At some point, the question comes up.  Usually in a strategy meeting. Sometimes in a regional expansion discussion.  “Should we enter Brazil?”  It’s a fair question.  Brazil is the largest healthcare market in Latin America. The demand is real. The opportunity is clear.  But shortly after that first question, others start to follow.  How complex is the regulatory process? How long will it take? Who should we work with locally? What kind of structure do we need?  And this is where things become less straightforward.  Most companies don’t struggle with the decision to enter  In our experience, the decision to explore Brazil is rarely the difficult part.  The real challenge is how that decision is executed.  Because entering Brazil isn’t a single step.  It’s a sequence of interconnected choices:  Key decisions that define your Brazil operation:  Who will hold your registration  How your regulatory strategy is structured  How importation and taxation will impact your pricing  Which partners will represent your product in the market  How hospitals will actually adopt your technology  Individually, these decisions seem manageable.  But together, they define how your business will operate in Brazil for years.  Early decisions tend to stay with you  One of the characteristics of the Brazilian market is that initial structures aren’t always easy to change later.  We’ve seen companies:  • needing to restructure their distribution—but unable to do so without regulatory implications • adjusting pricing strategies due to tax structures defined early on • revisiting their market approach after realizing adoption was slower than expected  None of these situations come from poor decisions.  They come from decisions made without full visibility.  And that’s understandable—especially when entering a new market.  In Brazil, the way you enter often defines how you grow.  What usually makes the difference  When market entry works well, there’s usually a common pattern.  Companies take a step back before moving forward.  They don’t rush to appoint partners or define structures.  Instead, they spend time understanding how the pieces connect.  Regulation with commercial strategy. Distribution with hospital access. Tax structure with pricing and competitiveness.  That alignment early on tends to prevent a lot of adjustments later.  A conversation that changes perspective  Sometimes, what companies need at this stage isn’t a full plan.  It’s a clearer view of the landscape.  What are the possible models? What are the trade-offs? What tends to work—and what tends to create limitations later?  These aren’t always obvious from the outside.  And they don’t always show up in standard market entry checklists.  But they make a difference.  Brazil is complex—but not inaccessible  There’s a tendency to position Brazil as a difficult market.  And while it does require attention, most challenges become manageable with the right structure.  The companies that succeed here aren’t necessarily the ones that move the fastest.  They’re the ones that take the time to structure their entry properly.  Once that foundation is in place, things tend to move with more clarity—and more confidence.  Before moving forward, it’s worth pausing  If Brazil is on your roadmap, there’s value in pausing before making key decisions.  Not to slow things down.  But to ensure that the structure you build now will support where you want to go later.  Because in this market, the way you enter often defines how you grow.  Let’s have the right conversation early  Every manufacturer’s situation is different.  Different products. Different timelines. Different strategic priorities.  Which means there is no single “correct” model.  But there are better-informed decisions.  And those usually start with the right conversation.  If you’re evaluating Brazil, we’re always available to exchange perspectives.  No pressure. No predefined path.  Just a discussion to help you move forward with more clarity.  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 international manufacturers enter Brazil, the structure usually follows a familiar pattern.  One partner for regulatory. Another for legal representation. A third for importation and logistics. And one (or more) for distribution.  Four different partners. Sometimes more.  On paper, it makes sense.  Each one handles a specific part of the process. Each brings specialized expertise.  It feels structured.  But in practice, something else starts to happen.  The Hidden Cost of Fragmentation  At the beginning, the model works.  Regulatory moves forward. Importation’s arranged. Distribution’s set up.  But as operations start to scale, small misalignments begin to appear.  Communication gaps. Different timelines. Conflicting priorities.  Nothing dramatic at first.  Just friction.  But over time, that friction adds up.  We’ve seen situations where:  A regulatory update didn’t reach the logistics team in time. Importation was delayed due to missing documentation alignment. Pricing structures were affected by tax decisions made in isolation. Distribution moved ahead without full visibility of regulatory constraints.  Not because partners weren’t capable. But because they were operating independently.  More Partners Doesn’t Always Mean More Control  There’s a common assumption behind the fragmented model:  More partners = more specialization = better results.  In theory, that’s true.  In reality, it often creates something different.  More interfaces. More coordination. More room for misalignment.  And in a market like Brazil—where regulation, taxation, and operations are deeply interconnected—that misalignment can slow things down quickly.  Control doesn’t come from having more players.  It comes from having alignment between them.  The Complexity’s Not in the Parts. It’s in How They Connect.  Each component of the Brazilian market entry process’s manageable on its own.  Regulation can be navigated. Importation can be structured. Distribution can be built.  The challenge’s how these elements interact.  A regulatory decision can impact tax exposure.  A tax structure can influence pricing.  Pricing affects hospital adoption.  Distribution depends on all of the above.  When these pieces are handled separately, the connections between them often get overlooked.  And that’s where inefficiencies appear.  What Changes When the Model’s Integrated  Some manufacturers take a different approach.  Instead of coordinating multiple independent partners, they work with a structure where these elements are already connected.  Regulatory, legal representation, importation, and distribution operate within the same ecosystem.  What changes isn’t just simplicity.  It’s visibility.  With an integrated model:  Decisions are made with a full view of their impact across the operation. Timelines align more naturally. Information flows without needing to be constantly translated between different parties. And most importantly, the structure becomes easier to adapt.  Fewer Handoffs. More Continuity.  One of the biggest differences we see in integrated models’s continuity.  In a fragmented structure, every transition between partners’s a potential point of friction.  Information needs to be passed on. Context needs to be rebuilt.  Sometimes things get lost along the way.  With fewer handoffs, that process becomes smoother.  Not perfect—but more predictable.  