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FDA Expects Class III Device Imports From China

As Chinese companies take market share from multinationals in China in some high-risk implantable device categories, FDA's device representative in Beijing says the agency expects to see made-in-China class III devices enter the U.S. Chinese manufacturers, however, face a number of hurdles before this can become reality.

About 4,000 China-based medical device makers are registered with FDA. Right now, these companies export lower-risk class I and II devices to the U.S. market. But FDA expects class III devices from China on the U.S. market, according to William Sutton, deputy director of industry and consumer education at CDRH.

Currently serving on a detail assignment as an International Program and Policy Analyst for Medical Devices in China, Sutton went to Beijing eight weeks ago

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