conversation. It brings attention to decisions that don’t always seem urgent but end up being critical. And it helps avoid situations where growth’s limited not by the market, but by the initial setup. Brazil’s Complex. But It’s Not Unpredictable. There’s a tendency to see Brazil as a difficult market. And yes, it requires attention. But in many cases, what creates difficulty isn’t the market itself—it’s the misalignment between structure and strategy. When those two are aligned, things tend to move more smoothly. Regulatory processes become predictable.Operations become manageable.Market access becomes clearer. It’s a Conversation Worth Having Early Most of the challenges companies face in Brazil don’t come from major mistakes. They come from small decisions made without full visibility. And they’re often avoidable. If Brazil’s part of your international roadmap, taking the time to think through the structure early can make a significant difference later. Because in this market, success isn’t defined by how fast you enter.But how well you build what comes next. Thinking About Brazil Mark 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  

March 20, 2026 • 9 min read  Entering Brazil often starts with excitement.  It’s a large market. A sophisticated healthcare system. Strong demand for innovation.  On paper, it makes perfect sense.  But once the process begins, many manufacturers realize something:  Brazil doesn’t behave like a typical expansion market.  We’ve worked with international companies entering Brazil for years. And while every case is different, the same patterns tend to repeat.  Not because the companies lack capability.  But because a few early decisions, often made with limited local context, end up shaping everything that comes after.  Here are five of the most common ones.  1 Treating Regulatory Approval as the End Goal  Most companies approach Brazil with a clear first objective:  Get approval from ANVISA.  That makes sense. Without approval, nothing else moves.  But here’s where things start to drift.  Approval’s often treated as the finish line when in reality, it’s just the beginning.  We’ve seen manufacturers invest heavily in the regulatory process, only to realize later that they haven’t built a clear path to:  Distribution. Hospital access. Clinical adoption.  The product’s approved.  But it’s not moving.  In Brazil, regulatory clearance enables entry.  It doesn’t create demand.  2 Assigning the Registration to the Distributor  This is probably the most common structural mistake.  To simplify the process, many manufacturers allow their local distributor to act as the Brazilian Registration Holder (BRH).  At first, it feels efficient.  One partner handling everything.  But over time, this structure can become restrictive.  If the commercial relationship needs to change because of performance, expansion, or strategy, the registration remains tied to that distributor.  And suddenly, a commercial decision becomes a regulatory problem.  We’ve seen companies delay strategic moves for months—or even years—because of this.  3 Underestimating Brazil’s Tax and Import Complexity  Brazil’s regulatory process is detailed.  But the operational environment can be just as challenging.  Importation, taxation, and logistics involve multiple layers: federal, state, and sometimes even municipal.  Companies that enter the market without a clear structure often face:  Unexpected costs. Delays at customs. Pricing inconsistencies.  Not because the system’s unpredictable.  But because it requires planning.  Manufacturers who treat Brazil like a standard import market usually learn this the hard way.  4 Choosing Distribution Based Only on Reach  It’s natural to look for distributors with national coverage.  Large footprint. Established presence.  But reach alone doesn’t guarantee market access.  In Brazil, access often depends on:  Relationships with hospitals. Clinical engagement. Understanding of procurement processes. Presence in specific specialties.  We’ve seen smaller, more specialized partners outperform larger distributors simply because they were better aligned with the product and its target market.  Distribution here’s less about size.  More about fit.  5 Trying to Solve Everything at Once  Brazil can feel complex.  So the instinct’s often to build a complete structure immediately: regulatory, commercial, operational, distribution.  All at once.  But that approach can create unnecessary friction.  The companies that tend to perform better take a more structured path.  They prioritize:  A solid regulatory foundation. A flexible commercial model. Partners that allow evolution over time.  They don’t try to solve everything on day one.  They build the right structure to grow into the market.  What Successful Companies Tend to Do Differently  After seeing dozens of market entries, one thing becomes clear.  Success in Brazil isn’t about avoiding complexity.  It’s about structuring it properly from the beginning.  That usually means:  Keeping regulatory control independent. Building flexible distribution strategies. Planning market access alongside regulatory approval. And working with partners who understand how these pieces connect.  