| 张辉,许慧雯,余新华.以创新思路强化医疗器械标准管理[J].中国药事,2021,35(9):967-971 |
| 以创新思路强化医疗器械标准管理 |
| Strengthening the Management of Medical Device Standards with Innovative Ideas |
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| DOI：10.16153/j.1002-7777.2021.09.001 |
| 中文关键词: 医疗器械 标准 监督管理 |
| 英文关键词: medical devices standards supervision and management |
| 基金项目: |
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| 中文摘要: |
| 目的：为贯彻落实新修订的《医疗器械监督管理条例》要求，创新思路强化医疗器械标准管理。方法：比对了新、旧《医疗器械监督管理条例》中医疗器械标准有关条款内容，分析了医疗器械标准体系现状，围绕《医疗器械监督管理条例》要求，提出医疗器械标准体系建设的思路和建议。结果与结论：要切实维护标准的法律地位，优化强制性标准，加强标准制修订管理，强化标准实施监督和标委会管理。 |
| 英文摘要: |
| Objective: To implement the requirements of the newly-revised "Regulations on the Supervision and Administration of Medical Devices", innovative ideas were put forward to strengthen the management of medical device standards. Methods: The relevant terms of medical device standards in the previous and current regulations were compared, and the current situation of the medical device standards' system was analyzed. Based on the requirements of the "Regulations on the Supervision and Administration of Medical Devices", the thoughts and suggestions for the construction of the medical device standards' system were put forward. Results and Conclusion: It is necessary to effectively maintain the legal status of medical device standards, optimize mandatory standards, strengthen the management of making and modifying standards, and enhance the supervision of the implementation of standards and the management of standardization committees. |
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