Research on development strategy of China’s high-end medical device industry

作者：Zhihong LIU, Hui ZHU, Wei WU, Jiani LI, Yingke Xu, Jianxin Zhang · 发表于：Zhongguo Kexueyuan yuankan · 年份：2026 · DOI：10.3724/j.issn.1000-3045.20251115004 · 研究领域：Advanced Technologies in Various Fields、Biomedical Ethics and Regulation、Innovation Policy and R&D

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 innovatio...