None of this is particularly complicated in isolation.  But putting it together correctly makes all the difference.  Brazil’s Worth It When Approached the Right Way  Despite the challenges, Brazil remains one of the most attractive healthcare markets in Latin America.  The opportunity’s real.  But so is the learning curve.  The manufacturers who succeed here aren’t necessarily the fastest to enter.  They’re the ones who take the time to understand how the system works and structure their entry accordingly.  A Conversation That Can Save Time  Most of these mistakes don’t come from poor decisions.  They come from incomplete visibility at the beginning.  And they’re often avoidable.  If Brazil’s part of your expansion strategy, having the right conversation early can prevent months—or years—of adjustments later.  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  

March 18, 2026 • 8 min read  Much has been said about the agreement between Mercosur and the European Union, often from the most obvious perspective: tariff reduction.  In healthcare, however, that view’s incomplete.  What’s unfolding isn’t simply a trade liberalization process. It’s a structural reconfiguration of how medical devices and pharmaceuticals enter Brazil.  And more importantly? Who captures value along the way.  The Starting Point: Inefficiency by Design  Today, the import structure in healthcare still carries significant inefficiencies.  European medical devices reach Brazil burdened by tariffs, high logistics costs, and long distribution chains. Pharmaceuticals, in addition to taxation, face further constraints related to intellectual property and regulatory requirements.  The outcome’s predictable: inflated prices and limited access.  What Changes with the Agreement—and What Doesn’t  With the agreement’s implementation, tariff reductions will occur gradually, with a more immediate impact on medical devices and equipment. These products are expected to become more competitive relatively quickly as tariffs are reduced and eventually eliminated.  Pharmaceuticals, however, follow a different trajectory.  Although tariffs will also decrease over time, market access will remain heavily influenced by non-tariff barriers, including regulatory approval by ANVISA, patent protections, and clinical data requirements.  In practical terms, this creates a clear distinction:  Medical devices respond quickly to tariff reductions.  Pharmaceuticals evolve more slowly, constrained by structural barriers.  Beyond Cost: Predictability and Access  Tariff reduction alone doesn’t transform a market.  The real impact? Predictability.  As cost structures become more stable and import dynamics clearer, new entry models begin to emerge, enabling more efficient alignment between supply and demand.  This is where the shift truly begins.  A New Supply Chain Logic  Traditionally, the flow’s been linear:  Manufacturer → Importer → Distributor → Hospital  This model fragments information, dilutes margins, and reduces efficiency.  As the agreement progresses and more integrated models evolve, this logic begins to shift toward a demand-driven, data-oriented, and coordinated structure.  This isn’t simply about removing intermediaries. It’s about redefining their roles.  Where Value Begins to Concentrate  Not all segments will benefit equally or at the same pace.  In the short term, the most significant value capture will occur in European medical devices. These products combine meaningful tariff impact, relatively lower regulatory complexity compared to pharmaceuticals, and faster adoption cycles.  Creating a more immediate return opportunity for those who can efficiently structure market entry and distribution.  Hospital equipment and diagnostic solutions follow closely, driven by high ticket size and recurring demand dynamics.  Pharmaceutical opportunities, while relevant, are more selective. Specialty and niche products tend to benefit first, given their reliance on targeted access rather than scale alone.  The Most Common Mistake: Focusing Only on Tariffs  A common misconception? That the agreement creates opportunity.  In reality, it accelerates opportunities that already exist and favors those who are prepared to capture them.  Focusing solely on tariff reduction means looking at the effect, not the underlying shift.  The real transformation lies in the reconfiguration of the supply chain.  What This Means in Practice  In the coming years, competitive advantage won’t be defined solely by product or price.  It’ll depend on the ability to integrate three critical elements:  Regulation. Market access. Distribution.  Companies that align these pillars strategically will gain a clear advantage—not only in entering the market, but in establishing long-term relevance.  A Window That Won’t Remain Open  The agreement creates a critical timing window.  In the early years, while tariff reductions are still unfolding and competition hasn’t fully adapted, there’s an opportunity to capture higher margins and secure positioning.  Over time? This advantage will narrow as the market matures.  Conclusion: This Isn’t About Trade—It’s About Positioning  The Mercosur–European Union agreement doesn’t just reshape trade.  It reshapes who leads market access.  In healthcare, leadership won’t be defined by who has the best product alone, but by who can turn complexity into strategy and strategy into execution.  Because ultimately, this isn’t just about lowering costs.  It’s about controlling how and by whom the market is accessed.  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  

