‘Green Channel’ Shortens the Approval Time of Most Advanced Medical Devices

Background

The quantity and time of approval for listing for innovative medical devices in China lags significantly behind developed countries such as Europe, America and Japan. Although the NMPA opened a special approval channel for innovative medical devices in 2014, import enterprises are still unable to participate in expert review through the same process as domestic companies. This, to a certain extent, has affected the import enterprise’ qualification application for innovative medical devices. Based on this background, after repeated negotiation and careful deployment between the European Chamber and the Centre for Medical Device Evaluation (CMDE), the European Chamber Innovation Centre (Innovation Centre) was launched in May 2019.

Result

• For applications of innovative medical devices submitted by foreign companies, the CMDE can conduct remote review through the video platform of the European Chamber.  
• The European Chamber platform is the only platform for foreign products, among all Chambers/industry associations.
• “The European Chamber Innovation Centre”,  first successfully applied in medical device sector, could be expanded to other sectors that require technical review.

Impact

This opportunity to get the ‘green channel’ will shorten the approval time of most advanced medical devices.