The Center for Medical Device Evaluation (CDME) of National Medical Products Administration (NMPA) has recognized the positive performance of the fast-track approval process for the registration of medical devices in 2020. Prior to Coronavirus the pathway was seldom used, but 2020 saw higher volumes and its success has encouraged the CDME to implement a smart review process to further streamline and objectivize the registration process.
On December 18, 2020, the CMDE published a short review about the control work deployed to combat the coronavirus outbreak and reported a total of 76 medical devices that were urgently approved to enter the China market. The CMDE confirmed that the fast-track approval process was the key to help control the pandemic situation.
Considering the events and regulatory decisions made in 2020, the CDME announced their plan to establish a smart review process for the registration of medical devices in China, in order to enable automated task distribution and eliminate the possibilities of personal influence or conflict of interest upon the official decision of granting approvals.
Stay tuned for more details about the implementation of the smart review process in China.
By Jacky Li. Contact Cisema if you would like to learn more.
