Symposium on Revision of Medical Device Management Quality Management Standards Held in Beijing

, a symposium on the revision of the "Medical Device Management Quality Management Standards" was held in Beijing. China Drug Supervision and Management Research Association, China Medical Device Industry Association, China Pharmaceutical Business Association, China Federation of Logistics and Purchasing Medical Device Supply Chain Branch and representatives of a number of medical device business enterprises attended the forum. Xu Jinghe, member of the party group and deputy director of the State Food and Drug Administration, attended the forum.

, the participants made positive comments on the draft of the revised draft. At the same time, they seriously discussed and exchanged views on how to adapt to the new business type and new model in the field of medical device operation in recent years, effectively solve the new situation and new problems, and improve the modernization level of operation and management.

Xu Jinghe emphasized that the "Medical Device Management Quality Management Standard" is an important normative document to regulate the business behavior of medical device companies and promote the high-quality development of the industry. The revision of the "Specifications" must conscientiously implement the "four most stringent" requirements of General Secretary Jinping on drug safety, and use a more scientific and complete system design to promote the comprehensive prevention and control of risks, the comprehensive implementation of responsibilities, the comprehensive improvement of the system and capabilities The overall improvement of the company's management level to effectively ensure product quality and safety; it is necessary to deeply grasp the industrial characteristics and risk characteristics of the medical device business link, adhere to the problem orientation, improve the system and operating mechanism, and further promote the high-quality development of the industry; adhere to the principles of scientific legislation and democratic legislation, pay attention to the unity and coordination of the legal system of laws and regulations, and further enhance the scientific and modern level of the legal system of medical devices.