Shanghai — China's medical device market is booming, but regulatory walls and concerns about intellectual property are keeping foreign processors largely on the bottom tier of the supply chain.
One complaint frequently heard among global plastics companies at the recent Medtec China trade show in Shanghai was that onerous standards — often stiffer than those in Europe and North America — effectively keep components makers out of the lucrative final-assembly and OEM business.
"Some products that don't require a clean room to be made in America require a clean room in China," said J.Y. Goh, marketing manager at Singapore-based injection molder Univac Precision Products Co. Ltd.'s Suzhou plant.
Catheter maker Optinova AB must deal with extremely high tolerances demanded by Chinese regulators.
"They are higher than in Europe. Sometimes they aren't really relevant," said Asa Mattson, director of consumer care at the Aland Islands, Finland-based company.
Vaguely worded and rapidly implemented regulations were a bugbear cited by Michael Lou, sales and marketing director at the Suzhou factory of Wayne, Pa.-based Tekni-Plex.
Noting the particularly strict standards on phthalates, Lou observed dryly: "If everyone complied with this regulation, every factory must be shut down."
While U.S. regulations typically distinguish between a medical device's design and its manufacture, Chinese law leaves manufacturers legally exposed for a poorly designed product.
For foreign-owned processors, the usual tactic is to ship individual components to a manufacturer, typically a major multinational. This customer then assembles the final product and submits to the Chinese Food and Drug Administration for approval or exports it.