Core Points - Shandong Province has introduced two new policies to streamline the approval process for innovative medical devices, effective from January 1, 2026, aimed at overcoming market entry barriers and promoting high-quality industry development [1][2] - The new policies establish clear criteria for innovative medical devices, requiring products to be domestically original in mechanism, significantly improve performance and safety compared to similar products, and have completed standardized preliminary research [1] - Approved innovative products will enter a "fast track" with technical review and administrative approval timelines reduced to 20 and 5 working days, respectively, significantly faster than conventional processes [1][2] Summary by Sections Innovative Medical Device Approval - The new regulations specify that applicants must hold patent rights or usage rights to core technologies [1] - A public announcement period of no less than 10 working days will be implemented to ensure transparency in the approval process [1] Priority Approval for Clinically Urgent Devices - The priority approval process includes devices for rare diseases, cancer treatment, and specialized medical devices for the elderly and children [2] - Eligible products will benefit from a "three-priority" service, with inspection, technical review, and administrative approval timelines set at 50, 30, and 5 working days, respectively [2] Regulatory Mechanisms - A comprehensive regulatory mechanism will be established to maintain safety standards throughout the approval process [2] - The policies adhere to principles of early intervention, tailored strategies, collaborative review, and full guidance, with a clear exit mechanism for non-compliant applicants [2] - If an innovative medical device is not registered within five years of approval, it will automatically lose its innovative status, aligning with the regulatory goal of "combining regulation and management" [2]