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]

Core Viewpoint - The Shanghai Municipal Drug Administration has issued a priority approval procedure for Class II medical devices, aimed at expediting the approval process for certain categories of medical devices that meet specific criteria [1] Group 1: Priority Approval Criteria - Medical devices that have completed preliminary research and are in a stable design phase can be included in the priority approval process if they meet one of the following conditions: 1. Devices included in national or municipal key scientific and technological projects or major research and development plans [1] 2. Devices for diagnosing or treating rare diseases that demonstrate significant clinical advantages [1] 3. Devices for diagnosing or treating diseases prevalent among the elderly, where no effective diagnostic or treatment methods currently exist [1] 4. Devices specifically designed for children that show significant clinical advantages [1] 5. Devices that are urgently needed in clinical settings [1] 6. Other medical devices that should be included in the priority approval process [1]

剧上海市人民政府网，上海市药品监督管理局发布《第二类医疗器械优先审批程序》，旨在优化医疗器 械审评审批流程，保障临床使用需求。该程序针对列入国家或市科技重大项目的器械，以及诊治罕见 病、老年病和儿童病的器械，提供优先审批通道。符合条件的申请需提交相关证明材料，经审核后可进 入优先审批程序。新规自2025年9月1日起实施，有效期至2030年8月31日，旨在加快优质医疗器械的上 市速度。 ...