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.