The China Food and Drug Administration released the draft “List of Clinical Trial Exempt Devices – Second Listing” for public comment on May 20, 2016. This draft indicates CFDA’s increased governance on a wider range of medical devices and its assessment on the clinical trial requirements and expanded the list of clinical trial exempt devices.
This draft Listing comprises of 35 product groups, of which the Class II list has 32 product groups representing 259 product names, and the Class III list has 13 product groups representing 93 product names.
List of the Class II and Class III Clinical Trial Exempt Devices
Final as per 30 September 2016