The 2023 Annual Policy Conference of the China Association for Medical Devices Industry (CAMDI) was grandly held in Beijing on May 26, 2023.

Xu Jinghe, Deputy Commissioner of the National Medical Products Administration (NMPA), attended the conference and delivered an important speech, and Wang Xiaoyang, Deputy Director-General of the Department of Consumer Goods Industry of the Ministry of Industry and Information Technology, Lyu Ling, Director-General of the Department of Medical Device Registration of NMPA, Li Jun, Deputy Director-General of the Department of Medical Device Regulation of NMPA, Sun Lei, Director of the Center for Medical Device Evaluation, NMPA, and Zhang Hui, Deputy Director-General of the National Institutes for Food and Drug Control, attended the morning session and delivered keynote speeches.
The morning session was chaired by CAMDI Executive Vice President Jiang Feng and CAMDI Senior Advisor Jiang Deyuan in succession and was attended by nearly 500 member representatives.

CAMDI President Zhao Yixin delivered the opening remarks, in which she expressed delight in returning to face-to-face communication with the guests offline and gladness that the industry could continue to develop rapidly under the support and guidance of national ministries and commissions during the pandemic and wished the conference a complete success.

Executive Vice President Jiang Feng briefly reported on CAMDI’s key work during the three-year pandemic. During the pandemic, CAMDI actively cooperated with various national ministries and commissions in research on the production capacity status and industry and supply chains of anti-pandemic medical device products. According to incomplete statistics, CAMDI organized 90 member enterprises to donate a total of RMB 360 million in monetary and material forms. Regarding CAMDI’s work, he briefly introduced aspects such as cooperating with the work of government departments, organizing various online and offline activities, formulating industry standards, conducting work related to industry alliances, conducting international cooperation and publicizing CAMDI.



Then, Jiang Feng introduced CAMDI Senior Advisor Jiang Deyuan with great respect: he previously taught at Beijing Medical University and is currently an expert with the Special Government Allowance of the State Council, a professor and one of the tenth National Educational Inspectors; he successively served as the Deputy Director of the Office of the China Food and Drug Administration (CFDA, predecessor of NMPA) and NMPA, the President and Party Secretary of the CFDA Institute of Executive Development, the Director of the Bureau of Investigation and Enforcement of CFDA, and the Director-General and Inspector of the Department of Medical Device Registration of CFDA. He had long been working in the national drug regulatory departments and directly participating in the formulation of regulations and policies and is familiar with the industry situations. Jiang Feng stated that the appointment of Jiang Deyuan as Senior Advisor will greatly enhance CAMDI’s operational and regulatory service capabilities. The session was subsequently hosted by Jiang Deyuan.

Deputy Commissioner Xu Jinghe delivered a speech at the beginning of the drug regulation session. Xu Jinghe first expressed his congratulations on the holding of the Annual Policy Conference and the achievements of CAMDI and expressed gratitude to the industry friends who support the development of medical device regulation. Xu Jinghe emphasized that the health of the people is among the country’s most fundamental interests, and over the years, NMPA has been adhering to Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era as its action guide and the “Four Strictest (strictest standards, regulation, punishment and accountability)” as its fundamental guidance and sticking to the scientific, legalized, international and modern development path, and has achieved significant development, changes and progress in medical device regulation through continuous efforts. Then, he elaborated on the progress and development of medical device regulation reform and innovation from six aspects, including the building of legal and standard systems, reform of the review and approval system, lifecycle quality regulation, services for pandemic prevention and control, regulatory capability building, and international exchanges and cooperation. Xu Jinghe particularly stated that according to an in-depth analysis of the current medical device regulation and industry development, China’s medical device industry is still in a “golden period of development”, and the industry should seize this rare opportunity and accelerate the innovative and high-quality development of enterprises. At last, Xu Jinghe made “four more-actively” suggestions to CAMDI and all its members: more actively integrate into the overall development of the Party and the country, more actively promote the comprehensive implementation of the primary responsibility of enterprises and the comprehensive construction of quality management systems, more actively promote industry self-disciplined development, and more actively participate in international exchanges and cooperation. He called on industry practitioners to fully guard the bottom line of medical device safety, lead and advance the innovative and high-quality development of the industry, and make new and greater contributions to the protection and promotion of public health.

Then, Wang Xiaoyang, Deputy Director-General of the Department of Consumer Goods Industry of the Ministry of Industry and Information Technology, delivered a keynote speech titled “Analysis of the Development Situation and Tasks of China’s Pharmaceutical Industry”, in which he provided a detailed analysis of the development of the pharmaceutical industry in the first two years of the 14th Five-Year Plan period, the situation and challenges facing the industry in the mid-to-late stage of the 14th Five-Year Plan period, and all-out promotion of the high-quality development of the pharmaceutical industry.

Lyu Ling, Director-General of the Department of Medical Device Registration of NMPA, presented the “Current Situation of Medical Device Registration Administration in China and Key Work for Next Step”, in which she provided detailed descriptions of the current situation of medical device registration administration in China from aspects including the scale of the medical device industry, the registration situation of Class II, Class III and imported medical devices and some hot areas.


