The 6th China Medical Device Vigilance Conference Kicks Off

  • 2022-11-25
The 6th China Medical Device Vigilance Conference (“Conference”) jointly held by the Center for Drug Reevaluation, NMPA (National Center for ADR Monitoring, China) and the China Association for Medical Devices Industry kicked off online on November 24. Themed “Innovation, Cooperation, Sharing and Promoting High-quality Development of Medical Device Vigilance”, the Conference centers on medical device regulations and new regulatory initiatives, risk management of innovative products, application of real-world data in medical device vigilance, etc. for in-depth discussion. Xu Jinghe, Member of the CPC Leading Group and Deputy Commissioner of the National Medical Products Administration (“NMPA”), attended the Conference and delivered a speech.

The Conference pointed out that in recent years, China has continued to strengthen the regulation of the lifecycle quality of medical devices and actively advanced the building of the medical device adverse event monitoring system and capability; as a result, China has steadily improved its medical device risk monitoring and vigilance capabilities, continuously accelerated scientific development, rule of law, internationalization and modernization and made significant achievements in medical device adverse event monitoring and medical device vigilance work, providing an important technical guarantee for the overall stability and continuous progress of the medical device safety situation. In the face of the new situation and new tasks of medical device vigilance at present, the Conference pointed out that it’s important to adhere to the people-centered position, enhance political positions, deepen reform and innovation, promote scientific development, accelerate the establishment of a sound medical device vigilance system in China and continuously improve the medical device risk vigilance capability.

Xu Jinghe emphasized the necessity to earnestly implement the spirit of the 20th CPC National Congress and General Secretary Xi Jinping’s remarks and instructions on drug safety, fully implement related requirements in the Implementing Opinions on Comprehensively Strengthening the Building of Drug Regulation Capability and the 14th Five-Year Plan for National Drug Safety and High-Quality Development, further improve the medical device vigilance system, deepen scientific research on medical device regulation and develop new tools, new standards and new methods for medical device regulation, to comprehensively improve medical device vigilance capability and level. He said that we should firmly grasp crucial links such as the monitoring, identification, assessment and control of medical device risks, ensure the implementation of the primary responsibilities of medical device registrants and filing parties and continuously optimize the risk closed-loop management model of beforehand prevention, in-process control and after-the-event feedback; we should adapt to the needs of regulatory work, adhere to the problem-oriented approach, advance technological innovation, focus on pandemic prevention and control devices, winning products in centralized procurement, innovative products and high-risk and implantable medical device products and strengthen special monitoring and special inspection work to further improve the effectiveness of medical device vigilance; we should study and draw on the experience of international medical device vigilance systems, accelerate building a medical device vigilance system with Chinese characteristics, actively participate in co-building the global safety regulation network of medical devices and strive to contribute Chinese wisdom and strength.

More than 20 experts and scholars from home and abroad have been invited to make presentations on the theme of medical device vigilance and regulatory science at the Conference. Among them, Yu Mengsun, Academician of the Chinese Academy of Engineering and expert in aviation medicine and biomedical engineering, gave a keynote report on “Systems Thinking - Guiding Ideology and Working Methods for Developing Medical Device Vigilance”; Wang Songling, Academician of the Chinese Academy of Sciences and expert in dentistry, introduced the Transformation and Prospects of Dentistry Innovations in China; related heads of the Department of Medical Device Regulation and the Department of Medical Device Registration of the NMPA gave presentations on strengthening medical device regulatory work and review and approval system reform to promote the high-quality development of medical devices, respectively.

The Conference will last for 2.5 days. Three sessions on medical device regulations and new regulatory initiatives, risk management of innovative medical device products and application of real-world data in medical device vigilance will be held on November 25 and 26, by which time, famous scholars and industry experts in the fields of medical device R&D, production and use in China as well as experts from domestic and foreign regulators will exchange ideas on their latest research results and look into future development trends, to contribute to the high-quality development of medical device vigilance.

Source: National Medical Productions Administration