National Experience Exchange Meeting of GMP for Medical Devices Convened in Beijing
On November 8, 2019, the National Experience Exchange Meeting of GMP for Medical Devices was convened in Beijing. It was sponsored by the China Association for Medical Devices Industry (CAMDI) and guided by the Department of Medical Device Regulation of National Medical Products Administration (NMPA). Xu Jinghe, deputy commissioner of NMPA, Wang Zhexiong, director of the Department of Medical Device Regulation of NMPA, Wang Shuicai, deputy director of the Department of Medical Device Regulation of NMPA, Zhang Qi, deputy director of the Department of Medical Device Regulation of NMPA, Shi Lei, deputy director of Center for Food and Drug Inspection of NMPA, Cao Guofang, deputy director of Center for Drug Reevaluation of NMPA (National Center for ADR Monitoring), Dr. Bill Sutton, FDA office in Beijing, China, Ms. Yuan Jie, European Union Chamber of Commerce in China (EUCCC), and heads and leaders of provincial and municipal drug regulatory systems, as well as representatives from one hundred enterprises across China attended this meeting. Zhao Yixin, president of CAMDI, Jiang Feng, standing vice president of CAMDI, and Fan Xiaodong, a vice president of CAMDI also attended this meeting. Mr. Zhao Yixin addressed the meeting and presided over the session in the afternoon.
This meeting, based on the full implementation of the Regulation on the Supervision and Administration of Medical Devices and the GMP for Medical Devices, aims to further advance the medical devices manufacturers in constant upgrade of quality management system (QMS) and improvement of ability and level concerning quality management. A total of ten representative enterprises, including Lepu Medical Technology (Beijing) Co., Ltd., Neusoft Medical Systems Co., Ltd., MicroPort Scientific Corporation and Shenzhen Mindray Bio-Medical Electronics Co., Ltd., presented work reports respectively with regard to five modules – how to strengthen quality control, how to monitor adverse events and manage post-market risk, approaches of management representatives to fulfill their duties, how to take CAPA and verify the effectiveness of the measures, and how to accomplish management review, internal audit and self-inspection report as required.
In this meeting, Mr. Xu Jinghe, Mr. Wang Zhexiong and Mr. Zhang Qi delivered keynote speeches respectively.