上海市药监局印发《上海市第二类医疗器械优先审批程序》

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]