上海发布高端医疗器械产业重磅方案，“7+X”重点产品有哪些

Core Viewpoint - Shanghai is promoting the orderly opening and application of clinical data to enhance the development of the high-end medical device industry, which is considered one of the three leading industries in the city [1][7]. Group 1: Action Plan Overview - On September 15, Shanghai released a three-year action plan aimed at promoting the full-chain development of the high-end medical device industry, with goals set for 2027 [2]. - The action plan targets the approval of over 500 new domestic Class III medical device registrations and over 100 medical device products approved in overseas markets [2]. - The plan aims to cultivate two leading enterprises with an annual output value exceeding 10 billion and establish three high-end medical device industry clusters [2]. Group 2: Industry Development and Focus Areas - The medical device industry in Shanghai has rapidly developed, with a manufacturing output value of 55.51 billion, accounting for 27.6% of the biopharmaceutical output [3]. - The action plan outlines seven areas of focus, deploying 20 key tasks related to innovation, clinical empowerment, review and approval, hospital application, enterprise cultivation, industrial ecology, and international development [3]. Group 3: Key Product Development - The action plan emphasizes the development of "7+X" key products, including high-end medical imaging products, high-end implantable 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 future innovative devices [6]. - Shanghai aims to enhance its innovation capabilities by tackling cutting-edge technologies such as brain-computer interfaces and integrated diagnosis and treatment [6]. Group 4: Regulatory and Financial Support - The action plan proposes to strengthen pre-guidance services for the registration review of Class II and III innovative medical devices, aiming to reduce the average review time for Class II devices to within 40 working days [8][9]. - Financial support will be provided through collaboration between leading industry funds and biopharmaceutical merger funds, focusing on disruptive and cutting-edge technology innovations [10]. - Shanghai Guotou will prioritize investments in key areas such as brain-computer interfaces and high-end medical equipment, providing capital support for core technology development and process optimization [10].