| 浅谈如何做好医疗器械注册工作 |
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| 引用本文： | 彭胜华,黄秀义. 浅谈如何做好医疗器械注册工作[J]. 中国医疗器械信息, 2011, 17(1): 43-45 |
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| 作者姓名： | 彭胜华 黄秀义 |
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| 作者单位： | 1. 广东食品药品职业学院医疗器械系,广州,510520
2. 广东省食品药品监督管理局医疗器械处,广州,510080 |
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| 摘 要： | 本文介绍了我国医疗器械注册的有关法规与要求,并结合笔者自身申报注册经验简要介绍境内二类医疗器械注册的有关程序、要求及注意事项,并对做好相关工作提出建议。
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| 关 键 词： | 二类医疗器械 注册 法规 |
Discussion about the Registration and Declaration of Medical Devices |
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| PENG Sheng-hua,HUANG Xiu-yi. Discussion about the Registration and Declaration of Medical Devices[J]. China Medical Devices Information, 2011, 17(1): 43-45 |
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| Authors: | PENG Sheng-hua HUANG Xiu-yi |
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| Affiliation: | 1 Department of medical devices, Guangdong Food and Drug Vocational College (Guangzhou 510520) 2 Department of Medical Devices, Guangdong Food and Drug Administration (Guangzhou 510080)) |
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| Abstract: | Introduce the laws and legislation on registration and declaration of medical devices, recommend the procedure, requisition, points for attention about the registration and declaration of the class, medical devices in China, talk about how to deal with it. |
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| Keywords: | class medical devices registration laws and legislation |
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