近日，上海市人民政府办公厅发布《上海市促进高端医疗器械产业全链条发展行动方案》。其中提到， 到2027年，上海将新增首次获批境内第三类医疗器械注册证超500件，新增在海外市场获批医疗器械产 品超100件，培育年产值超100亿元、具备较强国际竞争力的龙头企业2家，建设高端医疗器械产业集聚 区3个。 聚焦八类重点发展产品 具体来看，在重点发展产品方面，《行动方案》明确，上海将主要聚焦高端医学影像产品、高端植入介 入产品、高端手术系统、高端体外诊断产品、高端放射治疗产品、高端康复治疗产品、高端人工智能医 疗器械、未来新型创新器械八类重点发展产品。 高端医学影像产品方面，《行动方案》提出，加快正电子发射及X射线计算机体层成像扫描设备、高清 血管造影设备等高性能产品迭代升级，推动微型家用超声设备等产品研发。 高端手术系统方面，《行动方案》提出，加快腔镜手术机器人等高性能手术系统迭代升级，推动柔性手 术机器人等新一代手术系统研发。 高端放射治疗产品方面，《行动方案》提到，加快质子治疗系统、硼中子俘获治疗设备等产品迭代升 级，推动闪光放疗设备等产品研发。 此外，针对高端人工智能医疗器械，《行动方案》表示，加快智能医学影像诊 ...

Core Viewpoint - The Shanghai Municipal Government has released an action plan to promote the development of the high-end medical device industry, aiming for significant growth in product approvals and the establishment of competitive enterprises by 2027 [1] Focus on Key Development Products - The action plan identifies eight key product categories for development, including high-end medical imaging, implantable devices, surgical systems, in vitro diagnostics, radiation therapy, rehabilitation devices, AI medical devices, and innovative future devices [2] - Specific advancements are targeted in high-end medical imaging, surgical systems, and radiation therapy products, with a focus on upgrading existing technologies and developing new systems [2] Deployment of Key Tasks - The action plan outlines 20 key tasks across seven areas: innovation, clinical empowerment, review and approval, hospital application, enterprise cultivation, industrial ecology, and international development [3] - Financial support initiatives include collaboration with venture capital and insurance products tailored for the medical device sector [3] Promotion of International Development - Measures to facilitate international trade include optimizing customs processes and enhancing international cooperation through various platforms and events [4] - The plan emphasizes reducing the time required for clinical trials and regulatory approvals, aiming to streamline processes significantly [4] Optimizing Review and Approval Services - The action plan supports pilot reforms for companies with medical device registrations to produce devices in Shanghai and encourages self-research reagent development [5] Industry Outlook - Analysts predict a new development phase for China's medical device industry, driven by improved internal policies and external market expansion [6] - The industry is expected to experience a recovery in performance and valuation, with a focus on innovation and globalization [6]

Core Viewpoint - The Shanghai Municipal Government has issued the "Action Plan for Promoting the Full-Chain Development of High-End Medical Device Industry," marking a significant shift in focus towards high-end medical devices as an independent sector rather than a subset of biomedicine [1][4]. Summary by Sections 1. Background and Rationale - The issuance of the action plan is a response to the rapid development of the local medical device industry, which has reached a manufacturing output of 55.51 billion yuan, accounting for 27.6% of the biomedicine sector [4][14]. - The plan aims to align with national strategies and international competition, particularly in advanced fields like AI and surgical robotics, to establish Shanghai as a global industrial hub [4][7]. 2. Quantitative Goals - The action plan sets four major quantitative targets to be achieved by 2027: - Complete 500 new Class III medical device registrations within three years, averaging about 170 per year, indicating a significant acceleration in approval processes [8]. - Achieve 100 overseas product approvals, emphasizing the importance of global market entry [9]. - Cultivate two leading enterprises with annual revenues exceeding 10 billion yuan, focusing on quality over quantity [10]. - Establish three high-end medical device industrial clusters in Pudong, Minhang, and Jiading, promoting specialized regional development [11]. 3. Key Product Areas - The action plan identifies eight key product areas for support, including: - High-end medical imaging - High-end implantable devices - High-end surgical systems - High-end in vitro diagnostics (IVD) - High-end radiation therapy [12][13]. 4. Comprehensive Support Strategy - The plan emphasizes a full-chain support approach, addressing every stage from research and clinical trials to approval and market entry [16][19]. - Specific tasks include: - Innovation sourcing - Clinical empowerment - Streamlined approval processes - Product application support - Enterprise cultivation - Building an innovative ecosystem [17]. 5. Industry Impact and Signals - The action plan signals a shift in the role of hospitals from mere application sites to key players in innovation and product evaluation [22]. - It aims to attract more investment by reducing uncertainties related to payment and financial mechanisms, thus encouraging capital inflow into the sector [22][23]. 6. Future Outlook - The plan represents a strategic move for Shanghai to enhance its global competitiveness in high-end medical devices through institutional innovation and financial support [24][25]. - The success of this initiative will be measured by the ability to cultivate internationally influential enterprises and translate institutional innovations into tangible outcomes [25].