China Updates List of Local Clinical Trial Exempt Devices

On September 30, 2016, the China Food and Drug Administration (CFDA) published an update to “Exemption list of Class II and Class III devices for local clinical study”. Following the May 2016 release of the original list, there are now a total of 276 Class II devices and 92 Class III devices exempt from local clinical trials. Devices covered on the list include plastic surgery instruments, assisted reproduction products, dental equipment and devices, and blood processing and analyzing equipment. This list aims to improve the Chinese healthcare system by reducing time and costs spent by foreign medical device companies registering their products in China.