| 浅谈医疗器械标准制修订需注意的问题 |
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| 引用本文： | 郑佳,余新华. 浅谈医疗器械标准制修订需注意的问题[J]. 中国标准化, 2012, 0(7): 100-102 |
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| 作者姓名： | 郑佳 余新华 |
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| 作者单位： | 中国食品药品检定研究院,国家食品药品监督管理局医疗器械标准管理中心 |
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| 摘 要： | 本文根据标准制修订的相关法规和规定,结合在医疗器械行业标准审查过程中发现的一些问题,对医疗器械标准制修订需注意的要点进行了初步探讨。
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| 关 键 词： | 医疗器械 标准制修订 |
Preliminary Discussion on the Enactment and Amendment of Medical Device Standards |
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| ZHENG Jia , YU Xin-hua. Preliminary Discussion on the Enactment and Amendment of Medical Device Standards[J]. China Standardization, 2012, 0(7): 100-102 |
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| Authors: | ZHENG Jia YU Xin-hua |
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| Affiliation: | (National Institutes for Food and Drug Control, Center for Medical Device Standardization Administration, SFDA) |
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| Abstract: | With the practice of medical device standard review, some main points in the enactment and amendment of standards have been discussed in accordance with relevant laws and regulations. |
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| Keywords: | medical device standard enactment and amendment |
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