With investment from the local distributor and a careful strategy, the Brazilian manufacturer enters the restricted Chinese neurosurgery market.
China, with over 1.4 billion inhabitants and a healthcare system that combines near-universal public coverage with a growing private sector, is today one of the most complex and promising markets in the world. The country values both modern and traditional medicine, has strict regulatory processes, and a business culture that demands time, trust, and adaptation.
In this challenging scenario, Hpbio, a Brazilian manufacturer of medical devices associated with ABIMO, achieved a historic milestone by obtaining local registration for its programmable valve for use in neurosurgery, becoming the fifth option available to Chinese doctors.
The journey to this approval was long. Interest arose six years ago when a Chinese distributor was looking for highly specialized products with low availability in the global market. Hpbio’s programmable valve, which has similar products manufactured by only four other manufacturers worldwide, caught their attention.
The device – made of polysulfone with a silicone coating and titanium connectors – was designed to provide precise control and ease of pressure adjustment, which can be done by a non-invasive and painless magnetic device for the patient, in addition to safety against reprogramming with a double locking system.
Considering the quality and innovation of the product, the distributor decided to invest directly in the registration process, bearing the cost of revalidating all tests already carried out in Brazil, now in Chinese laboratories, a local regulatory requirement. The pandemic delayed the plans, and what could have taken three years stretched to five. Authorization was only granted in early 2025, after an on-site inspection by the Chinese government at the Hpbio factory in São Paulo (SP).
“It was an extremely complex process, but necessary to open the doors to the Chinese market. We are now the fifth alternative for programmable valves in the country, which puts us in a position of great responsibility,” says Flávia Rodrigues Carvalho, International Business Specialist at Hpbio.
Aligned Strategy
The company adopted strategic measures to protect its innovation, such as registering the valve patent in China even before starting negotiations. In addition, it included unprecedented clauses in the contract with the distributor, requiring a Chinese professional to come to Brazil for in-person training and participation in surgeries, becoming a product specialist. “It was the first time we included this requirement. We understand that the challenges of the Chinese market are more complex, and we wanted to ensure that the product had adequate technical support,” explains Flávia. Cultural and linguistic barriers were also significant. “I had a lot of difficulty being understood. I even took a course on Chinese culture to better understand how the local mentality works. I learned to use words, examples, and metaphors that are more familiar to them, which helped a lot,” she comments.
Hpbio’s achievement symbolizes not only the company’s expansion but also the strength of the national medical device industry in the face of global manufacturers. At a time when Brazilian exporters are seeking to diversify markets in the face of the high tariffs imposed by the United States, the presence in the Asian giant reinforces the potential of #healthcaremadeinbrazil to compete globally with innovation, quality, and resilience.
Source: Abimo – 12/2025