Innovative Medical Device Go back »

Since 2018, Chinese high-level political figures have promised to ease market access and improve the business environment for FIEs in China on multiple occasions. Under the "innovative medical devices do not need to be listed in their country of origin" and other encouraging policies, for foreign medical device manufacturers and the working group, how to get devices approved quickly so that Chinese people can benefit from world-class innovative medical technology as soon as possible has become a common concern. 

Ms Annie Yin, Chair of Healthcare Equipment Working Group said "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. The Centre provides special approval of innovative medical devices, and also promotes the type of open and fair communication mechanism the CMDE has always pursued, which creates a new way for accelerating the approval of innovative medical devices for listing in China and ultimately faster serving more Chinese patients."

For many years, the working group has maintained a close and friendly partnership with the NMPA and the CMDE. The working group formally submitted materials to the CMDE, recommending the establishment of a review and communication platform for the reporting of innovative medical devices of FIEs. The proposal has received strong support from the CMDE. The working group then conducted a series of feasibility discussions with the NMPA. On 17th May 2019, the Innovation Centre was officially established.

Read more on this advocacy success story, please click here.

For more information on the Healthcare Equipment Working Group, please click here.

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