On the evening of June 15, 2020, the Asia Pacific Economic Cooperation (APEC) Regulatory Coordination Committee (RHSC) unanimously approved the APEC Center of Excellence (CoE) in medical devices regulatory science application from Sichuan University (SCU) in the global teleconference, which is the first CoE in medical devices regulatory science in China. A total of 78 experts and officials from 18 APEC economies, 15 universities or research institutions, 7 global pharmaceutical industry organizations and 5 international organizations such as WHO, ICH and IMDRF attended the meeting. At the meeting, the chairman of RHSC introduced the summary report on the CoE pilot workshop hosted by SCU. It was pointed out that SCU has completed the amazing pilot workshop, and all indicators have created the records of RHSC. It took less than one year from the application to the approval.
In April 2019, the first research base of regulatory science for medical devices ofNational Medical Products Administration (NMPA)was established in Sichuan University, and one of the main objectives of the base is consistent with that of the APEC CoE. Considering the high international reputation and academic influence of SCU in the medical devices field, NMPA decided to support Institute of Regulatory Science for Medical Devices (RSMD) of SCU to apply for APEC CoE in medical devices. In August 2019, at the third APEC executive meeting held in Chile, academician Zhang Xingdong of SCU led the team to attend the meeting and formally submitted an CoE application which was highly praised and was approved for pilot. In December 2019, the pilot workshop in theme of medical devices regulatory science was successfully held. About 140 delegates from 17 economies attended the workshop. The training has strengthened delegates’ understanding of the coordination of medical device regulation and the global integration of medical devices. The CoE pilot workshop has been highly praised by APEC participating economies on the global conference.