中国人类辅助生殖技术用医疗器械的产业和监管现状  

The Status of Industry and Supervision of Medical Devices for Human Assisted Reproductive Technology in China

作　　者：孙雪[1] 韩倩倩[1] SUN Xue;HAN Qianqian(National Institutes for Food and Drug Control,Beijing,102629)

机构地区：[1]中国食品药品检定研究院,北京市102629

出　　处：《中国医疗器械杂志》2021年第6期591-593,598,共4页Chinese Journal of Medical Instrumentation

基　　金：中国科学院“器官重建与制造”战略性先导专项(XDA16040602)。

摘　　要：综述了辅助生殖技术用医疗器械的国内产业现状、产品种类、产品分类管理现状、技术审评现状、质量评价技术进展和标准化工作进展等。我国辅助生殖技术用医疗器械国内产业初具雏形,标准化工作和监管技术也已打下了坚实的基础,这些都将成为辅助生殖用医疗器械后续发展的重要动力和保障。在新发展理念的指导和加快构建国内大循环主体的趋势下,我国自主可控的辅助生殖用医疗器械产业蓄势待发。This study summarizes the status of domestic industries of medical devices for assisted reproductive technology,product category,the status of product classification management,the status of technical review,the progress of quality evaluation technology,and the progress of standardization.The domestic industry of medical devices for assisted reproductive technology in my country has begun to take shape,and a solid foundation has been laid for standardization and supervision technology.These will become an important driving force and guarantee for the subsequent development of medical devices for assisted reproductive technology.Under the guidance of the new development concept and the trend of accelerating the construction of the main body of the domestic cycle,my country's independent and controllable assisted reproductive medical device industry is gaining momentum.

关 键 词：人类辅助生殖技术 医疗器械 产业现状 监管政策 

分 类 号：F203[经济管理—国民经济] R318[医药卫生—生物医学工程]