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| 新形势下医疗器械标准化体系研究 |
| The study on medical device standardization system under the new situation |
| 投稿时间：2019-06-24 修订日期：2019-09-21 |
| DOI： |
| 中文关键词: 医疗器械 标准体系 标准管理法规 组织架构 |
| 英文关键词: Medical device standardization system standard management regulations organization structure |
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| 中文摘要: |
| 目的：研究在新形势下如何不断完善、构建更好的服务于监管需要和产业发展的医疗器械标准化体系。方法：通过对医疗器械标准化工作面临的新形势、新要求进行分析，从标准管理法规建设、组织架构建设、标准体系建设的角度对医疗器械标准化体系进行研究。结果与结论：通过持续深化标准化工作改革，继续强化医疗器械标准化顶层设计,探索研究医疗器械团体标准管理模式，深入推进医疗器械强制性标准整合精简工作，从而建立适应新形势的更加科学合理、先进适用、开放兼容、规模适度的医疗器械标准化体系。 |
| 英文摘要: |
| Objective To study how to improve and build a medical device standardization system for serving supervision and industrial development under the new situation. Methods The medical device standardization system was dissected by analyzing the new situation and new requirements of medical device standardization based on the construction of standard management regulations, organization structure and standardization system in recent years. Results & Conclusion A more advanced, open and reasonable medical device standardization system will be established by deepening the reform of standardization work continuously, enforcing the top-level design of medical device standardization successively, exploring the management model of group standards for medical devices and further promoting the integration and simplification of mandatory standards for medical devices. |
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