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| 中美医疗器械标准管理对比研究与启示 |
| A Comparative Study on the Standard Management of Medical Devices between China and the United States |
| 投稿时间：2020-05-20 修订日期：2020-06-09 |
| DOI： |
| 中文关键词: 医疗器械 标准 标准体系 |
| 英文关键词: Medical devices standard standard system |
| 基金项目: |
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| 中文摘要: |
| 目的 为医疗器械标准体系建设提供技术建议。方法 对中美国家标准及医疗器械标准管理模式对比分析研究。结果与结论 通过中美标准管理模式对比分析,提出完善医疗器械标准体系建设建议,提高医疗器械标准管理水平。 |
| 英文摘要: |
| Objective To provide a technical suggestions for the construction of medical device standard system. Method To study a comparative analysis for the national standard and the medical device management mode between China and the United States. Result and Conclusion By the comparative analysis of the standard management mode between China and the United States, the paper puts forward some suggestions for improving the standard system of medical devices.Its aim is to promote the standard management level for medical device . |
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