On July 19th, the “Fifth Symposium on scientific supervision and development of medical devices” hosted by China Health-Media Group, Ltd., Sino-Alliance Events, a wholly-owned subsidiary of China Health Media Group, and Weihai Food and Drug Administration was held in Weihai. The seminar conducted in-depth discussions on deepening the reform of medical device review and approval system, implementing the main responsibility of enterprises, standardizing the management of new medical device activities, and the healthy development of the service industry by keynote speeches such as policy interpretation, regulatory practice, enterprise self-discipline, as well as enterprise executive forums, forums on medical device registration and regulatory construction, and actively explored innovative ways of scientific supervision of medical devices.The forum, at the time of public consultation of the establishment of China Drug Administration and the amendments to the Regulation on the Supervision and Administration of Medical Devices Regulations on the Supervision and Administration of Medical Devices (Draft for Review), aims to build a platform for government and enterprises to promote the industry’s in-depth understanding of national medical device regulatory polices, fully listens to the voice of enterprises and further gather the reform consensus. It was also an important measure for China Health-Media Group, Ltd. to take advantage of the think tanks and serve regulatory upgrades and industrial development.
In the keynote speech session, Liu Pei, the former head of the Legal Department of China Food and Drug Administration, Wang Zexiong, Director of the Department of Medical Device Registration, and Kong Fanpu, Director of the Department of Medical Device Supervision introduced recent work progress and key work in 2018.
In addition to the policy interpretation by the China Drug Administration, representatives of local food and drug regulatory authorities and medical device companies also shared their work experience. Liao Fayin, Deputy Director of Shandong Food and Drug Administration, Shen Xiaojie, Deputy Director of Jiangsu Changzhou Food and Drug Administration, and Chen Bin, Director of Zhejiang Tonglu County Market Supervision Bureau, introduced the experience and practices of local transformation, scientific supervision and innovative services. Yu Qingming, Chairman of China National Medical Device Co., Ltd., Yang Zhaoxu, Vice President of Shinva Medical Instrument Co., Ltd., and Zhang Huawei, President of WEGO shared their useful attempts in implementing the main responsibility of enterprises and ensuring product quality and safety.
During the seminar, 26 well-known medical device companies jointly issued the Proposal for Implementing Enterprise Main Responsibility in the Medical Device Industry to actively implement the main responsibility of enterprises.
The meeting was presided over by Wu Shaozhen, Chairman of China Health-Media Group, Ltd., and Ye Liyun, Vice Mayor of Weihai Municipal People’s Government, gave a welcome speech. Nearly 80 representatives from the relevant departments of the former China Food and Drug Administration, some provincial, municipal, county-level food and drug regulatory authorities, medical device companies and industry associations attended the meeting. The representatives of China Association for Medical Devices Industry, a support unit of the conference attended the conference.