The Experts Preparatory Meeting of Clinical Trial Branch of the CAMDI and the Reform and Innovation Seminar on Medical Devices Clinical Trial Review and Approval Successfully Held in Beijing

  • 2018-03-13
On March 10, 2018, the First Expert Committee Preparatory Meeting organized by the preparatory group of the clinical trial branch of the CAMDI (hereinafter referred to as the "Clinical Trial Branch") and the Innovation Seminar on Medical Devices Clinical Trial Review and Approval were successfully held in the Zhongguancun Medical Translation Center.

Figure 1: seminar highlights

The attendees were medical devices clinical trial experts including Wang Huanling, a director of Peking Union Hospital (PUH), Shu Chang, a director of Fuwai Hospital Chinese Academy of Medical Sciences (FHCAMS) and Chen-Xi Ouyang, a deputy director of FHCAMS, Li Wei, a director of National Center for Cardiovascular Disease (NCCD), Chen Zhigang, a director of Beijing Jishuitan Hospital (BJH), Jiang Haihong, a director of Shanghai University Of Medicine & Health Sciences, Yu Guoning, a director of Liaoning Provincial People's Hospital, Wu Wei, an associate professor of Beijing Anzhen Hospital, Capital Medical University, Liu Shenglin, a director of Union Hospital, Tongji Medical College, Huazhong University of Science & Technology, Lu Shousi, a director of Beijing Bo'ai Hospital, and Chu Zhaowei, an expert of Natonal Research Center for Rehabilitation Technical Aids. Jiang Feng, the Standing Vice-Chairman of the CAMDI and Xu Shan, secretary general of the CAMDI attended the seminar which was presided over by Sun Jingsheng, leader of the preparatory group. And all members of the preparatory group attended the meeting.

Figure 2: photographs of participating experts

In the seminar, vice-chairman Jiang Feng made a keynote speech. He emphasized the importance of the establishment of a clinical trial branch, and proposed the main development directions for the branch to serve the government and the industry. At the same time, he introduced the purpose of the CAMDI and related work to the participating experts.

Figure 3: Jiang Feng, Standing Vice-Chairman of the CAMDI making a speech.

The experts participating in the seminar reached a consensus that there was a pressing need to establish a clinical trial branch according to Opinions on Deepening the Reform of the Evaluation and Approval Systems and Encouraging Innovation on Drugs and Medical Devices issued by the General Office of the CPC Central Committee and the General Office of the State Council. The establishment of the Branch will help China Food and Drug Administration (CFDA) do a better job in carrying out Measures for Conditions and Record Management of Medical Device Clinical Trial Institutions (hereinafter referred to as "the Record Measures”) and provide technical support to the industry in implementing the "Record Measures.” It is of great significance to the establishment of medical device clinical trial institutions and the development of the industry.

Figure 4: experts at the preparatory meeting giving their opinions and advice
Figure 5: a photo of members of the preparatory group of the clinical trials branch of CAMDI

The meeting marked that the preparatory work for the clinical trials branch has officially started, and a preparatory meeting for representatives of medical device companies and research institutions will be held in the near future. The progress of the work of the branch will start to be published on the website soon.