Brazil—A tantalizing market, and sky-high ticket prices.

In 2025, Brazil’s total medical device spending is projected to reach US$15.5 billion (R$85.4 billion), up 13.9% year over year. It is the largest single market in Latin America—by far.

Among a population of 212.7 million, the share of individuals aged 60 and older has risen from 11.3% in 2012 to 16.6% by 2025, corresponding to approximately 35.2 million people. There are 16.62 million diabetes patients, and the number of individuals with cardiovascular diseases continues to grow. These individuals are not mere statistics; they are the everyday users of orthopedic implants, cardiac stents, blood glucose monitors, and in vitro diagnostic reagents.

Brazil’s private healthcare system is undergoing rapid expansion. Take Rede D’Or as an example: in 2025, it reported revenue of 60.4 billion reais, up 10.3% year over year, with EBITDA reaching 10.4 billion reais, a 23.2% increase compared to the previous year, and performing 570,000 surgical procedures, up 14.3% from the prior year. Private health insurance covers 53 million people, with per capita annual spending of 6,495 reais—nearly twice the per capita expenditure of the public system. These people are paying for better healthcare.

Frankly speaking, Brazil is one of the toughest nuts to crack among emerging markets. If we were to rank Latin American countries by entry difficulty, Brazil would very likely come in first. The main challenges boil down to three key issues.

Brazil’s National Health Surveillance Agency (ANVISA) is the most stringent medical device regulatory authority in Latin America. From initiation to approval, a product typically requires more than 12 to 24 months.
More critically, ANVISA’s review process differs from both China’s NMPA and the European MDR. It follows its own lengthy and cumbersome timeline. If any step in your submission is missing—whether it’s failing to obtain BGMP certification, presenting insufficient clinical data, or even having imprecise Portuguese translations—it could all result in the complete loss of your efforts.

But the real killer is the BRH system.
Brazilian law stipulates that foreign manufacturers may not hold a medical device registration certificate in Brazil under their own name. You must designate a local Brazilian entity as the Brazilian Registration Holder (BRH).
This gives rise to a core risk: the registration certificate is not yours—it belongs to BRH. If the collaboration is terminated, the registration certificate will revert to BRH.

Want to switch to a different BRH? Then you’ll need to go through the registration process again. During the 6- to 12-month window, your product may be unable to sell. Choosing a BRH is, at its core, choosing who will manage your critical risk exposure. Pick the wrong one, and it’s not just about losing money—it’s about losing your market share.

Brazil’s tax system is renowned for its complex, multi‑layered structure of cascading taxes, where the real challenge lies not in any single tax rate but in the cumulative effect of their combined application.

Taking São Paulo state (ICMS rate of 18%) as an example, assuming II tax rate of 15% and IPI tax rate of 15%, a product with a CIF value of USD 100,000 would incur a post-tax landed cost of approximately USD 176,223, representing a 76.2% increase over the original CIF value.
A more direct example comes from the U.S. Department of Commerce’s International Trade Administration (ITA): when medical devices are imported into Brazil, the combined tax burden and customs clearance costs can increase the final cost by 60% to over 100% compared with the CIF price.
This is not a financial issue that can be optimized later. If you fail to incorporate tax planning into the quoting stage, your profit margin will be eroded outright.

Brazil is the world’s largest Portuguese-speaking country. All product labels, instructions for use (IFU), technical documentation, and communications with ANVISA must be in Brazilian Portuguese.
The difficulty of this matter has actually been greatly underestimated.
Translations involving the principles of precision medicine and regulatory details cannot be handled by standard translation services. What you need is a Portuguese‑speaking professional with a medical background—yet such experts are scarce worldwide.

Many Chinese companies, when expanding overseas, assume that South America equals Spanish—and that English is barely sufficient for communication. Only upon entering Brazil do they realize that, without precise Portuguese translation of their technical advantages, product specifications, and clinical data, these offerings effectively vanish in the eyes of physicians and regulatory authorities.

If Brazil were merely large in scale, that alone would not be enough to make it an “essential choice”; there are three underlying reasons.

ANVISA registration serves as a valuable benchmark across multiple Latin American countries. Establishing a strong foothold in Brazil means that your registrations and brand recognition in Argentina, Chile, Colombia, and other markets will all benefit. In a sense, securing approval in Brazil puts you in a commanding position to dominate the broader Latin American market.

“Wherever there are Chinese enterprises, trouble is bound to follow.”

This is by no means a joke.

In this market, which appears relatively “blue ocean” compared to Southeast Asia and the Middle East, there is a fact that many people overlook:

In the ANVISA 2025 registration database, China has surpassed Brazil itself to become the top country of origin in terms of registration volume. 849 Chinese manufacturers, through 568 Brazilian local entities, completed 3,153 product registrations.

The landscape among the top contenders has already begun to take shape:

Among them, Mindray’s approach is highly instructive.
By establishing its own subsidiary, Mindray do Brasil—where 117 registrations were recorded in 2025, representing a year-on-year growth of 71%—Mindray has achieved comprehensive control over registration, branding, pricing, and after-sales service.

Of course, establishing a wholly owned subsidiary requires annual revenue of at least US$5 million and a development period of 12 to 24 months—but this is the right thing to do, even if it’s challenging.

Brazil’s medical device market currently relies on imports for approximately 60% of its total supply. In high‑tech segments such as advanced imaging equipment and orthopedic implants, import dependence is even higher.
At the same time, domestic companies are gaining ground. Firms such as Wald and Bio-Manguinhos have already demonstrated competitiveness in public procurement and cost‑effective strategies. As Brazil advances policies to promote localized production, the room for a purely import‑based business model is likely to shrink gradually.

Entering now is a race for position.

Entering only after the local supply chain has matured is a race to grab market share.

The two are entirely different in difficulty.

Brazil is not a market suitable for “making quick money.”

Only by adhering to a long-term mindset can one reap the rewards.

It’s precisely because it’s slow that it’s worth a visit.

When a Chinese medical-device company manages to establish a foothold in a market that is entirely unfamiliar—regarding registration, language, taxation, and distribution channels—it gains far more than just a $15.5 billion market share. It acquires the muscle memory of global operations.

From Brazil, Argentina, Colombia, Chile, and Mexico are no longer “uncharted territory” but rather the “next frontier.”

Twenty years ago, a global medical device giant entered the Chinese market.

It took decades to establish registration, build distribution channels, and develop the brand.

Today, the roles are reversed.

Chinese medical device companies should venture onto others’ home turf.

Doing the same thing again.