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
