China agrees to address device industry clinical trial requirements in bilateral agreement with U.S.

The medical device industry was featured prominently in an agreement reached at the 25th U.S.-China Joint Commission on Commerce and Trade meeting. While China's move toward easing imports of U.S. medical devices into the country--worth about $2.7 billion in 2013--has already been documented, Beijing's commitment to address the medical device industry's growing concerns about the country's clinical trial requirements could ultimately be more significant.

AdvaMed sources told FierceMedicalDevices that the top concern facing American device companies in China is an increase in the number of required clinical trials, especially those that must be conducted in China. To that end, China said it will reduce the number of required trials, and that fewer the required trials will have to take place in China.

"In accordance with the Regulations on Supervisory Management of Medical Devices, China will, to facilitate practical regulatory needs, further accelerate the expansion and adjustment of clinical trial product exemption catalogues; expand the scope of medical devices that can be exempted from conducting clinical trials in China; reduce the number of medical device clinical trials and improve the efficiency of bringing imported medical devices to the Chinese market," says a fact sheet from the Office of the United States Trade Representative under the section entitled "Medical Devices and Pharmaceuticals Market Access."

The promise about "clinical trial product exemption catalogues" is important because companies are anxiously awaiting the list of devices that are exempt from the clinical trial requirements, and trying hard to convince China FDA (CFDA) to include their product on the list, according to AdvaMed sources.

China had previously taken steps to liberalize the trade of medical devices by, for example, agreeing with the U.S. in principle on the terms of World Trade Organization's tariff-cutting Information Technology Agreement that includes devices, though a separate disagreement between China and South Korea over flat screen TVs has blocked implementation. In contrast, the country had been largely silent about the clinical trial requirements facing companies in its pharma and medical device industries.

Interestingly enough, the medical device industry is one of only a handful of industries that achieved sector-specific agreements--others include fisheries and legal services--according to the fact sheet. And it is surprising to see such specific and pointed promises relevant to the medical device industry in an agreement covering trade between the world's two largest economies.

That shows the importance of the industry to both economies and their governments. Indeed, Beijing has made growing the local medical device industry one of its priorities, and has a goal of creating 10 med tech breadwinners worth 5 billion yuan ($820 million) apiece by 2020. Recently, the Chinese government has been making sounds through avenues like the state-controlled media indicating that it would like hospitals to buy more Chinese-made medical equipment.

The U.S. industry hopes agreements like this one can help restrain those protectionist impulses, whether in the form of trade barriers or higher regulatory requirements for foreign companies.

- here's the government fact sheet
- here's AdvaMed's statement in support of the deal

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