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FDA Sees American Dream For Chinese Class 3 Devices

This article was originally published in PharmAsia News

Executive Summary

As China steps up to substitute imported medical devices with domestic products, the U.S. FDA says that it is also likely to see market entry of made in China high-risk medical devices into the United States, according to the agency’s device representative to Beijing. Chinese manufacturers, however, face a number of hurdles before this can become reality.

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