By Stewart Eisenhart, Emergo Group
EMERGO SUMMARY OF KEY POINTS:
- The China Food and Drug Administration (CFDA) has expanded the number of medical devices that do not require clinical trials for approval in the country.
- The new CFDA lists include 276 Class II devices and 92 Class III devices exempt from CFDA clinical trial requirements.
- The new exemptions came into force in late September 2016.
China’s medical device market regulator, the China Food and Drug Administration (CFDA), has published new lists of medical devices exempt from clinical trial requirements in the country.
According to a CFDA announcement (link in Chinese), the “second batch” of exemptions includes various Class II and Class III devices. There are now 276 Class II devices qualifying for exemption, including assisted reproduction products, gastric bypass surgery devices and interventional devices; 92 Class III devices now qualify as well, including blood processing and bypass equipment. These devices no longer must undergo clinical trials in order to obtain market authorization in China.
The latest exemptions took effect September 30, 2016.
To learn more about Chinese medical device registration and clinical trial requirements, download our regulatory process chart.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
