On the first day of CMEF (Autumn), the “First Medical Device Registration Verification Points and Post-market Regulation Summit”, co-sponsored by China Association for Medical Devices Industry (CAMDI), Reed Sinopharm Exhibitions (RSE) and Tacro Technology Co., Ltd., was held. Six industry experts were invited to share their experience in medical device compliance in the field, with nearly 200 spectators attracted, making it the most popular forum on the first day of CMEF.
Dr. Fan Xiaodong, vice-chairman of CAMDI and director of China Medical Device Information Periodical Office addressed.
Yang Guang, deputy director of Administrative Licensing Office of Guangdong Food and Drug Administration shared his working experience in system verification in terms of the general information, regulatory requirement, FAQs and perfect suggestions, and the FAQs aroused sympathy of the enterprises, and he emphasized that it is the only way out for enterprise quality to enhance prevention and deepen vigilance and regulation.
Jiang Haihong, director of Medical Device Supervision, Shanghai University of Medicine & Health Sciences, analyzed the legal liability for adverse event and recall of medical devices in the field, emphasizing that the manufacturers of the medical devices are the primary subject of legal responsibility.
Li Yuan, technical manager of TACRO, dissected the existing problems of the manufacturers of medical devices concerning production management, facilities and quality control based on the unannounced inspection result of the medical devices, and brought forward constructive suggestions.
Dr. Xu Peng, deputy general manager of TACRO, elaborated the main problems and countermeasures for the clinical verification of medical devices from the aspect of regulation dynamics, problem analysis, verification content and countermeasures, emphasized the clinical data traceability and operation normalization.
Ji Lifang, director of medical devices of BSI China, explained the risk management requirement and the application of technical tools in the medical devices field, emphasizing that the application of the risk management requirement of medical devices and selection of analysis tool is the core of risk control, and calling for the enterprises to integrate the risk management consciousness to daily work.
IDC China managing director shared the development of new product strategy for medical devices and the control of innovation process, and the integration of human factors engineering, regulations, patent and medical devices design & development to strengthen the systemic development strategy gained identification of the participating enterprises.