CAMDI Attending 14th Meeting of International Medical Device Regulators Forum Management Council

  • 2018-09-25

The public opening meeting of the 14th Meeting of the International Medical Device Regulators Forum Management Council was opened on September 18th in Beijing. Xu Jinghe, deputy director of the China Food and Drug Administration (CFDA), attended the meeting and delivered a speech.

In his opening speech, Deputy Director Xu Jinghe pointed out that in recent years, China has vigorously implemented the strategy of innovation-driven development, and the medical device industry has been experiencing unprecedented growth. As a major producer and import & export base of medical devices in the world, China’s huge demand of the medical device market attracts excellent medical device companies from all over the world. Director Xu also stated that CFDA is committed to comprehensively promoting the construction of medical device regulations, continuously deepening the reform of the medical device review and approval system, and continuing to strengthen the post-marketing supervision of medical devices. China’s medical device supervision will continue to enhance their capabilities, and the quality and safety of medical devices have been continuously improved as a result. He finally stressed that China will further deepen the reform of medical device supervision, strive to promote modernization with internationalization, actively participate in international exchanges and cooperation in medical device supervision, and promote the coordination and consistency of international medical device regulations to contribute wisdom and strength to public health and life safety.

More than 300 representatives including full members of IMDRF Management Committee, official observers, invited observers, and representatives from regional coordination organizations, industry associations, medical device enterprises, and teaching & research institutions attended the meeting. The China Association for Medical Devices Industry ((hereinafter referred to as the Association) is one of the co-organizers of the forum and Dr. Yang Xiaofang, deputy secretary general of the association, attended the forum and made a report on the “Development Status of China Medical Devices Industry”.

The all-day open meeting on September 18 consists 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. Then, the seven working groups currently organized by IMDRF introduced the progress and results of their work in turn. In the afternoon’s third session, a seminar on “Robotic Medical Devices” was held. Experts and scholars from China’s medical device regulators, scientific research institutions, and medical institutions and enterprises were invited to share their insight into robotic medical devices and exchanged ideas with representatives. In the fourth session, the representatives from the China Association for Medical Devices Industry (CAMDI), Global Diagnostic Imaging, Healthcare IT, and Radiation Therapy Trade Association (DITTA) and Global Medical Technology Alliance (GMTA), APEC Life Sciences Innovation Forum - Regulatory Harmonization Steering Committee (APEC LSIF-RHSC), Asian Harmonization Working Party (AHWP), and Pan American Health Organization (PAHO), the official observer of the World Health Organization (WHO), and the invited observer of the Hong Kong Special Administrative Region (HKSAR) reported on their work related to medical devices.

According to the meeting schedule, the private session the IMDRF Management Committee will be held from September 19th to 20th, and Yang Xiaofang (deputy secretary general of the association) was invited to participate in the session.