The first “IEC International Medical Equipment Standards Forum” was successfully held in Shanghai on the afternoon of May 16, 2015, during the 73rd China International Medical Equipment Fair and the 20th International Component Manufacturing & Design Show. The organizers of this forum were International Electrotechnical Commission (IEC) TC 62: Electrical equipment in medical practice, China Standard Committee for Medical Electrical Equipment, and China Standard Committee for X-Ray Medical Devices and Tools. The co-organizers were ReedSinoPharm China, Liaoning Medical Device Test Institute, and Shanghai Testing and Inspection Institute for Medical Devices.
Mr. Yan Kang, chairman of IEC TC 62B, chaired this forum. Many officials attended this forum, including Ms. Xin Li from the Standardization Administration of China (SAC), Ms. Jingli Li and Mr. Xinhua Yu from the Center for Medical Device Standardization Administration of CFDA, Mr. Rongliang Chen and Mr. Jianjun Wang from Liaoning Medical Device Test Institute, Mr. Jiahua Huang and Mr. Jun He from Shanghai Testing and Inspection Institute for Medical Devices,
Eight speakers delivered excellent speeches at the forum. They were Ms. Xin Liu, deputy director at International Cooperation Department of the Standardization Administration of China, Ms. Jingli Li, director of the Center for Medical Device Standardization Administration, CFDA, Mr. Dennis Chew, director of IEC Asia-Pacific Center, Mr. Zhuohui Sun, manager of Regulatory Affairs at GE Healthcare China, Mr. Norbert Bischof, secretary of IEC TC 62 and TC 62B, Mr. Jiahua Huang, director of the Shanghai Testing and Inspection Institute for Medical Devices, Mr. Gurvinder S. Virk, convener of ISO&IEC Joint Team for Medical Robots, and Mr. Jianjun Wang, deputy director of Liaoning Medical Device Test Institute.
The forum was focused on international medical equipment standards, the mechanism and strategy for enterprises participating in the international standardization, as well as the challenges and impact of novel technology and IEC 60601 3rd edition to the standards for medical equipment. The wonderful reports of invited speakers received high praises from attendees.
China’s medical device industry has been increasing rapidly in recent years. The Chinese government and enterprises are increasingly paying attention to and placing emphasis on participation in the international standardization. This forum made important contributions to promoting substantive participation of Chinese medical equipment enterprises in international standardization, and to strengthening Chinese and foreign standardization technical exchanges. Moreover, it has played an active role in better fulfilling the duties of China as an IEC member and increasing Chinese influence in IEC.