Brazil · Medical Device Market Access Infrastructure

Sell into Brazil without losing half your price to

BRISA Advisors takes international medical device manufacturers from ANVISA registration to live hospital demand — replacing a chain of importers and distributors with one qualified market-access infrastructure.

30+
Years, since 1995
US$16.15B
Brazil MD market, 2025
600+
Manufacturers served
100%
ANVISA approval, 2025
The problem

Traditional distribution adds layers of margin.

The conventional route into Brazil sends every product through a chain — importer, master distributor, regional distributor — each adding margin, tax and delay before the device reaches a hospital.

On an imported device, import duties and taxes (II, IPI, PIS/COFINS, ICMS) add roughly 30–40% over the factory price, and every layer adds its own margin. Long payment cycles compound it: suppliers wait on average ~139 days to be paid (ABRAIDI, 2025), and that financing cost is priced in too.

Manufacturer
Importer
+margin +tax
Master distributor
+margin
Regional distributor
+margin +delay
Hospital

And the biggest decision of all: who holds your registration.

In the traditional model the distributor is usually the registration holder and owns the hospital relationship — handing them enormous bargaining power. If the relationship sours, you can't simply switch channels: without the current holder's cooperation, your product can be locked out of the market entirely.

How it works

Four pillars, one infrastructure.

Regulatory entry

Brazil Import Healthcare Solutions (BIHS)

Your independent Brazil Registration Holder (BRH) before ANVISA, keeping your registration separate from any single distributor — from initial registration through post-market obligations.

AI-powered B2B procurement

gropo

A group-purchasing and direct-import B2B procurement platform that runs the exchange between manufacturers and hospital buyers — removing the intermediary and tax layers that erode competitiveness.

National distribution

Alliance Club

A credentialed distributor network where distributors are developed by specialty and on demand, building last-mile coverage across Brazil's 27 state capitals.

Entry point

Medical Distributors Brazil (MDB)

The digital front door where international manufacturers begin the market-access journey.

Track record & market

Three decades, one approval rate that matters.

600+
Manufacturers served
2,600+
Products registered (2,800+ in 2026)
100%
ANVISA approval rate, 2025
27
State capitals in the distribution model

Market context.

FAQ

How manufacturers enter Brazil.

How do international manufacturers sell medical devices in Brazil?+
A foreign manufacturer without a Brazilian entity needs two things: an ANVISA registration held by a local legal entity with the required sanitary licenses (Sanitary License and AFE, the Company Operating Authorization), and a route to hospital buyers. The traditional answer is a chain of importers and distributors. BRISA Advisors replaces that chain with a single market-access infrastructure — regulatory entry through Brazil Import Healthcare Solutions (BIHS), then AI-powered group-purchasing and direct-import B2B procurement through gropo into a national hospital and distribution network.
Why is selling into Brazil so expensive — where does the margin go?+
On an imported device, the factory price is only the starting point. Import duties and taxes (II, IPI, PIS/COFINS, ICMS) add roughly 30–40%, and every distribution layer adds its own margin. Long payment cycles compound it: suppliers in Brazil wait on average around 139 days to be paid (and up to ~179 days in private insurance), and that financing cost is priced in too. BRISA shortens the chain and removes the intermediary layers, so the price a hospital pays is built on your product — not on a stack of resellers and financing costs.
What's the risk of letting a Brazilian distributor hold my registration?+
If your distributor is also your registration holder, your market authorization is tied to that single relationship — and Brazilian rules let a registration transfer only with the current holder's cooperation, so a strained relationship can leave you stuck or shut out of the market. BRISA keeps your registration with Brazil Import Healthcare Solutions (BIHS) as an independent holder, separate from any one distributor, so your market access is never hostage to a single channel — and you stay free to choose your distributors.
What's the fastest path from product to a Brazilian hospital?+
Registration first, then demand. BIHS secures and maintains your ANVISA registration; once it is published, your products are onboarded to gropo, an AI-powered B2B procurement platform that connects directly to hospital buyers, with last-mile coverage through the Alliance Club distribution network — where distributors can be developed by specialty and on demand across Brazil's 27 state capitals. One package moves you from regulatory entry to real hospital demand without building a distribution chain.
How does the gropo model protect my pricing and my registration?+
Two ways. Your registration sits with BIHS as an independent Brazil Registration Holder (BRH), never controlled by a single distributor. And instead of a fragmented reseller web that each add margin, gropo is one qualified, transparent channel. Behind it, the Mercosur Health Trade Hub is the single point of contact on both sides — qualifying manufacturers and hospital buyers and consolidating demand — so your product reaches the market at a more competitive landed price than the traditional layered chain allows.

Ready to enter Brazil the efficient way?

From registration to hospital demand, under one infrastructure. Let's map your market-access path.