For years, international expansion in the medical device sector followed a predictable yet inefficient path. Each new market meant restarting regulatory processes, duplicating technical documentation, and navigating different requirements, often with little added value in terms of quality or safety. The outcome was clear: delays, increased costs, and, most importantly, slower patient access to innovation. That model, however, is being steadily replaced by a more intelligent and inevitable approach: regulatory reliance. From Redundancy to Regulatory Efficiency At its core, reliance’s built on a simple but powerful idea: regulatory authorities can leverage assessments already conducted by trusted agencies as part of their own decision-making processes. This doesn’t mean giving up regulatory sovereignty. On the contrary, it allows authorities to focus on what truly matters. Local context. Specific risks. Healthcare system needs. All while avoiding duplication of well-established technical evaluations. In practice? This represents a structural shift in how medical devices are regulated globally. The Strategic Impact on the Industry For companies, this transformation goes far beyond regulatory affairs. It reshapes how market access strategies are designed. Three key impacts stand out: 1. Reduced redundancy and greater operational efficiencyHarmonizing evidence across markets significantly decreases the need for multiple independent submissions. 2. Increased regulatory predictabilityGreater alignment between authorities provides clearer visibility on how approvals in reference markets influence other jurisdictions. 3. Faster time-to-marketLess duplication translates into shorter timelines between development and commercialization, which is a critical factor in an increasingly competitive industry. However, one point deserves attention: companies that fail to adapt to this logic risk losing relevance. Trust: The Foundation of the Model Despite its advantages, reliance still faces a central challenge: building trust among regulatory authorities. Issues such as data confidentiality, transparency, and technical alignment remain sensitive topics. That’s why the most successful models adopt a progressive approach, starting with lower-risk products, bilateral agreements, and pilot initiatives. The evolution’s gradual, but consistent. From Regulatory to Strategic: A Shift in Mindset One of the biggest mistakes organizations can make right now? Treating reliance as purely a regulatory topic. In reality, it requires a broader strategic mindset. Companies must begin thinking globally from the earliest stages of development, structuring evidence consistently, aligning requirements across markets, and anticipating regulatory pathways. This shift impacts: What Comes Next The advancement of reliance isn’t theoretical. It’s already happening. Driven by increasing technological complexity, particularly with software and AI-enabled devices, this model’s expected to expand and consolidate as a global standard. In this context, regulatory collaboration’s no longer optional. It’s operationally necessary. Conclusion: Competitive Advantage Starts Before Submission If there’s one clear takeaway, it’s this: competitive advantage in the medical device sector’s being built earlier than ever. It doesn’t start at submission. It starts with strategy. Companies that successfully integrate regulatory intelligence, global vision, and technical consistency will be better positioned to navigate this new environment. Others? They’ll continue operating within a model that’s gradually becoming obsolete. 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  

Getting regulatory approval in Brazil feels like the finish line for many manufacturers. Months of preparation. Documentation. Technical files. Interactions with ANVISA. When the approval finally comes through, the natural reaction is simple: Great. Now we can start selling. But Brazil doesn’t quite work that way. Regulatory approval is important. Absolutely necessary. It’s just not the moment the market opens. In reality, approval is the moment the next phase begins. Approval allows entry. It doesn’t guarantee adoption. We’ve watched this pattern many times. A manufacturer receives ANVISA approval and expects the commercial process to move quickly. After all, the product is now legally authorized in the country. Hospitals should be ready. Distributors should be eager. Sales should follow. And yet, months later, adoption is slower than expected. Sometimes much slower. Why? Because hospital adoption in Brazil depends on a set of dynamics that