The 9th China International Medical Device Regulatory Forum Held in Fuzhou

  • 2018-09-18

The 9th China International Medical Device Regulatory Forum hosted by the China Center for Food and Drug International Exchange (CCFDIE) was opened at the Fuzhou Strait International Conference & Exhibition, Fujian Province on September 14, 2018. Xu Jinghe, deputy director of the China Food and Drug Administration (CFDA), attended the forum and delivered a speech. Xu Jinghe emphasized that the new era needs new responsibilities, and the new journey requires new actions. To achieve leap-forward development in the era of globalization, we must eagerly embrace the scientific and technological revolution with enthusiasm, actively promote scientific supervision and comprehensively strengthen international cooperation with perseverance, and work with the international community to build a human health and safety net.

China’s medical device regulators, medical device manufacturers at home and abroad, and medical device regulators, industry experts and representatives from countries and regions such as the United States, Japan, Singapore, etc., have gathered for this forum and shared relevant national and regional medical device regulations and new regulatory measures, development and new progress.

The forum, considering the key points of current medical device supervision, focused on the theme of “strengthening the life cycle management of medical devices, focusing on product quality safety and innovation development”. The headers of the Department of Policy and Regulation, Department of Medical Device Registration, Department of Medical Device Supervision of CFDA, and experts in the fields of medical device standard management, inspection and testing, etc., comprehensively analyzed the medical device regulatory documents in recent years, and introduced in detail the relevant information and latest developments of China’s review and approval system reform, standard management, adverse event monitoring, traceability system construction, industrial development, and international cooperation.

The forum, centering on hot issues of the current medical device industry, included 13 sub-sites such as artificial intelligence and software, clinical evaluation of medical devices, medical device network security, medical device biology evaluation, medical device innovation technology and products. Experts and scholars in the medical device industry at home and abroad communicated with each other and exchanged opinions on the cutting-edge technologies of medical devices.

The China Association for Medical Devices Industry (CAMDI) is one of the co-organizers of the forum and Dr. Fan Xiaodong, vice president of the association, attended the forum and made a report on the “Development Status and Opportunities of China Medical Devices Industry in a New Era”.

Dr. Fan Xiaodong, Vice President of CAMDI, Presided over the “Artificial Intelligence and Software” Chapter and Closing Forum

The forum has strengthened the exchange of international medical device regulations and technical specifications, promoted mutual learning and reference between medical device evaluation departments in various countries, and boosted scientific supervision and international cooperation.