国家药监局通过《关于优化全生命周期监管支持高端医疗器械创新发展的举措》,加速高端器械发展
Soochow Securities·2025-06-21 08:34

Investment Rating - The report maintains an "Overweight" investment rating for the pharmaceutical and biotechnology industry [1]. Core Insights - The National Medical Products Administration (NMPA) has accelerated the development of high-end medical devices through measures aimed at optimizing lifecycle regulation, which is expected to significantly support innovation in this sector [6]. - The report highlights the importance of high-end medical devices, including medical robots, advanced medical imaging equipment, artificial intelligence medical devices, and new biological materials, as key products that will shape the future of medical device production [6]. - Specific measures outlined in the report include optimizing special approval processes, improving classification and naming principles, and enhancing post-market supervision, which are crucial for fostering innovation and meeting public health needs [6]. Industry Trends - The report notes a significant focus from the central government on the innovation and development of high-end medical devices, with a clear mandate for regulatory reforms to promote high-quality growth in the pharmaceutical industry [6]. - The NMPA's initiatives are expected to lead to the application of more new technologies, materials, and methods in healthcare, thereby addressing the health needs of the population [6].