上海发布行动方案促进高端医疗器械产业发展

Core Viewpoint - The "Action Plan for Promoting the Full-Chain Development of High-End Medical Device Industry in Shanghai" aims to enhance the high-quality development of the high-end medical device industry in Shanghai, establishing it as a globally influential hub in this sector [1] Group 1: Industry Development Goals - The medical device industry in Shanghai has rapidly developed, with a manufacturing output value of 55.51 billion yuan, accounting for nearly 30% of the total output value of the biopharmaceutical sector [1] - By 2027, the plan targets the approval of over 500 new domestic Class III medical device registrations and over 100 medical device products approved in overseas markets [1] - The plan aims to cultivate two leading enterprises with an annual output value exceeding 10 billion yuan and establish three high-end medical device industry clusters [1] Group 2: Key Tasks and Innovations - The plan outlines 20 key tasks focusing on innovation sources, clinical empowerment, review and approval processes, application in hospitals, enterprise cultivation, industrial ecology, and international development [1][2] - It emphasizes enhancing innovation capabilities through strengthening basic research, advancing key materials and core production processes, and promoting the application of artificial intelligence technologies [1] Group 3: Clinical Research and Approval Optimization - The plan encourages medical institutions to undertake clinical trials for high-end medical devices, aiming to compress the overall ethics review process to within three weeks [2] - It seeks to shorten the internal time for initiating clinical trials to within 25 weeks [2] - The plan supports collaboration between regulatory bodies and research institutions to develop regulatory science research and revise product registration guidelines [2] Group 4: Enterprise Cultivation and Ecosystem Building - The plan supports the cultivation of leading enterprises through mergers and acquisitions and encourages foreign companies to establish regional headquarters and R&D centers in Shanghai [3] - It promotes a "product + service" model and the development of comprehensive solutions that include equipment, consumables, services, and training [3] - The plan aims to create three high-end medical device industry clusters in specific districts, enhancing the innovation ecosystem and financial support for the industry [3] Group 5: International Development - The plan proposes measures to facilitate import and export processes, including the implementation of Chinese labeling for imported medical devices [4] - It aims to expand the categories and scope of bonded maintenance services for high-tech, high-value-added products [4] - The plan emphasizes deepening international cooperation and providing comprehensive services for enterprises looking to expand globally [4]