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2025年中国创新医疗器械行业产业链、政策、市场现状及未来趋势研判:国家医疗器械创新审评审批质量效率明显提升,国内获批上市创新医疗器械数量持续增长[图]
Chan Ye Xin Xi Wang·2025-06-05 01:16

Industry Overview - Innovative medical devices refer to new medical equipment with core technology patents, internationally leading technology levels, and significant clinical application value, such as AI-assisted diagnostic devices, 3D-printed implants, and gene testing instruments [2][5] - The development process for innovative medical devices in China typically takes about 5-8 years, including R&D, clinical trials, and regulatory approval [2] - The number of approved innovative medical devices in China has been increasing, with 65 approved in 2024 and 34 in the first four months of 2025 [1][5] Market Status - The medical device industry is a crucial pillar of the modern healthcare system, with significant strategic importance and growth potential [5] - The Chinese government has implemented various policies to encourage innovation and the domestic production of high-end medical devices, leading to rapid industry development [5][7] Enterprise Landscape - The competitive landscape of the innovative medical device industry in China is still in the R&D investment phase, resulting in a low market concentration with over 200 approved production enterprises [11] - Leading companies in the innovative medical device sector include Beijing Pinchi Medical Equipment Co., Ltd., Shenzhen Xianjian Technology Co., Ltd., and Shanghai United Imaging Healthcare Co., Ltd., among others [12][11] Future Trends - The integration of artificial intelligence and the Internet of Things is accelerating in the medical device field, enhancing diagnostic efficiency and accuracy [16] - Domestic companies are rapidly advancing in high-end medical equipment and consumables, with increasing market share for products like vascular stents and artificial joints [17] - Chinese innovative medical device companies are actively expanding into overseas markets through technology licensing and cross-border cooperation [18]