| 医疗器械注册产品标准复核常见问题分析 |
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| 引用本文： | 颜敏,曹俐,吴明军. 医疗器械注册产品标准复核常见问题分析[J]. 中国医疗器械杂志, 2014, 0(2): 133-135 |
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| 作者姓名： | 颜敏 曹俐 吴明军 |
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| 作者单位： | 湖南省医疗器械与药用包装材料容器检测所,长沙市410001 |
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| 摘 要： | 根据医疗器械注册产品标准编写规范，结合标准复核的工作实践，对医疗器械注册产品标准复核过程中发现的常见问题进行了分析，并提出了相应的建议。旨在规范注册产品标准的编写，加速产品标准化进程，促进行业规范发展。
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| 关 键 词： | 医疗器械 注册产品标准 问题分析 |
Analysis of the Common Problems of Standards During Medical Devices Registration |
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| Yan Min,Cao Li,Wu Mingjun. Analysis of the Common Problems of Standards During Medical Devices Registration[J]. Chinese journal of medical instrumentation, 2014, 0(2): 133-135 |
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| Authors: | Yan Min Cao Li Wu Mingjun |
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| Affiliation: | ( Hunan Testing Institute for Medical Devices ＆ Pharmaceutical Packaging Materials, Changsha, 410001) |
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| Abstract: | According to the registered product standards specification of medical devices, combined with the standard reviewing work, the common problems of standards during medical devices registeration were analyzed and corresponding suggestions were proposed to standardize the standard of the registered product, accelerate the standardization and promote the industry standardized . |
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| Keywords: | medical device registration product standard problem analysis |
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