exist beyond regulatory approval. Understanding those dynamics early makes an enormous difference. Hospitals don’t buy approvals. They buy solutions. From a regulatory perspective, approval means the product meets safety and performance requirements. From a hospital’s perspective, that’s just the starting point. Procurement teams, clinical committees, and hospital administrators evaluate different questions: How does this technology compare with existing alternatives? Does it improve clinical outcomes? Does it reduce operational costs or complications? How does it fit into current clinical protocols? In many institutions, new technologies must also pass through clinical evaluation committees before being incorporated into purchasing lists. That process takes time. Relationships matter. Clinical evidence matters. Physician advocacy matters. Approval opens the door. Adoption requires a different kind of work. The importance of the right distribution structure Another factor that shapes adoption is distribution. Brazil’s healthcare system is geographically vast and commercially fragmented. Thousands of hospitals operate under different purchasing models private networks, independent hospitals, regional groups, and public institutions. No single distributor reaches them all effectively. Manufacturers who succeed here usually build distribution strategies designed around market access, not just logistics. That means working with partners who understand: hospital procurement dynamics clinical engagement local reimbursement realities and the nuances of regional healthcare markets In other words, distribution in Brazil isn’t just about delivering products. It’s about opening doors. Clinical champions often make the difference One of the most underestimated drivers of hospital adoption in Brazil is physician advocacy. When clinicians understand a technology, trust its performance, and see value for their patients, adoption accelerates. Without that clinical engagement, even well positioned products can take much longer to gain traction. Manufacturers entering Brazil often underestimate the importance of building relationships with key physicians and clinical opinion leaders early in the process. But in practice, those relationships often determine how quickly hospitals incorporate new technologies. Market access is a journey Regulatory approval, distribution partnerships, physician engagement, hospital procurement. Each of these steps plays a role in turning an approved product into a product that is actually used inside hospitals. And the timeline between approval and adoption can vary widely depending on how these elements come together. Some manufacturers reach hospital adoption quickly because they planned the commercial strategy early. Others spend months adjusting the structure after approval. Not because the product lacks value. But because market access requires more than regulatory clearance. Brazil rewards preparation Brazil is one of the most attractive healthcare markets in Latin America. Large hospital networks. Advanced clinical centers. Growing demand for medical technology. But like many complex markets, success usually belongs to manufacturers who think beyond the first milestone. Approval matters. Adoption matters more. And the companies that prepare for both from the beginning are the ones that build sustainable growth in the Brazilian market. Thinking about Brazil? Every product follows a slightly different path to hospital adoption. Different specialties. Different hospital dynamics. Different procurement realities. But the journey from regulatory approval to real clinical use always involves more than one step. If Brazil is part of your international strategy, it’s worth mapping that journey carefully from the start.  It can make the difference between entering the market… and truly establishing a presence in it.  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  

Most manufacturers looking at Brazil for the first time assume the regulatory hurdle is the main challenge. ANVISA approval. Documentation. Timelines. Important? Sure. But in 30 years of watching market entries, that’s not where things actually break. The real issue shows up earlier. Way earlier. Who holds the registration in Brazil. And that decision (often treated as a procedural checkbox) ends up shaping everything that follows. Distribution. Pricing power. Market control. The long-term value of your brand in the country. We’ve seen this play out hundreds of times. The Structural Reality of Brazil Brazilian regulation requires medical devices be registered with ANVISA by a Brazilian legal entity. Foreign manufacturers can’t hold it directly. That local entity becomes the Brazilian Registration Holder, or BRH. On paper, sounds administrative. Just appoint someone local and move forward, right? In practice? The BRH controls the regulatory asset that allows your product to exist in the Brazilian market. That changes everything. Because whoever holds the registration effectively controls regulatory maintenance, renewals and variations, import authorization, and in many cases, the entire