State Food and Drug Administration research team conducts investigation on medical device clinical trial management in Guangdong

From June 5th to 7th, Zhang Hua, deputy director of the Medical Device Registration Management Department of the State Drug Administration, led a team to Guangdong to conduct research on the management of clinical trials of medical devices. Wang Ling, member of the party group and deputy director of the Provincial Drug Administration, accompanied the investigation.

At the symposium, the research team listened to reports on the work of the Guangdong Provincial Drug Administration and the Evaluation and Certification Center (Drug Inspection Center) of the Guangdong Provincial Drug Administration. Representatives of 10 medical device clinical trial institutions including the Provincial Medical Device Management Society, the First Affiliated Hospital of Sun Yat-sen University, and 6 sponsors including Shenzhen Mindray Biomedical Electronics Co., Ltd. made exchanges and speeches around the research theme in turn. The research team also exchanged in-depth views with the participants on the key items of the “Inspection Points and Judgment Principles of Medical Device Clinical Trial Institutions (Draft for Comment)” and the implementation of the “Quality Management Standards for Medical Device Clinical Trials”.

Relevant comrades from the Administrative Licensing Division and the Evaluation and Certification Center of the Guangdong Provincial Drug Administration participated in the discussion. Comrades in charge of relevant work of the Sichuan Provincial Drug Administration and relevant experts were invited to participate in this research activity.

The research team also went to South China University of Technology, Guangzhou International Biological Island (China-Israel Cooperation Zone), and the First Affiliated Hospital of Sun Yat-sen University to conduct on-site investigations. (Contributed by the Administrative Licensing Office of the Provincial Bureau/Picture)