In the morning of March 21, 2018, Jiao Hong, Deputy Director of China Food and Drug Administration (CFDA), attended the 13th Open Meeting of International Medical Device Regulators Forum (IMDRF) and delivered a speech. And Xu Kunlin, Deputy Mayor of Shanghai, also attended the meeting and delivered a speech.
The opening meeting consisted of four sessions. In the first session, the representatives of medical device regulators from 10 full members of IMDRF Management Committee, including China, the United States, the European Union, Japan, Australia, Canada, Brazil, Russia, Singapore and South Korea, briefed the attendees on their domestic development of medical device regulations. In the second session, the 7 working groups of IMDRF made presentations on the progress and results of their ongoing projects. In the afternoon’s third session, a seminar on “AI Medical Devices” was held. Five experts and scholars from China’s medical device regulators, scientific research institutions and enterprises were invited to share their insight into AI medical devices and discussed the related issues with representatives. In the fourth session, the representatives from three Chinese and foreign industry associations including the China Association for Medical Devices Industry (CAMDI), Global Diagnostic Imaging, Healthcare IT, and Radiation Therapy Trade Association (DITTA) and Global Medical Technology Alliance, World Health Organization (WHO), the official observer of IMDRF, SFDA of Saudi Arabia, the invited observer, and three regional coordination organizations including Asia-Pacific Economic Cooperation, Life Science Innovation Forum, Regulatory Harmonization Steering Committee (APEC LSIF-RHSC), Asian Harmonization Working Part (AHWP) and Pan American Health Organization (PAHO) reported on their work related to medical devices.
The IMDRF open meeting is a significant part of the IMDRF Management Committee meetings. Lasting for 1 day, it aims to provide a platform to bridge the entire medical devices industry and the regulators. The opening meeting was undertaken by CFDA. 300-odd representatives from the full members of IMDRF Management Committee, official observer, invited observer, regional coordination organizations, industry associations, medical device enterprises, and teaching & research institutions attended the meeting. Officers from relevant departments, directly-controlled organs of CFDA, and provincial and municipal food and drug administrations also participated in the meeting.
The opening meeting consisted of four sessions. In the first session, the representatives of medical device regulators from 10 full members of IMDRF Management Committee, including China, the United States, the European Union, Japan, Australia, Canada, Brazil, Russia, Singapore and South Korea, briefed the attendees on their domestic development of medical device regulations. In the second session, the 7 working groups of IMDRF made presentations on the progress and results of their ongoing projects. In the afternoon’s third session, a seminar on “AI Medical Devices” was held. Five experts and scholars from China’s medical device regulators, scientific research institutions and enterprises were invited to share their insight into AI medical devices and discussed the related issues with representatives. In the fourth session, the representatives from three Chinese and foreign industry associations including the China Association for Medical Devices Industry (CAMDI), Global Diagnostic Imaging, Healthcare IT, and Radiation Therapy Trade Association (DITTA) and Global Medical Technology Alliance, World Health Organization (WHO), the official observer of IMDRF, SFDA of Saudi Arabia, the invited observer, and three regional coordination organizations including Asia-Pacific Economic Cooperation, Life Science Innovation Forum, Regulatory Harmonization Steering Committee (APEC LSIF-RHSC), Asian Harmonization Working Part (AHWP) and Pan American Health Organization (PAHO) reported on their work related to medical devices.
The IMDRF open meeting is a significant part of the IMDRF Management Committee meetings. Lasting for 1 day, it aims to provide a platform to bridge the entire medical devices industry and the regulators. The opening meeting was undertaken by CFDA. 300-odd representatives from the full members of IMDRF Management Committee, official observer, invited observer, regional coordination organizations, industry associations, medical device enterprises, and teaching & research institutions attended the meeting. Officers from relevant departments, directly-controlled organs of CFDA, and provincial and municipal food and drug administrations also participated in the meeting.
