浅谈Ⅱ类重组胶原蛋白创面敷料产品注册监管的思考

Thoughts on Product Registration Supervision of the Second Type of Recombinant Collagen Wound Dressing

重组胶原蛋白为原料的Ⅱ类重组胶原蛋白创面敷料被广泛用于医疗领域。目前国家药监局及国家医疗器械技术审评中心颁布的关于重组胶原蛋白原料及Ⅱ类重组胶原蛋白创面敷料的相关标准及指导原则远不能满足Ⅱ类重组胶原蛋白敷料注册审评、生产质量控制及监管的需求。文章针对Ⅱ类重组胶原蛋白创面敷料注册审评、质量控制及监管等一些问题进行了思考及分析,并提出了建议,以期为医疗器械监管部门的决策提供一定参考。

Type II recombinant collagen wound dressings with recombinant collagen as raw material have been widely used in the medical field.At present,the relevant standards and guidelines issued by the State Food and Drug Administration and National Medical Device Technical Review Center on recombinant collagen raw materials and type II recombinant collagen wound dressings are far from meeting the needs of registration review,production quality control and supervision of type II recombinant collagen dressings.In this paper,some problems such as registration evaluation,quality control and supervision of type II recombinant collagen wound dressings are analyzed,and some suggestions are put forward in order to provide some reference for the decision-making of medical device regulatory departments.