| 李丽莉,李颖,孙彬裕,卢大伟.医疗器械国家重点实验室申报工作实践与思考[J].中国药事,2020,34(4):424-430 |
| 医疗器械国家重点实验室申报工作实践与思考 |
| Practice and Reflections on the Application of the State Key Laboratory of Medical Devices |
| 投稿时间：2019-08-19 |
| DOI：10.16153/j.1002-7777.2020.04.009 |
| 中文关键词: 食品药品监管 国家重点实验室 申报 评定 医疗器械 科学监管 |
| 英文关键词: food and drug supervision State Key Laboratory application evaluation medical device scientific supervision |
| 基金项目: |
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| 中文摘要: |
| 目的：回顾与总结2018年食品药品监管领域医疗器械国家重点实验室的申报及评定工作，为其他实验室申报国家重点实验室提供借鉴。方法：着力阐述申报资料的准备过程，对评定机构的组成及评定方式进行详细的介绍，深入分析评定指标，并针对重点实验室的建设提出建议。结果与结论：国家重点实验室的申报工作使得实验室自身的软、硬件实力得以全面展示。由于思想上重视，准备工作做得充分、细致，推动了医疗器械重点实验室在运行管理上与时俱进、不断创新，加强了医疗器械重点实验室的全面建设与管理。经过评定工作的历练，医疗器械重点实验室更加充满活力。 |
| 英文摘要: |
| Objective: To review and summarize the application and evaluation of the State Key Laboratory of medical devices in the field of food and drug supervision in 2018, and provide reference for other state key laboratories. Methods: The paper focuses on the preparation process of the application materials, introduces the composition and evaluation methods of the evaluation institutions in detail, analyzes the evaluation indicators in depth, and puts forward suggestions for the construction of key laboratories. Results and Conclusion: The laboratory's software and hardware capabilities are fully demonstrated via the application of the State Key Laboratory. Being attached importance to and with sufficient and detailed preparations, the key laboratory of medical devices has been advancing with the times and continuous innovation in the operation management, and the overall construction and management of key laboratory of medical devices has been strengthened. Through the experience of evaluation work, the key laboratory of medical devices is more energetic. |
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