| 医疗器械的标签和使用说明书 |
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| 引用本文： | 吕宏光. 医疗器械的标签和使用说明书[J]. 中国医疗器械信息, 2013, 0(1): 38-43 |
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| 作者姓名： | 吕宏光 |
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| 作者单位： | 上海恩可埃认证有限公司 |
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| 摘 要： | 本文概括性地介绍了中国、美国、欧盟和全球医疗器械协调工作组(GHTF)对医疗器械标签和使用说明书的定义和法规要求,并进行了简单的比较,以便于读者了解各国法规对医疗器械标签和使用说明管理上的不同要求,在确定医疗器械目标市场时给予考虑。
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| 关 键 词： | 医疗器械 标签 标记 使用说明书 |
Label and Instructions for Use for Medical Devices |
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| LV Hong-guang. Label and Instructions for Use for Medical Devices[J]. China Medical Devices Information, 2013, 0(1): 38-43 |
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| Authors: | LV Hong-guang |
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| Affiliation: | LV Hong-guang Shanghai NQA Certification Co.,Ltd(Shanghai 200122) |
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| Abstract: | In this paper, it briefly introduce the requirement to label and instruction for use of Medical Device from SFDA, U.S.FDA, Europe regulation and GHTF harmonized documents. And simply compare and analyse the sameness and differentia among these regulation ＆ documents. Manufacturer should take into account such requirement when determine target market. |
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| Keywords: | medical device label labeling instruction for use |
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