•  
  •  
 

Bulletin of Chinese Academy of Sciences (Chinese Version)

Keywords

high-end medical devices, critical bottleneck technologies, industrial innovation ecosystem, strategic research

Abstract

High-end medical device industry serves as a critical technological foundation for modern healthcare systems and represents an important indicator of a country’s innovation capacity, advanced manufacturing capability, and industrial governance effectiveness. Amid intensifying global technological competition, upgrading healthcare demands, reshaping regulatory regimes and restructuring global supply chains, promoting the high-quality development of the high-end medical device industry has become essential for enhancing indigenous innovation capacity and ensuring industrial security. This study examines international experiences from the United States, Germany, Japan, and other countries in innovation ecosystem development, regulatory review optimization, market payment incentives, participation in international rules, and governance of AI-enabled medical devices. Based on expert interviews and industry investigations, the study identifies major constraints affecting China’s high-end medical device development, including inadequate policy coordination, insufficient original innovation capacity and interdisciplinary talent supply, underdeveloped market access and value evaluation mechanisms, and an increasingly complex international competitive environment. The study argues that China should adopt differentiated development strategies based on the maturity, industrial foundation, and competitive landscape of different technological fields, with a focus on strengthening innovation governance, advancing breakthroughs in critical core technologies, improving value realization mechanisms for innovative products, and enhancing the resilience of industrial and supply chains. Accordingly, policy recommendations are proposed from the perspectives of innovation governance optimization, industrial ecosystem development, market mechanism improvement, and international competitiveness enhancement, aiming to facilitate the transition of China’s high-end medical device industry from scale-driven growth toward innovation-led development and strengthen its global competitiveness.

First page

1355

Last Page

1364

Language

Chinese

Publisher

Bulletin of Chinese Academy of Sciences

References

[1] 国家发展和改革委员会. 产业结构调整指导目录（2024年本）. 北京: 中国标准出版社, 2023.National Development and Reform Commission. Guidance Catalog for Industrial Structure Adjustment (2024 Ed). Beijing: Standards Press of China, 2023. (in Chinese)

[2] 国家药品监督管理局. 2020年度医疗器械注册工作报告. 北京: 国家药品监督管理局, 2021. National Medical Products Administration. 2020 Annual Report on Medical Device Registration. Beijing: National Medical Products Administration, 2021. (in Chinese)

[3] 国家药品监督管理局. 2021年度医疗器械注册工作报告. 北京: 国家药品监督管理局, 2022. National Medical Products Administration. 2021 Annual Report on Medical Device Registration. Beijing: National Medical Products Administration, 2022. (in Chinese)

[4] 国家药品监督管理局. 2022年度医疗器械注册工作报告. 北京: 国家药品监督管理局, 2023. National Medical Products Administration. 2022 Annual Report on Medical Device Registration. Beijing: National Medical Products Administration, 2023. (in Chinese)>/br>

[5] 国家药品监督管理局. 2023年度医疗器械注册工作报告. 北京: 国家药品监督管理局, 2024. National Medical Products Administration. 2023 Annual Report on Medical Device Registration. Beijing: National Medical Products Administration, 2024. (in Chinese)

[6] 国家药品监督管理局. 2024年度医疗器械注册工作报告. 北京: 国家药品监督管理局, 2025. National Medical Products Administration. 2024 Annual Report on Medical Device Registration. Beijing: National Medical Products Administration, 2025. (in Chinese)

[7] CommissionEuropean. Commission Implementing Regulation (EU) 2025/1197 of 20 May 2025 imposing certain measures pursuant to Regulation (EU) 2022/1031 of the European Parliament and of the Council on the International Procurement Instrument. Official Journal of the European Union, 2025, L 150: 1.

[8] 董洁, 张素娟, 孟潇. 我国医疗器械产业创新生态系统演化研究. 中国卫生事业管理, 2020, 37(11): 876-880. Dong J, Zhang S J, Meng X. Research on the evolution of innovation ecosystem in China’s medical device industry. Chinese Health Service Management, 2020, 37(11): 876-880. (in Chinese)

[9] Federal Ministry for Economic Affairs and Climate Action. Medical technology and medical device industry in Germany under the banner of the Medical Device Regulation. Bonn: Federal Ministry for Economic Affairs and Climate Action, 2025: 8.

