全力支持高端医疗器械重大创新，国家药监局发布十大举措

Core Viewpoint - The National Medical Products Administration (NMPA) of China is implementing special reviews for high-end medical devices that are domestically innovative, internationally leading, and have significant clinical application value to support their development and international expansion [1][2][3] Regulatory Measures - The NMPA has announced ten key measures focusing on the entire lifecycle regulation of high-end medical devices, including optimizing review and approval processes, strengthening post-market supervision, and enhancing standard system construction [1][2] - The approval time for clinical trials of medical devices has been reduced from 60 working days to 30 working days, with a focus on advancing the review process to the product development stage [2][3] Innovation and Approval Process - Since 2014, the number of approved innovative medical devices has significantly increased from 33 to 323 by April 2023, indicating a rapid acceleration in technology breakthroughs and product launches in high-end medical devices [3] - The NMPA will continue to implement special reviews for high-end innovative medical devices, ensuring priority processing under the principles of early intervention, dedicated responsibility, and scientific review [3][4] Standardization and Guidance - The NMPA aims to enhance standardization research to help domestic high-end medical devices compete internationally, emphasizing the need for improved registration and classification guidance [4][5] - Key areas of focus for standardization include artificial intelligence, brain-computer interfaces, and new biological materials, with plans to establish technical organizations for standardization in these fields [5][6] Post-Market Supervision - The NMPA will strengthen post-market supervision requirements for innovative medical devices, encouraging manufacturers to conduct post-market evaluations and real-world studies to enhance product safety and reliability [5][6] - The regulatory framework will also be improved to support companies in expanding their international market presence, including policies related to export sales certification [6]