National Medical Device Production Quality Management Specification Experience Exchange Conference Convened

On November 8, a national experience exchange meeting on medical device production quality management specifications was held in Beijing. The meeting was guided by the Medical Device Supervision Department of the National Medical Products Administration and hosted by the China Medical Device Industry Association. The purpose of this meeting was to promote the overall improvement of the medical device production quality management level across the industry and to promote the high-quality development of China's medical device industry through the exchange of advanced experiences from enterprises and the exemplary role of typical enterprises. Xu Jinghe, vice director of the National Medical Products Administration, attended the meeting.

In recent years, with the continuous promotion of medical device production quality management specifications, the medical device industry has made certain achievements in the implementation of these specifications. The overall quality and safety management level of the industry has continuously improved, and the safety and public satisfaction of products have steadily increased. A number of high-quality Brands and enterprises with excellent quality management have gradually emerged. However, judging from the feedback from regulatory inspections, there are still problems of varying degrees in the implementation of the specifications.

At the meeting, representatives from 10 medical device manufacturing enterprises—Lepu (Beijing) Medical Equipment Co., Ltd., Dongsoft Medical Systems Co., Ltd., Shanghai MicroPort Medical (Group) Co., Ltd., Shanghai Zhijiang Biotechnology Co., Ltd., Suzhou Kangli Orthopedic Instrument Co., Ltd., Aikon Bio (Hangzhou) Co., Ltd., Yantai Zhenghai Biotechnology Co., Ltd., Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Chongqing Jinshan Science & Technology (Group) Co., Ltd., and Abbott Trading (Shanghai) Co., Ltd.—exchanged views on multiple topics, including the performance of duties by management representatives, strengthening quality control, and managing medical device adverse events and post-market risk management. 100 enterprises with advanced experience in implementing medical device production quality management specifications across the country conducted written exchanges. Relevant personnel from the Medical Device Supervision Department of the National Medical Products Administration introduced the requirements and supervision and inspection of China's medical device production quality management specifications. Representatives from the US FDA's China office and the EU Chamber of Commerce in China introduced the requirements and relevant situations of the US and EU medical device production quality management systems.

Participating enterprises stated that they should actively adapt to the development of the medical device industry in the new era and the growing health needs of the public, further strengthen the construction of medical device production quality management systems, implement the main responsibilities of enterprises, and continuously promote the modernization of enterprise management systems and capabilities.

The meeting stressed the importance of recognizing the importance of medical device production quality management specifications; implementing medical device production quality management specifications is the statutory responsibility of medical device manufacturers. It is crucial to recognize the correlation between strengthening the construction of quality management systems and improving the quality of enterprise products. The construction of quality management systems is the fundamental and basic construction of quality management capabilities. A good quality management system is a basic prerequisite for ensuring the safety of medical devices. The meeting also emphasized the need to strengthen the awareness of enterprise subject responsibility, with the completeness of the enterprise quality management system depending on management. The meeting further stressed ensuring the continuous compliance of the quality management system.

The meeting pointed out that to continuously promote the effective implementation of medical device production quality management specifications, it is necessary to cultivate a group of typical demonstration enterprises that implement production quality management specifications to help law-abiding and standardized enterprises grow stronger. Supervision should be used to promote industry improvement and urge enterprises to implement the requirements of laws and regulations on quality management and other aspects. Social co-governance should be vigorously promoted, giving full play to the strength of all sectors of society, including the public, the government, the industry, and the media. An international exchange platform should be created to encourage enterprises to participate extensively in international exchanges and cooperation in areas such as standardized systems and risk management.