基于风险分析的创面敷料产品分类监管研究
Study on Classification Supervision of Wound Dressing Products Based on Risk Analysis
刘敏 1高利宏 1韩鸿红 1温莉茵 2王越 2张春青 2汤京龙2
作者信息
- 1. 重庆市药品技术审评查验中心,重庆 401120
- 2. 国家药品监督管理局医疗器械标准管理中心,北京 102629
- 折叠
摘要
目的:为创面敷料类产品类别属性与分类判定提供参考.方法:本文在梳理产品的基础上,从组成成分是否含药、是否可吸收、是否发挥药理作用、接触创面情况等判定要素风险点进行分析.基于综合判定原则,分别探索分析创面敷料产品成分是否被吸收或发挥药理作用的判断方法,并总结分类界定研判规律.结果与结论:创面敷料类产品由于其类别属性与分类判定的复杂性,一直以来是行业内的关注热点和难点.该研究从判定要素角度出发,介绍具体的判定方法,为创面敷料类产品类别属性与分类判定提供技术支撑,助力其科学监管.
Abstract
Objective:To provide references for determining the category attributes and classification of wound dressing products.Methods:On the basis of sorting out the products,this article analyzed the risk points of determining factors such as whether the ingredients contain drugs,whether they are absorbable,whether they exert pharmacological effects,and the way they contact with wounds.Based on the principle of comprehensive judgment,this study explored and analyzed the judgment methods for whether the ingredients of wound dressing products are absorbed or exert pharmacological effects,and summarized the judgment rules of the classification and definition.Results and Conclusion:Due to the complexity of category attributes and classification judgment,wound dressing products have always been a hot and difficult topic in the industry.This study started from the perspective of judgment elements and introduced specific judgment methods,to provide technical support for the category attributes and classification judgment of wound dressing products,and assist in their scientific supervision.
关键词
创面敷料/监管类别/监管属性/综合判定/药理作用/吸收Key words
wound dressings/regulatory categories/regulatory attributes/comprehensive judgment/pharmacological effects/absorb引用本文复制引用
出版年
2024
NETL
NSTL
万方数据