| 医用敷料类医疗器械分类界定工作的研究 |
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| 引用本文： | 徐向彩,余晓芬,郑建,钱文文,梁泽伟. 医用敷料类医疗器械分类界定工作的研究[J]. 中国医疗器械信息, 2022, 0(1): 17-19,47 |
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| 作者姓名： | 徐向彩 余晓芬 郑建 钱文文 梁泽伟 |
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| 作者单位： | 浙江省医疗器械检验研究院;国家药品监督管理局生物医学光学重点实验室;浙江省医疗器械安全性评价研究重点实验室;浙江省药品监督管理局 |
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| 基金项目： | 浙江省药品监管系统科技计划项目(项目名称:浙江省医疗器械分类界定审查机制研究,项目编号:2020023)。 |
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| 摘 要： | 基于医用敷料类产品的发展情况,结合目前监管现状,根据《医疗器械分类目录》和《医疗器械分类规则》等相关法规,对医用敷料类产品的分类界定审查进行探讨和分析,提出了评价的技术建议,供医疗器械监管和技术评价参考.
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| 关 键 词： | 医用敷料 医疗器械 分类界定 |
Researching on the Classification and Definition of Medical Dressings |
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| XU Xiang-cai,YU Xiao-fen,ZHENG Jian,QIAN Wen-wen,LIANG Ze-wei. Researching on the Classification and Definition of Medical Dressings[J]. China Medical Devices Information, 2022, 0(1): 17-19,47 |
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| Authors: | XU Xiang-cai YU Xiao-fen ZHENG Jian QIAN Wen-wen LIANG Ze-wei |
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| Affiliation: | (Zhejiang Institute of Medical Device Supervision Testing,Zhejiang Hangzhou 310018;National Medical Products Administration Key Laboratory of Biomedical Optics,Zhejiang Hangzhou 310018;Zhejiang Provincial Key Laboratory of Safety Evaluation Research of Medical Device,Zhejiang Hangzhou 310018;Zhejiang Provincial Drug Administration,Zhejiang Hangzhou 310012) |
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| Abstract: | Based on the developing situation of medical dress,considering the domestic regulation of medical dress,according to current Medical Device Classification Catalog and Rule and related laws of China Food and Drug Administration(CFDA),this paper investigated and analyzed the classification of the medical devices,and provided technical suggestion on classifying principle of medical dress,for the reference of regulatory and technical departments. |
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| Keywords: | medical dress medical devices classification |
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