And in a market where timing and compliance matter, predictability has real value.  It’s Not About Reducing Partners. It’s About Reducing Friction.  This isn’t about saying that multiple partners don’t work.  They can—and often do.  But they require a high level of coordination to function effectively.  And that coordination usually falls on the manufacturer.  For companies entering Brazil for the first time, that can be more demanding than expected.  An integrated approach shifts that dynamic.  Instead of managing the connections, the manufacturer works with a structure where those connections are already built.  A Different Way to Think About Control  At first glance, having multiple partners can feel like having more control.  But in practice, control often comes from clarity.  Control comes from:  Knowing how decisions in one area affect another  Understanding timelines across the entire operation  Having visibility into the full process—not just individual parts  That’s what allows companies to move with confidence.  Brazil Doesn’t Simplify Itself. But Your Structure Can.  Brazil will always have a certain level of complexity.  That’s part of the market.  But the way that complexity’s managed makes a significant difference.  Some companies experience it as friction.  Others experience it as a structured, manageable system.  The difference’s rarely the market itself.  It’s how the operation’s designed from the beginning.  One Partner Doesn’t Mean Less Capability  It often means the opposite.  When the right structure’s in place, integration brings:  Alignment — All elements working toward the same goals  Speed — Fewer delays from handoffs and miscommunication  Visibility — Full view of how decisions impact the operation  Flexibility — Easier to adapt as the market evolves  And those are the elements that tend to define successful market entry over time.  A Question Worth Asking Early  Before building a structure with multiple independent partners, it’s worth asking:  How will all of this connect once we start operating?  Because in Brazil, success isn’t just about having the right pieces.  It’s about how well they work together.  Thinking About Your Brazil Structure?  Let’s discuss whether a fragmented or integrated model makes more sense for your entry 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  

When international manufacturers start evaluating Brazil, the conversation tends to go in a very predictable direction. “Who’s the right distributor?” It’s usually one of the first questions. And it makes sense. Brazil’s a large country. Complex geography. Diverse healthcare system. So naturally, the instinct’s to solve for distribution early. Find a strong partner. Ensure national coverage. Move forward. But after working with companies entering Brazil for years, we’ve seen something that challenges that assumption. In most cases, distribution isn’t the real problem.Market access is. The Logic That Feels Right But Isn’t Enough The typical approach looks something like this: Get regulatory approval → appoint a distributor → start selling. On paper, it works. In practice, something often doesn’t click. Products are available. Stock’s in place. The distributor’s active. And yet, adoption’s slower than expected. Hospitals take time to incorporate the product. Demand builds gradually or sometimes not at all. At that point, the question shifts. “Is the distributor underperforming?” Sometimes that’s true. But often, the issue sits somewhere else. Distribution Delivers Products. Market Access Creates Demand. There’s an important distinction here. Distribution’s about logistics and reach. Getting the product into the country. Moving it across regions. Making it available. Market access is about something different. It’s about: How hospitals evaluate new technologies. How procurement decisions are made. How physicians influence adoption. How products are positioned clinically and economically. Distribution answers:Can the product get there? Market access answers:Will anyone actually use it? Why This Gap Matters in Brazil Brazil’s healthcare system’s not centralized. Hospitals operate with a high degree of autonomy. Procurement processes vary. Clinical decision making often involves multiple stakeholders. Which means that simply having a product available doesn’t guarantee adoption. We’ve seen situations where: Products were widely distributed but rarely used.Distributors had strong coverage but limited clinical engagement.Inventory was available but demand never really took off. Not because the product lacked value.But because the market hadn’t been activated. The Role Distributors Can and Can’t Play This is where expectations sometimes get misaligned. Distributors are essential. They play a critical role in navigating the market. But they’re not always structured to handle every aspect of market access. Some are excellent at logistics. Others have strong hospital relationships. A few combine both with clinical engagement. But expecting a single partner to fully bridge regulatory, commercial, and clinical dynamics—without a defined strategy can lead to gaps. And those gaps show up in adoption. What Successful Companies Tend to Do Differently Manufacturers who gain traction in Brazil usually approach the market in a more layered way. They don’t rely on distribution alone to drive growth. They think about: How the product will be positioned clinically. Which hospitals are priorities. How physicians will be engaged. What evidence’s needed for adoption. How procurement conversations will unfold. Distribution becomes one part of a broader strategy. Not the strategy itself. Market Access Starts Earlier Than Most Think One of the most important shifts we see in successful market entries’s timing. Companies that wait until after regulatory approval to think about market access often lose momentum. Those who start earlier sometimes well before approval tend to move faster once the product’s cleared. Because the groundwork’s already in place. Relationships are established. Conversations have started. The market’s more prepared. By the time the product’s available, adoption doesn’t need to start from zero. A Different Way to Approach Brazil Instead of asking: “Who should distribute our product?” A more effective question might be: “How will our product be adopted inside hospitals and what needs to happen to get there?” That shift changes everything. It expands the conversation beyond logistics. And brings focus to the elements that actually drive growth. Brazil Rewards Those Who Connect the Dots Brazil’s not an easy market. But it’s also not an unpredictable one. When regulatory strategy, distribution, and market access are aligned, things tend to move. Adoption becomes more consistent. Growth becomes more sustainable. When they’re not, companies often find themselves trying to fix the structure after the fact. And that’s where time—and opportunity—is lost. It’s Not About Distribution Alone Distribution matters. A lot. But on its own, it rarely solves the full challenge. Because in Brazil, success isn’t just about getting products into the country. It’s about getting them into the hands of physicians and into the routine of hospitals. And that requires more than reach.It requires access. 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  

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