This paper summariz-ed the current situation of Class Ⅱ chitosan dressings,and analyzed issues to be concerned during the registration and evaluation stage,proposed the following views:①Clarify the product classification is the primary issue in registration process;②The raw material control of chitosan is the key to the production quality control;③The unified evaluation scale is of great significance for the registration and post market supervision of these products.
chitosansolid dressingsclass Ⅱ medical devicetechnical evaluation
维普
万方数据
