In her remarks, Yang Xiaofang, Deputy Secretary-General of CAMDI, expressed gratitude for the support and guidance from the Department of Medical Device Regulation, the Center for Food and Drug Inspection, and the Center for Information of NMPA, as well as leaders of provincial medical products administrations. She stated that CAMDI will continue to serve national strategies, industrial development, and regulatory needs as always, work together with all sectors of society to promote the implementation of various regulatory laws and regulations, and play a role in the compliant and orderly development of the industry.
Lu Dawei, Director of the Technical Regulations Department of CAMDI
Wang Shumei from Shanghai United Imaging Healthcare Co., Ltd., Liu Yongying from Edan Instruments, Inc., Zhang Jingxiang from Zhejiang Gongdong Medical Technology Co., Ltd., Wang Chuanyong from Hygea Medical Technology Co., Ltd., Liu Xindong from Shanghai Listent Medical Technology Co., Ltd., Huang Shaojie from Just Medical Devices (Tianjin) Co., Ltd., Li Wei from Guangzhou Wondfo Biotech Co., Ltd., Chen Yikun from Suzhou Becton Dickinson Medical Devices Co., Ltd., and Ouyang Hong from Tianxinfu (Beijing) Medical Appliance Co., Ltd. respectively introduced and exchanged views on key topics such as intelligent manufacturing, finished product inspection and release, and risk-related consultation.
Wang Shumei, Vice President of Shanghai United Imaging Healthcare Co., Ltd.
Liu Yongying, Management Representative of Edan Instruments, Inc.
Zhang Jingxiang, Management Representative of Zhejiang Gongdong Medical Technology Co., Ltd.
Wang Chuanyong, Deputy General Manager of Hygea Medical Technology Co., Ltd.
Liu Xindong, General Manager of Shanghai Listent Medical Technology Co., Ltd.
Huang Shaojie, Management Representative of Just Medical Devices (Tianjin) Co., Ltd.
Li Wei, Vice President of Guangzhou Wondfo Biotech Co., Ltd.
Wang Jun, Management Representative of Suzhou Becton Dickinson Medical Devices Co., Ltd.
Ouyang Hong, General Manager of Tianxinfu (Beijing) Medical Appliance Co., Ltd.
Wei Lan from the Center for Food and Drug Inspection of NMPA presented updates and review points regarding medical device quality system verification (inspection) work.
Wei Lan from the Center for Food and Drug Inspection of NMPA
This conference thoroughly exchanged and studied key content of the Good Manufacturing Practice for Medical Devices (GMP) in system development, intelligent manufacturing, risk management and control, etc., shared excellent enterprise practical experiences with the industry, and consolidated the cornerstone role of the GMP in ensuring product safety and efficacy, which earned recognition and praise from attending leaders and representatives.