[10] 陈光. 日本科技规划的实施机制分析与经验借鉴——基于对第1期至第6期《科技基本计划》历史演进的梳理. 科学学与科学技术管理, 2022, 43(2): 32-48. Chen G. Analysis of the implementation mechanism of Japan’s science and technology plans and its implications: Based on the historical evolution from the 1st to 6th Science and Technology Basic Plan. Science of Science and Management of S.& T., 2022, 43(2): 32-48. (in Chinese)

[11] 鄢广. 英国药品和医疗器械监管局法律监管情况概述及启示. 中国药房, 2020, 31(3): 265-270. Yan G. Overview and enlightenment of legal regulation of the UK Medicines and Healthcare Products Regulatory Agency. China Pharmacy, 2020, 31(3): 265-270. (in Chinese)

[12] 李佳明, 丁锦希, 黄晟馨, 等. DRG付费下法国创新医药产品医保支付政策研究. 中国药房, 2023, 34(12): 1409-1414. Li J M, Ding J X, Huang S X, et al. Study on medical insurance payment policy for innovative pharmaceutical products in France under DRG payment. China Pharmacy, 2023, 34(12): 1409-1414. (in Chinese)

[13] Aboy M, Crespo C, Stern A. Beyond the 510(k): The regulation of novel moderate-risk medical devices, intellectual property considerations, and innovation incentives in the FDA’s De Novo pathway. NPJ Digital Medicine, 2024, 7(1): 29.

[14] 吴晶, 董心月, 赵博雅. 美国DRG下高值创新医疗技术的支付政策及启示. 中国医疗保险, 2022, (6): 118-124. Wu J, Dong X Y, Zhao B Y. Payment policies and implications for high-value innovative medical technologies under US-DRG. China Health Insurance, 2022, (6): 118-124. (in Chinese)

[15] Farmer S A, Fleisher L A, Blum J D. The transitional coverage for emerging technologies pathway—Enhancing innovation while establishing patient safeguards. JAMA Health Forum, 2023, 4(8): e232780.

[16] 张秋玉, 王芸, 胡元霞, 等. 我国药品及医用耗材集中带量采购政策的实施现状及建议. 中国药房, 2022, 33(2): 136-141. Zhang Q Y, Wang Y, Hu Y X, et al. Implementation status and suggestions of volume-based procurement policy for drugs and medical consumables in China. China Pharmacy, 2022, 33(2): 136-141. (in Chinese)

[17] 阎德学. 日本全球卫生战略评析. 国际问题研究, 2022, (5): 78-98. Yan D X. An analysis of Japan’s global health strategy. International Studies, 2022, (5): 78-98. (in Chinese)

[18] U.S. Food and Drug Administration. Marketing submission recommendations for a predetermined change control plan for artificial intelligence-enabled device software functions: Guidance for industry and Food and Drug Administration staff. 2024.

[19] Japan Federation of Medical Devices Associations (JFMDA). Study on review of AI-enabled medical devices: Report of research results. 2025.

[20] 林勇涛. 医疗人工智能、医疗决策与医疗说明义务——德国经验与中国借鉴. 德国研究, 2025, 40(4): 134-159. Lin Y T. Medical artificial intelligence, medical decision-making and medical explanation obligation—German experience and implications for China. German Studies, 2025, 40(4): 134-159. (in Chinese)

[21] 孟芸, 许慧雯, 易力, 等. 医疗器械标准化工作促进行业创新发展的思考. 中国医药导刊, 2025, 27(5): 432-436. Meng Y, Xu H W, Yi L, et al. Thoughts on promoting innovation and development in the medical device industry through standardization. China Journal of Pharmaceutical Guide, 2025, 27(5): 432-436. (in Chinese)

[22] 迈瑞医疗. 2025年半年度报告. 深圳: 迈瑞医疗, 2025. Medical Mindray. 2025 Semi-annual Report. Shenzhen: Mindray Medical, 2025. (in Chinese)

[23] 张立强, 李欣芳, 李响, 等. DRG, DIP付费改革下结余留用政策逻辑与思考. 中国卫生经济, 2023, 42(5): 13-16. Zhang L Q, Li X F, Li X, et al. The logic and reflection on the surplus retention policy under the DRG and DIP payment reforms. Chinese Health Economics, 2023, 42(5): 13-16. (in Chinese)

[24] 黄立奇. 美国FDA医疗器械注册申请电子提交对我国的启示. 生物医学工程学进展, 2025, 46(4): 457-462. Huang L Q. Enlightenment of electronic submission for US FDA medical device registration to China. Progress in Biomedical Engineering, 2025, 46(4): 457-462. (in Chinese)

Download
Request a Copy

Share

COinS