According to the spirit of the document, Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Regulation of Drugs and Medical Devices to Promote the High-quality Development of the Pharmaceutical Industry [GBF [2024] No. 53], the Conference reported on the critical applications of innovative medical devices in surgical procedures, emphasized the core requirement of standardizing medical device design and development with clinical value as orientation, and centrally showcased innovative development achievements in medical robotics, pacemakers, imaging technology, high-risk surgical implants, high-end imaging equipment, brain pacemakers, and vascular intervention and implantation devices.
The Conference was presided over by Yang Xiaofang, Deputy Secretary General of CAMDI.
Yang Xiaofang, Deputy Secretary General of CAMDI
CAMDI Senior Advisor Jiang Deyuan extended a warm welcome to the attendees. He stated that the medical device industry is an important component of new quality productive forces and has received widespread social attention and high importance from the Party and government. In recent years, the central government has successively introduced a series of important documents to promote the high-quality development of the medical device industry, and the National Medical Products Administration (NMPA) has continuously advanced review, approval, and regulatory reforms, which have achieved significant results.
As one of the few social organizations with the most extensive and closest connections to enterprises in the medical device field, CAMDI has adhered to its role as a bridge and link for over 30 years since its founding, closely serving the industry. Looking ahead, CAMDI will continue to rely fully on the strong support of related authorities and the industry, center on improving professional quality and integrity across the industry, focus on common issues, and positively contribute to the long-term development of China's medical device industry.
Jiang Deyuan, Senior Advisor of the China Association for Medical Devices Industry
Gan Jingzhong, Secretary of the CPC Changping District Committee and Secretary of the Party Working Committee of Future Science City, stated in his speech that the medical device industry is a strategic emerging industry related to the national economy, people's livelihood, and national security. Changping District, an important carrier for Beijing's building of an international hub for sci-tech innovation, has superior basic conditions and a favorable industrial ecosystem and business environment. In recent years, the medical device industry in Changping District has formed a good trend of cluster development with the guidance and assistance of the NMPA and the Beijing Municipal Medical Products Administration. Gan noted that Changping District would make every effort to provide service and support, take the Conference as an opportunity to accurately grasp industry frontier trends, strengthen the guarantee of factors such as scientific research, talent, policies, finance, and space, and create a sound industrial development environment and first-class business environment.
Gan Jingzhong, Secretary of the CPC Beijing Changping District Committee and Secretary of the Party Working Committee of Future Science City
Wang Houting, member of the CPC Leading Group and Deputy Director of the Beijing Municipal Medical Products Administration, presented the Beijing Service Station for Medical Device Innovation of the Center for Medical Device Evaluation, NMPA (CMDE). He stated that in December 2023, the CMDE, the Beijing Municipal Medical Products Administration, the Beijing Municipal Science & Technology Commission, and the Administrative Commission of Zhongguancun Science Park jointly signed the Cooperation Agreement on Encouraging Medical Device Innovation and Advancing Review Capability Improvement and established the first national-level service station for medical device innovation jointly built by medical products regulatory and science and technology authorities in Beijing. The innovation service station has been committed to promoting the transformation of medical device innovation achievements and industrial development and, by building a coordinated and efficient service chain, advancing the review focus forward, supporting the transformation of innovation achievements, accelerating the application of new technologies and products, focusing on key areas, speeding up review and approval, improving inspection efficiency, and empowering industrial development.
Wang Houting, Member of the CPC Leading Group and Deputy Director of the Beijing Municipal Medical Products Administration
Subsequently, Sun Liguang, Secretary of the CPC Leading Group of the Beijing Municipal Medical Products Administration, Wang Houting, member of the CPC Leading Group and Deputy Director of the Beijing Municipal Medical Products Administration, Gan Jingzhong, Secretary of the CPC Beijing Changping District Committee and Secretary of the Party Working Committee of Future Science City, and Liu Qiang, Deputy Director of the Future Science City Administrative Committee and Deputy Mayor of Beijing Changping District, jointly held an unveiling ceremony for the innovation service station in Changping.
Witnessed by the attendees, Liu Qiang, Deputy Director of the Future Science City Administrative Committee and Deputy Mayor of Beijing Changping District, officially launched the "China High-end Medical Equipment Innovation and High-Quality Development Exchange Center." The exchange center located in Champion Bio will form a "dual-core driving" pattern with the innovation service station under the guidance of the NMPA and the Beijing Municipal Medical Products Administration. The establishment of the exchange center is an important measure in response to the national innovation-driven development strategy, aiming to promote industrial collaboration, facilitate full-chain technical exchange and all-factor cooperation, stimulate innovation and transformation of high-end medical equipment, accelerate the development of new quality productive forces for medical equipment, and boost the industry's high-quality innovative development.