Li Jun, Deputy Director-General of the Department of Medical Device Regulation of NMPA, presented the practice and innovation of China’s medical device regulation to the participants using detailed data, emphasizing that the focus of medical device regulation in 2023 will be on strengthening regulation, supervision and inspection, online sales monitoring and disposal, etc.

Sun Lei, Director of the Center for Medical Device Evaluation, NMPA, delivered a report titled “Building a Modern Review System through Innovative Development”, in which he sorted out the progress of domestic substitution in medical devices over the past 20 years and the rapid development of China’s medical device industry, and stated that the focus for 2023 is to start building a V2.0 modern review system.

Zhang Hui, Deputy Director-General of the National Institutes for Food and Drug Control, delivered a report titled “Current Situation and Key Work of Medical Device Standards and Classification Management” from three aspects, including the current situation of management of medical device standards, an overview of medical device classification work, and the key work for 2023, and stated that the key tasks for 2023 include completing standard formulation and revision, strengthening the management of standard committees, conducting daily classified demarcation, revising the IVD classification catalog, dynamically adjusting catalogs, and conducting key technological research.
The afternoon session is the medical policy session. Chen Quansheng, economist and former counselor to the State Council and former Director of the Research Department of Industrial Transport and Trade, Research Office of the State Council, Yu Xinhua, Institute Director of the Center for Medical Device Standardization Administration NMPA, Chen Yan, Division Head of the Center for Food and Drug Inspection of NMPA, Senior Engineer Zhao Yan from the Center for Drug Reevaluation, NMPA, Guo Yuanyuan, Division Head of the Center for Information, NMPA, Jin Weigang, Vice President of the China Association of Social Security, and Professor Zhao Kun from the National Center for Drug and Health Technology Evaluation and Vanke School of Public Health, Tsinghua University, attended the session and delivered keynote speeches.


The session was chaired by CAMDI Secretary-General Xu Shan.


Chen Quansheng, a former counselor to the State Council, delivered a report titled “Macro-economic Situation and Innovation Driving” for the participants, in which he elaborated on the specific trends in the macro-economy from aspects of demand, consumption trends and forms of enterprises and emphasized that “employment is pivotal to people’s well-being and income is the source of people’s well-being” and actively developing private enterprises is a way of breakthrough at present.


Yu Xinhua, Institute Director of the Center for Medical Device Standardization Administration NMPA provided a detailed analysis in his report titled “Management of Enterprises’ Lead in Drafting Medical Device Standards and Practice of Classified Demarcation of Medical Devices”, in which explained the background and main content of the related Regulations and analyzed how to determine the management attributes, management categories, criteria and dynamic adjustments of medical device classification work.


Chen Yan, Division Head of the Center for Food and Drug Inspection of NMPA, explained the situation of unannounced inspections of medical devices in 2022 from aspects, including the norms of unannounced inspection work, the composition of the inspection team, the situation of unannounced inspections, the key inspection content, and made suggestions.


Senior Engineer Zhao Yan from the Center for Drug Reevaluation, NMPA delivered a report titled “Current Situation and Prospects of Medical Device Adverse Event Monitoring”, in which she summarized the current situation of monitoring and evaluation work: significant improvement in the quantity and quality of reports, enhanced regulatory capabilities, continuously strengthened communication, and thoroughly advanced research development, and provided a detailed explanation of the future pilot work plan for medical device vigilance.


Guo Yuanyuan, Division Head of the Center for Information, NMPA, detailed the framework, construction content and key tasks of smart regulation of medical devices in the report titled “Empowering the Modernization of Medical Device Regulation through Digitalization”. She then gave valuable suggestions regarding the implementation steps of the digital transformation of medical device enterprises, related existing problems, etc.


Jin Weigang, Vice President of the China Association of Social Security, stated his opinions in the report titled “Analysis of Focuses in Current Medical Insurance Reform”, of which the contents, such as how to advance the implementation of the DRG/DIP payment method, continuous adjustments and updates of the National Reimbursement Drug List (NRDL), improvement of the centralized procurement of NRDL drugs, formation of a long-term mechanism to ensure fund security, and exploration of the establishment of a long-term care insurance system, are all focuses of the industry.


 Professor Zhao Kun from the National Center for Drug and Health Technology Evaluation and Vanke School of Public Health, Tsinghua University delivered a report titled “Promoting Value Judgment of Medical Devices through Health Technology Assessment (HTA)”, in which he explained how to apply the value concept of HTA to the lifecycle management of innovative products.
This conference was strongly supported by China Strategic Alliance of Medical Device Innovation, Mid-Link Biomedical Technology Group Co., Ltd., Beijing Xinranyicheng Medicine & Technology Co., Ltd., Thermo Fisher Scientific (China) Co., Ltd., HTDK (Shanghai) Co., Ltd., Jiangsu Science Standard Medical Testing Co., Ltd., Beijing Zhongke Xinyi Pharmaceutical Technology Co., Ltd., and Innomd.org.