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