第二类医用透明质酸钠创面敷料技术审评要点探讨  

Discussion on key points for second type of medical sodium hyaluronate wound dressing

作　　者：陈永霞 朱俊泰 毛瑞奇 石巍 垢德双 Chen Yongxia;Zhu Juntai;Mao Ruiqi;Shi Wei;Gou Deshuang(Tianjin Center for Medical Device Evaluation and Inspection,Tianjin 300191,China;Center for Medical Device Evaluation.NMPA,Beijing 100081,China)

机构地区：[1]天津市医疗器械审评查验中心,天津300191 [2]国家药品监督管理局医疗器械技术审评中心,北京100081

出　　处：《国际生物医学工程杂志》2024年第4期411-414,共4页International Journal of Biomedical Engineering

摘　　要：随着医疗美容行业的发展, 医用透明质酸钠创面敷料的市场需求量逐渐加大, 但目前该产品缺少相应的国家标准, 致使该类产品在质量控制、注册申报资料内容、技术审评要求等方面存在标准不一的情况。主要对医用透明质酸钠创面敷料产品分类进行介绍, 并从注册单元划分、原材料控制、产品性能指标、临床评价等技术审评要点进行探讨。剖析了对该类产品注册申报过程中关键资料审评要求, 以期为生产企业及相关监管机构提供技术参考。With the development of the medical cosmetology industry,the market demand for medical sodium hyaluronate dressing is gradually increasing,but at present the product lacks the corresponding national standards.This problem makes this type of product face the problem of non-uniform standards in the quality control,registration declaration information content,technical review requirements,and other aspects.In this review paper,the classification of medical sodium hyaluronate wound dressing products was introduced,and the key points of the technical review were discussed,involving the division of the registration unit,raw material control,product performance indicators,and clinical evaluation.In addition,the key information review requirements in the process of registration and declaration of such products were analyzed,with a view to providing technical references for manufacturers and relevant regulatory agencies.

关 键 词：透明质酸钠 创面敷料 技术审评 

分 类 号：R318.08[医药卫生—生物医学工程]