发布行动方案 上海力促高端医疗器械产业全链条发展

Core Insights - The Shanghai Municipal Government has released an action plan to promote the development of the high-end medical device industry, aiming to achieve significant milestones by 2027, including over 500 new domestic Class III medical device registrations and over 100 new products approved in overseas markets [1] Focus on Key Product Categories - The action plan identifies eight key product categories for development: high-end medical imaging products, high-end implantable and interventional products, high-end surgical systems, high-end in vitro diagnostic products, high-end radiation therapy products, high-end rehabilitation products, high-end artificial intelligence medical devices, and innovative future devices [2] - Specific advancements in high-end medical imaging include accelerating the upgrade of positron emission tomography and X-ray computed tomography devices, as well as developing micro home ultrasound devices [2] - In high-end surgical systems, the plan emphasizes the upgrade of laparoscopic surgical robots and the development of flexible surgical robots [2] - For high-end radiation therapy products, the focus is on upgrading proton therapy systems and developing flash radiation therapy devices [2] - The plan also highlights the need for advancements in AI medical devices, including intelligent medical imaging diagnostic software and surgical navigation systems [2] Deployment of Key Tasks - The action plan outlines 20 key tasks across seven areas: innovation sourcing, clinical empowerment, review and approval, hospital application, enterprise cultivation, industrial ecology, and international development [3] - Financial support initiatives include encouraging collaboration between leading industry funds and industrial clusters, supporting market-oriented medical device venture capital funds, and developing innovative medical device insurance mechanisms [3] Promoting International Development - The action plan aims to facilitate import and export processes, including optimizing customs measures for medical device R&D, production, and sales [4] - It also emphasizes international collaboration, providing comprehensive services for enterprises going global, and promoting medical device innovations through various platforms [4] - The plan seeks to reduce the time required for various processes, such as clinical research and ethical review, aiming to compress the overall ethical review process to within three weeks [4] Optimizing Review and Approval Services - The action plan supports pilot reforms that allow companies with medical device registrations to produce Class II and III devices in Shanghai [5] - It encourages pilot medical institutions to continue developing and filing self-researched reagents based on clinical needs [5] Industry Outlook - Analysts are optimistic about the medical device sector, anticipating a new development phase driven by improved internal policies and external market expansion [6][7] - The industry is expected to experience a recovery in performance and valuation, with core drivers being domestic policy optimization and accelerated globalization [7] - Future growth is projected to rely on technological platform development, AI diagnostics, and the expansion of consumer healthcare, indicating a shift towards higher-level industry development [7]