摘要
依据《重组胶原蛋白类医疗产品分类界定原则》,重组胶原蛋白类产品作为医用敷料应用时,若产品不可被人体吸收且用于非慢性创面,按照第二类医疗器械管理。文章对重组胶原蛋白类敷料产品作为第二类医疗器械管理、审评过程中的难点问题进行分析探讨,以期为申报者和技术审评部门提供参考。
According to the principles for classification and definition of recombinant collagen medical products,recombinant collagen products shall be managed according to class II medical devices,if they cannot be absorbed by the body and be used for non-chronic wounds when used as medical dressings.This paper analyzes and discusses the difficulties in the management and evaluation of recombinant collagen dressing products as the class II medical devices,in order to provide a reference for applicants and technical evaluation departments.
作者
夏慧敏
吴莉
于琦
XIA Hui-min;WU Li YU Qi(Evaluation Center for Jiangsu Medical Products Administration,Jiangsu Nanjing 210000)
出处
《中国医疗器械信息》
2023年第5期4-7,共4页
China Medical Device Information
关键词
重组胶原蛋白
敷料
技术审评
分析探讨
recombinant collagen
medical dressings
technical evaluation
analysis and discussion
