UIH(SH:688271) Xin Lang Cai Jing·2025-09-15 13:05Core Insights - The Shanghai Municipal Science and Technology Commission has officially released the "Action Plan for Promoting the Full-Chain Development of High-End Medical Device Industry" aimed at overcoming industry bottlenecks and enhancing global competitiveness in the high-end medical device sector [1][2] Group 1: Action Plan Overview - The action plan focuses on a systematic layout from source innovation to clinical transformation, addressing key materials, core components, and cutting-edge technologies [2] - It emphasizes the integration of clinical needs with research and development, aiming to create a full-chain innovation system [3] - The plan includes 20 key tasks across seven major areas: innovation sourcing, clinical empowerment, regulatory approval, hospital application, enterprise cultivation, industrial ecology, and international development [1][2] Group 2: Development Goals - By 2027, the plan aims to approve over 500 new domestic Class III medical device registrations and cultivate two leading enterprises with over 10 billion yuan in output [2] - The establishment of three high-end industrial clusters in Pudong, Minhang, and Jiading is also a key objective [2] Group 3: Clinical and Regulatory Enhancements - The plan seeks to streamline the clinical research process, reducing ethical review times to an average of 5 working days for single-center reviews and 10 days for multi-center reviews [3] - New regulatory procedures for innovative medical devices will prioritize clinical value and enhance the efficiency of the approval process [4] Group 4: Market Access and Payment Reforms - The action plan addresses market access by allowing direct applications from enterprises and enabling hospitals to negotiate procurement prices [5] - It explores innovative payment models involving multiple stakeholders to ensure patients can access high-quality medical devices [5] Group 5: Capital and Industry Synergy - The plan highlights the role of capital in industry development, with state-owned funds focusing on targeted investments in key areas outlined in the action plan [6] - Companies are encouraged to accelerate core technology research and international market expansion to enhance Shanghai's global competitiveness in the medical device sector [6]