NEWS TRENDS

A government forum held between the United States and China is easing the regulatory burden for U.S. companies that want to import devices into China. The actions announced during the meeting could cut device approval time in half and provide manufacturers with more access to the Chinese market.

This fall, the U.S.-China Joint Commission on Commerce and Trade (JCCT) met to discuss intellectual property, healthcare, agriculture, procurement, and other trade issues. During the session, China's Agency for Quality Supervision, Inspection, and Quarantine and the State Food and Drug Administration announced that they will require only one test, report, fee, and facility inspection for medical devices exported to the country.

“We applaud the Chinese government for taking this important step to reduce redundant regulatory requirements that do nothing to promote the public health of the Chinese people and only serve to delay availability of innovative new products,” says Ralph Ives, AdvaMed's executive vice president of global strategy and analysis. According to the JCCT, the value of device exports to China was about $859 million last year.

China's National Development Reform Commission also said it will listen to feedback from the U.S. government and stakeholders on its revised draft medical device pricing plan and its device procurement policies. Under the proposed pricing policy, the Chinese people have limited access to advanced imported medical devices, according to the JCCT. AdvaMed hopes that a dialogue between the U.S. government and China regarding procurement will enable fairness and transparency on tendering process issues.

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