As China’s medical device manufacturers increasingly turn to markets like North America, intense domestic competition and VBP-driven price pressure squeeze margins. For many, exporting is becoming less about growth and more about survival.
Learn from experts, Senior Auditor, Lane Ji; Director of Medical Device Business, Dr. Yuan Li; Head of Digital Trust, Sandeep Pauddar; and Director of Mexico Sales, Victor Morales.
China's medical device manufacturers are looking outward, including to North America, and the reasons have less to do with opportunism than with survival. Domestic competition is intense, and government-guided procurement mechanisms—including volume-based procurement (VBP)—keep prices low across the home market. For manufacturers trying to protect margin, exporting isn't a growth strategy so much as a necessity. As Senior Auditor, Lane Ji describes it:
"The Chinese government encourages manufacturers to export devices to other countries. China’s market is aggressive, so the competition is severe. A lot of medical device manufacturers face challenges growing their business and growing revenue."
Despite ongoing trade tensions, the United States remains by far the largest destination for these exports. According to Ji’s data, medical device export volume to the US has slowed in recent years, but it still dwarfs every other market at roughly $13.13 billion annually, compared with $3.236 billion for the next-largest market, Japan.
Brazil is emerging as a secondary priority, in his view. The scale of the US gap, though, is the clearest evidence that, whatever the friction, no other market rivals it for Chinese manufacturers.
The conventional assumption is that regulatory approval is the hard part of entering the US market. That's increasingly not the case. Navigating FDA requirements such as QMSR, while not trivial, could be described as relatively straightforward. The real bottleneck has shifted downstream: into procurement.
Hospital purchasing has become more selective, procurement cycles have lengthened, and—notably—artificial intelligence is now cited as a factor making the process harder to navigate, not easier. Getting a certificate no longer guarantees a route to the shelf.
As AI becomes embedded in medical technologies, manufacturers should prepare to demonstrate AI governance alongside cybersecurity.
Dr. Yuan Li, Director of Medical Business at DQS North America, works directly with manufacturers navigating this process. He put it plainly:
This is a theme that auditor Ji returned to repeatedly. In his view, medical device manufacturers overestimate the importance of the approval itself: "Product approval... it’s not the be all and end all. Once you get the certification you also need to know, how do you sell your products in the country?"
e describes market entry as a staged process: local representatives together with distributors and importers first, then offices, and eventually local manufacturing if the business justifies it. Notably, Ji also says this evolution is happening for reasons connected to trade policy, though in his own client experience the visible shift has been toward Southeast Asia rather than Mexico, as a “lot of manufacturers move from China to Vietnam, because of trade wars."
Dr. Li cautiously comments: "Mexico is a manufacturing hub, that doesn't mean that big business sells into Mexico but it is a sizeable market and might be the next Brazil for China, as Mexican consumers begin to look for better-priced options." He also noted early movement worth watching, in that Chinese manufacturers are moving into Mexico to sell locally, but facing different challenges.
On this note, Victor Morales, who manages Mexican business for DQS, says, "Chinese manufacturers coming into Mexico are learning that price alone doesn't win procurement here. Distributors want the same documentation and compliance history that hospitals in the US are starting to ask for."
What ties this together is a shift in what procurement actually expects. Regulatory clearance was once the finish line. Increasingly, it's the entry ticket, and cybersecurity is emerging as one of the new requirements layered on top, particularly for connected and software-driven medical devices.
This signals a need for a structural change for Chinese manufacturers specifically. In short, domestic procurement in China has not historically demanded the same cybersecurity rigor that is now expected by North American, especially US, hospital systems and health networks. Manufacturers who exist for a domestic market are, in effect, being asked to meet a compliance bar they've never had to clear before—at the same moment they're relying on export markets to protect their margins.
"You can easily find manufacturers who have excellent FDA submissions but no cybersecurity documentation to speak of, because it was never asked for at home. That gap doesn't show up until procurement — and by then it's a costly place to discover it," explains cybersecurity expert and Head of Digital Trust at DQS, Sandeep Pauddar.
"ISO 27001 and ISO 42001 were never just checkboxes for AI-enabled or connected devices. Manufacturers need to also see them as the evidence of safe and responsible practices that hospital procurement teams expect to see today, well before a device gets serious consideration."
For medical device manufacturers navigating this, finding a notified body that can partner with them matters more than it used to. A notified body issues the certificate. You also want them to partner alongside you at every stage, so you can face regulatory and cybersecurity scrutiny—and the procurement readiness that follows—with the kind of global consistency that comes from operating as one global organization rather than a loose network of similarly branded local offices.
That consistency is not a minor detail. A manufacturer expanding from China into the US, and potentially into Mexico or Brazil next, needs a partner whose standards and relationships travel with them over borders and seas.
Two ideas, taken together, describe where the North American medical device market is heading:
Procurement expectations now extend beyond regulatory approval to include cybersecurity and, increasingly, AI governance.
Even after approval, medical device manufacturers still need the right market-entry strategy, distribution relationships, and local readiness to actually sell.
Market access can start at certification but must go further. It now means being ready for procurement, for commercialization, and for a long-term presence in the markets that manufacturers are counting on to protect their business.
When you're ready to expand across borders, talk to your global certifications partner, DQS; request a quote or share your certification needs.
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