commercial pathway of the product. It’s not a workaround. Not a technicality. It’s a structural feature of the Brazilian system. Where Things Start Going Wrong Here’s what usually happens. Manufacturers entering Brazil choose the obvious option. They give the registration to their local distributor. Makes sense at first. One partner handling everything: regulatory, importation, sales. Simple. Until it isn’t. Once the distributor holds the registration, switching partners becomes dramatically harder. We’ve seen manufacturers need to change distributors for legitimate reasons. Performance issues. Strategy shifts. Market expansion. But the registration was in the distributor’s name. Now you’ve got two options. Start the regulatory process from zero. Or renegotiate from a position with almost no leverage. Neither’s attractive. The Registration Is More Than a Regulatory File Think about the registration differently. It’s not a regulatory step. It’s a strategic asset. It represents your regulatory presence. Your continuity in the market. Your independence from commercial partners. When the structure’s wrong from day one, manufacturers spend years working around it. Not because Brazil’s complicated (though it can be), but because the original setup boxed them in. And that’s expensive. In time, money, and opportunity cost. A More Sustainable Model Manufacturers who approach Brazil strategically usually separate regulatory control from commercial distribution. The BRH holds the registration and manages regulatory obligations. That’s it. Distributors focus on what they do best: selling, servicing hospitals, growing market share. This structure creates flexibility. If your commercial strategy evolves (and it often does), you can adjust distribution without jeopardizing the regulatory foundation. In a market the size of Brazil, that flexibility matters. A lot. Brazil Rewards Long-Term Thinking Brazil’s the largest healthcare market in Latin America. Hospitals are sophisticated. Procurement processes are complex. Relationships take time. Manufacturers who succeed here take a longer view. They build the regulatory structure right from the beginning. They maintain control over registrations. They design commercial partnerships that can evolve as the market develops. It’s not the fastest path. But it’s the one that works. A Conversation Worth Having Every manufacturer’s situation is different. Different product classes. Different regulatory pathways. Different commercial strategies. So the right BRH structure depends on your specific business. No template answers. But one thing’s consistent across every situation we’ve seen: Choosing the right model before entering the market avoids years of unnecessary friction later. If Brazil’s on your strategic roadmap, it’s worth talking through. Not because we have all the answers, but because the questions matter more than most manufacturers realize until they’re already committed. 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 widely recognized as the largest healthcare market in Latin America and one of the most promising destinations for global medical device manufacturers. With a complex regulatory framework and strong demand for innovative technologies, the country offers significant opportunities but also requires a structured approach to market entry.  One of the most effective strategies for international companies seeking to enter the Brazilian market is regulatory hosting, a model that enables manufacturers to operate locally without the need to establish a subsidiary or build a full regulatory and operational structure from scratch.  At Brisa, regulatory hosting is more than an administrative service. It is a strategic gateway that allows global manufacturers to access the Brazilian healthcare ecosystem with agility, compliance, and commercial readiness.  Understanding Regulatory Hosting in Brazil  In Brazil, medical devices must be registered or notified with the national regulatory authority, the Agência Nacional de Vigilância Sanitária (ANVISA). To complete this process, foreign manufacturers must appoint a Brazilian Registration Holder (BRH), a locally established entity legally responsible for the product registration and its compliance with Brazilian regulations.  Regulatory hosting is the model through which a qualified Brazilian partner assumes this role on behalf of the manufacturer. This structure allows international companies to:  However, the effectiveness of this model depends heavily on the quality, governance, and strategic vision of the hosting partner.  Beyond Compliance: The Strategic Value of Regulatory Hosting  While regulatory hosting is often perceived as a legal requirement, in practice it can become a powerful business accelerator when managed strategically. A specialized partner can help manufacturers:  The Brisa Model: Regulatory Hosting Within an Integrated Ecosystem  What differentiates Brisa is that regulatory hosting is not offered in isolation. Instead, it is part of an integrated ecosystem that connects regulatory strategy, market access, purchasing networks, and distribution capabilities. This model enables manufacturers to move seamlessly from regulatory approval to commercial execution.  