| 刘敏,高利宏,韩鸿红,温莉茵,王越,张春青,汤京龙.基于风险分析的创面敷料产品分类监管研究[J].中国药事,2024,38(6):640-643 |
| 基于风险分析的创面敷料产品分类监管研究 |
| Study on Classifi cation Supervision of Wound Dressing Products Based on RiskAnalysis |
| 投稿时间：2023-12-01 |
| DOI：10.16153/j.1002-7777.2024.06.005 |
| 中文关键词: 创面敷料 监管类别 监管属性 综合判定 药理作用 吸收 |
| 英文关键词: wound dressings regulatory categories regulatory attributes comprehensive judgment pharmacological eff ects absorb |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| Objective: To provide references for determining the category attributes and classifi cation of wounddressing products. Methods: On the basis of sorting out the products, this article analyzed the risk points ofdetermining factors such as whether the ingredients contain drugs, whether they are absorbable, whether theyexert pharmacological eff ects, and the way they contact with wounds. Based on the principle of comprehensivejudgment, this study explored and analyzed the judgment methods for whether the ingredients of wound dressingproducts are absorbed or exert pharmacological eff ects, and summarized the judgment rules of the classifi cationand defi nition. Results and Conclusion: Due to the complexity of category attributes and classifi cation judgment,wound dressing products have always been a hot and diffi cult topic in the industry. This study started from theperspective of judgment elements and introduced specific judgment methods, to provide technical support forthe category attributes and classification judgment of wound dressing products, and assist in their scientificsupervision. |
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