Liu Qiang, Member of the Standing Committee of the CPC Beijing Changping District Committee, Deputy Mayor of Changping District, Deputy Director of the Future Science City Administrative Committee, and Director of the Zhongguancun Science Park Changping Park Administrative Committee
Lu Qian, Vice President of Beijing Tsinghua Changgung Hospital, gave an in-depth analysis of the latest technological trends and developments in the global medical device field in her speech titled "Presentation of Frontier Technology Development in the Global Medical Device Field."
Lu Qian, Vice President of Beijing Tsinghua Changgung Hospital
In her speech titled "Standardizing Medical Device Design and Development with Clinical Value as Orientation," Guo Zhaojun, Head of the First Review Department of the CMDE, provided key insights for the attendees from a review perspective. She explained in detail the key points and common issues in the technical review of innovative medical devices, which provided important references for participating enterprises, helping them better navigate the R&D process and improve the pass rate of reviews.
Guo Zhaojun, Head of the First Review Department of the CMDE
Subsequently, in the enterprise representative reporting session, representatives from eight enterprises showcased their technological achievements and development plans in frontier areas such as high-end medical device innovation, intelligent equipment R&D, frontier imaging technology, neuromodulation, and intervention and implantation devices, manifesting the innovation vitality and strong development momentum of the medical device industry in Changping District across multiple key fields. Wu Di, General Manager of Sinovation (Beijing) Medical Technology Co., Ltd., shared the innovative development path of neurosurgical robots and emphasized their precision and intelligence characteristics and application prospects in brain disease treatment. Dong Linmeng, Deputy Regulatory Affairs Director at Medtronic (Shanghai) Management Co., Ltd., presented the innovative advantages of leadless pacemakers, highlighting their minimally invasive nature, safety, and role in improving patients' quality of life. Xiang Jun, CEO of the X-ray Business Unit of Shanghai United Imaging Healthcare Co., Ltd., discussed the innovative exploration of Chinese-developed high-end intelligent DSA and focused on breakthroughs in imaging technology and the clinical diagnostic value thereof. Guo Ye, Vice President of Johnson & Johnson Medical (Shanghai) Ltd., explained the interventional left ventricular assist system and emphasized its minimally invasive nature and support for heart failure patients. Tian Yuan, Chairman of Mevion Medical Equipment Co., Ltd., introduced the achievements of the integrated proton therapy system and highlighted the development and application of precision radiotherapy technology. Wang Yang, Head of CT at Siemens Healthineers Greater China, discussed dual-source photon CT and 7T technology and emphasized their advanced nature and diagnostic significance in the field of medical imaging. Hao Hongwei, General Manager of Beijing Pins Medical Co., Ltd., presented innovations in brain pacemakers and implantable neuromodulation and highlighted their application effects in neurological disease treatment. Wang Guohui, Chairman of Shanghai HeartCare Medical Technology Co., Ltd., shared innovations in high-end cerebrovascular intervention devices and focused on device performance improvement and clinical need satisfaction.
Wu Di, General Manager and Co-founder of Sinovation (Beijing) Medical Technology Co., Ltd.
Dong Linmeng, Deputy Regulatory Affairs Director at Medtronic (Shanghai) Management Co., Ltd.
Xiang Jun, CEO of the X-ray Business Unit of Shanghai United Imaging Healthcare Co., Ltd.
Guo Ye, Vice President of Johnson & Johnson Medical (Shanghai) Ltd.
Tian Yuan, Chairman of Mevion Medical Equipment Co., Ltd.
Wang Yang, Head of CT at Siemens Healthineers Greater China (Siemens Shanghai Medical Equipment Ltd.)
Hao Hongwei, General Manager of Beijing Pins Medical Co., Ltd.
Wang Guohui, Chairman of Shanghai HeartCare Medical Technology Co., Ltd.
Lei Ping, Member of the CPC Leading Group and Deputy Commissioner of the NMPA
In his concluding remarks, Lei Ping, member of the CPC Leading Group and Deputy Commissioner of the NMPA, highly praised the successful hosting of the Conference. He stated that since the approval of the first Class III innovative medical device in December 2014, 334 Class III innovative products have been approved, with a particularly high number in the past two years, and expressed confidence that more innovative products will be marketed in 2025. The NMPA will continue to strengthen institutional supply, improve central-local linkage service mechanisms, enhance pre-approval services, keep improving the medical device standard system, and make every effort to elevate capacity building. He emphasized that innovation should be oriented toward clinical value, instead of conducting R&D merely for the sake of R&D. Clinical needs are the source of innovation, and enterprises are the driving force for innovative R&D. Only with the proper matching of the two can China's medical device innovation and R&D enter the fast lane, truly meet people's health needs, and realize the clinical value of medical devices.