Within the Brisa ecosystem, regulatory hosting connects directly with:  This integrated approach reduces fragmentation and eliminates the need to coordinate multiple independent partners across the regulatory and commercial journey. For global manufacturers, the result is a simpler, faster, and more secure entry into the Brazilian healthcare market.  A Strategic Bridge Between Innovation and Market Access  Brazil’s healthcare system continues to evolve rapidly, driven by technological innovation, demographic shifts, and increasing demand for advanced medical solutions. In this environment, regulatory hosting becomes more than a compliance mechanism; it becomes a strategic bridge between global innovation and local healthcare delivery.  By combining regulatory expertise with operational and commercial capabilities, Brisa helps manufacturers transform regulatory approval into real market presence. Because entering a new market should not be defined by complexity, but by opportunity.  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  

When Time Equals Value: How Efficient Regulation Drives Innovation and Growth  In healthcare, every regulatory decision carries economic weight. From the moment a medical device begins its approval process to the point it reaches the market, time, cost, and opportunity are inseparably linked. Efficient regulatory systems not only protect patients but they also stimulate innovation, attract investment, and strengthen competitiveness.  At Brisa, we see regulatory efficiency as both a public health priority and a strategic economic driver for the medical device industry.  1. The Economics of Time to Market  For medical device manufacturers, time to market is one of the most critical business metrics. Every month of delay in regulatory approval can mean postponed revenue, missed hospital procurement cycles, and delayed access for patients. Studies show that reducing approval timelines while maintaining quality and safety directly translates into:  Faster return on investment (ROI);  Lower operational costs;  Earlier feedback from real-world use;  Stronger reinvestment capacity for R&D.  In emerging markets like Brazil, where healthcare demand is growing rapidly, shortening this journey without compromising rigor creates a win-win scenario for companies, regulators, and patients alike.  2. Regulation as an Economic Enabler  Regulation is often viewed as a cost center but when well-structured, it becomes a growth catalyst. By providing predictability, transparency, and risk-based oversight, regulatory efficiency enables companies to plan and invest with confidence. Efficient frameworks also improve national competitiveness.  Countries that streamline regulatory processes tend to:  Attract more foreign manufacturers seeking stable market conditions;  Stimulate local innovation by reducing administrative barriers;  Enhance public health outcomes, which in turn drive productivity and social development.  In this sense, regulatory efficiency is not just good governance; it is economic strategy.  3. The Brazilian Context: Progress Through Modernization  Over the past decade, Anvisa has made significant progress toward modernization. Initiatives such as digital submissions, harmonization with the International Medical Device Regulators Forum, and risk-based evaluations have increased transparency and reduced bureaucracy.  Resolutions like RDC 751/2022 which redefined the classification and registration of medical devices are evidence of this evolution. These reforms have improved alignment with international standards while maintaining Brazil’s high level of regulatory rigor. The result is faster approvals, stronger oversight, and a growing reputation for regulatory reliability in Latin America.  4. How Brisa Creates Economic Value Through Regulatory Strategy  At Brisa, we help manufacturers capture the full economic potential of efficient regulation. Our integrated ecosystem combines technical expertise, data-driven analysis, and operational agility to reduce delays, avoid rework, and optimize cost across the entire regulatory lifecycle.  We support our clients by:  Designing efficient registration strategies based on product risk and market goals;  Anticipating and adapting to Anvisa’s evolving requirements;  Streamlining documentation and technical justification;  Managing renewals, post-market surveillance, and quality compliance.  By aligning compliance with business priorities, Brisa turns regulatory management into a strategic investment: one that drives growth rather than restricts it.  5. The Multiplier Effect of Efficiency  Regulatory efficiency produces a ripple effect across the entire healthcare ecosystem:  Manufacturers gain faster access and reduced costs;  Distributors benefit from predictability and portfolio expansion;  Healthcare providers access new technologies sooner;  Patients receive safer, more advanced care faster;  Regulators strengthen oversight through clearer data and governance.  