人类辅助生殖技术用液产品的审评思考  

Thoughts on Evaluation of Culture Medium for HumanAssisted Reproduction Technology

作　　者：许耘 XU Yun(Center for Medical Device Evaluation,NMPA,Beijing,100081)

机构地区：[1]国家药品监督管理局医疗器械技术审评中心,北京市100081

出　　处：《中国医疗器械杂志》2024年第4期457-460,466,共5页Chinese Journal of Medical Instrumentation

摘　　要：人类辅助生殖技术用液作为辅助生殖技术微环境的直接体现者,其安全有效性的评估尤为重要。该研究从辅助生殖技术用液产品的分类管理、技术审评要点、临床评价及审评思考等方面进行探讨,着重从基本要求、原材料控制、生物学评价、灭菌工艺等方面对辅助生殖技术用液产品的审评要点进行梳理,并结合某些物质限量、新型添加物质以及质量体系控制等内容深入思考辅助生殖技术用液产品全生命周期的管理风险。As the direct microenvironment of assisted reproductive technology,the evaluation of culture medium for human assisted reproduction technology is particularly important.This paper discussed the classification management,technical review points,clinical evaluation and review thinking,focusing on the basic requirements,raw material control,biological evaluation,sterilization process of culture medium for human assisted reproduction technology,combined with some material limit,new added material and quality system control to thoroughly assess management risk of the whole life cycle of culture medium for human assisted reproduction technology.

关 键 词：人类辅助生殖技术用液 技术审评要点 临床评价 

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