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].