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| 新版《医疗器械监督管理条例》中行政改革思路读解 | |
| 引用本文： | 岳伟. 新版《医疗器械监督管理条例》中行政改革思路读解[J]. 中国医疗器械杂志, 2014, 0(5): 357-360 |
| 作者姓名： | 岳伟 |
| 作者单位： | 上海市食品药品监督管理局,上海市200010 |
| 摘 要： | 该文从学习解读新版《医疗器械监督管理条例》出发，梳理了《条例》中体现的行政改革思路．提出了“十大原则”的思路，即全程监管的原则：分级监管的原则：风险分类的原则：安全有效节约原则；鼓励创新的原则：简化许可的原则：科学规范的原则：诚信自律的原则；监管明责的原则：违法严处的原则。并就此进行了讨论。 |
| 关 键 词： | 医疗器械监督管理条例 行政改革 |
Administrative Reform Thinking on the Regulations on the Supervision and Administration of Medical Devices |
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| Yue Wei. Administrative Reform Thinking on the Regulations on the Supervision and Administration of Medical Devices[J]. Chinese journal of medical instrumentation, 2014, 0(5): 357-360 | |
| Authors: | Yue Wei |
| Affiliation: | Yue Wei (Shanghai Food and Drug Administration, Shanghai, 200010) |
| Abstract: | This paper learned and interpreted the regulations on the supervision and administration of medical devices, carded the thoughts of administrative reform, then put forward the ＂ten principles＂, including full supervision, classification supervision, risk classification, safety-effective-save, to encourage innovation, simplified license, scientific-standard, sincerity ＆ self-discipline, clear responsibility, severe punishment, and discussed these priciples. |
| Keywords: | regulations on the supervision and administration of medical devices administrative reform |
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