Question 1

How do international manufacturers sell medical devices in Brazil?

Accepted Answer

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.

Question 2

Why is selling into Brazil so expensive — where does the margin go?

Accepted Answer

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.

Question 3

What's the risk of letting a Brazilian distributor hold my registration?

Accepted Answer

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.

Question 4

What's the fastest path from product to a Brazilian hospital?

Accepted Answer

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.

Question 5

How does the GROPO model protect my pricing and my registration?

Accepted Answer

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.

Sell into Brazil without losing half your price to stacked margin.

Traditional distribution adds layers of margin.

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

We add layers of efficiency.

Four pillars, one infrastructure.

Brazil Import Healthcare Solutions (BIHS)

GROPO

Alliance Club

Medical Distributors Brazil (MDB)

Built to remove the layers, not add one.

No margin-stacking

Independent registration

National reach, built to scale

AI-powered demand

Public tender access

30+ years of expertise

Three decades, one approval rate that matters.

How manufacturers enter Brazil.

Ready to enter Brazil the efficient way?