As innovative devices and first-of-kind products enter China market, NMPA seeks to strengthen the clinical trial approval requirements for certain devices. Not all of them require NMPA clinical approval to begin clinical trial but for some there is an extra step. NMPA published the draft version of Catalog of Class III Medical Devices Requiring Clinical Trial Approval on June 25, 2020. Feedbacks need to be submitted by July 31, 2020.
NMPA initially implemented the clinical approval catalog in August 2014 when, for example, 3D orthopedic devices were on the list. Several changes have been made after the version. The latest one was issued in December 2019 where the following devices were included. Now they are removed from the 2020 draft version:
For our comments on 2019 catalog, please click HERE.
On another positive side for manufacturers, overseas clinical data is applicable for the six categories of devices, according to the Guideline for Acceptance of Overseas Clinical Trial Data of Medical Devices issued on January 11, 2018.