In the long term, this synergy supports a more competitive, innovative, and sustainable healthcare market.  6. Conclusion: Efficiency as a Shared Responsibility  Regulatory efficiency is not achieved by speed alone; it is about balance. It requires collaboration between regulators, industry, and consulting partners who share the same purpose: ensuring safety while enabling innovation.  At Brisa, we believe that when regulation works efficiently, everyone benefits from global manufacturers to local healthcare systems and, ultimately, to the patients whose lives depend on timely access to innovation. Because in healthcare, e  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 world of healthcare, success depends not only on technical expertise, but on trust, transparency, and partnership.  Manufacturers, distributors, regulatory agencies, and consultants each play a critical role in ensuring that innovative medical technologies reach patients safely and efficiently. At Brisa, we believe that lasting success in the Brazilian healthcare market is built through long-term partnerships, not transactional relationships.  Our approach combines deep regulatory knowledge with a collaborative mindset, turning compliance into connection and complexity into opportunity.  1. The Importance of Collaboration in Healthcare  The healthcare value chain is increasingly interconnected.  A single medical device’s journey involves dozens of stakeholders, from engineers and clinical evaluators to importers, regulators, and end users. Without collaboration, that chain becomes fragmented. With collaboration, it becomes a living ecosystem, capable of adapting, sharing knowledge, and creating collective value.  For international manufacturers entering Brazil, collaboration with the right local partner is the difference between market entry and market success. A strong partnership ensures alignment across regulatory, logistical, and commercial fronts, resulting in faster access, reduced risk, and higher trust among all players involved.  2. Partnership as a Strategic Advantage  In a sector defined by regulatory rigor and constant evolution, long-term partnerships provide stability. They create a framework for shared learning, joint problem-solving, and continuous improvement.  At Brisa, we act as more than a regulatory consultant. We become an extension of our clients’ teams, helping them make informed decisions, anticipate regulatory changes, and build strategies for sustainable growth. This long-term vision enables manufacturers to focus on innovation, while Brisa ensures that every step, from registration to distribution, operates smoothly and in full compliance.  3. The Brisa Ecosystem: Connecting Expertise and Execution  Our integrated model is designed to unite all aspects of market access under one collaborative structure. Within the Brisa ecosystem, we combine:  Regulatory consulting, ensuring compliance with Anvisa and international standards.  Legal representation, acting as a trusted partner for foreign manufacturers.  Importation and logistics, optimizing cost, timing, and tax efficiency.  Strategic distribution networks, linking products to healthcare providers and buyers across Brazil.  This ecosystem allows information to flow transparently between stakeholders, eliminating silos and ensuring that innovation moves seamlessly from concept to clinic.  4. Trust and Transparency: The Foundation of Every Partnership  Every partnership we build at Brisa is rooted in trust and transparency. Our clients have full visibility of their regulatory and operational processes, supported by clear governance and open communication.  We believe that trust is not declared; it’s demonstrated. It’s built through consistent delivery, reliability, and the ability to transform challenges into measurable results. That’s why many of our international clients see Brisa not only as a service provider but as a strategic ally, one that understands their goals and shares their commitment to excellence.  5. From Partnership to Shared Growth  True partnership goes beyond contracts. It means growing together, adapting together, and learning from each success and challenge.  In healthcare, where innovation evolves faster than regulation, shared growth ensures agility. It allows companies and consultants to co-create strategies that anticipate change rather than react to it. At Brisa, we’re proud to have built long-standing relationships based on mutual respect and a shared mission: to connect global innovation with Brazilian healthcare needs, responsibly and sustainably.  6. Conclusion: Collaboration as the Future of Healthcare  The future of healthcare will be collaborative. As technologies become more complex and global, no single organization can succeed in isolation.  At Brisa, our approach is simple but powerful: partnership over transaction, collaboration over competition, and trust over convenience. Because when we work together, across borders, disciplines, and systems, innovation moves faster, access becomes broader, and patient outcomes improve.  That’s the Brisa way: partnership with purpose.  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