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 
