| 李海宁,杜晓丹,陈鸿波,杨昭鹏.我国医疗器械标准法规解读和思考[J].中国药事,2019,33(6):655-660 |
| 我国医疗器械标准法规解读和思考 |
| Analysis and Reflection on the Medical Device Standards and Regulations in China |
| 投稿时间：2019-03-29 |
| DOI：10.16153/j.1002-7777.2019.06.008 |
| 中文关键词: 医疗器械 标准 法规 |
| 英文关键词: medical device standard law and regulation |
| 基金项目: |
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| 中文摘要: |
| 目的：为我国医疗器械标准化管理工作提供参考。方法：总结分析我国医疗器械标准管理法规的基本架构，重点解读深化标准化工作改革方案出台后部分相继修订的法规内容，并对其中的差异性变化及标准化发展趋势进行分析。结果与结论：行业标准和国家标准保持了较好的衔接，后续工作建议进一步完善医疗器械标准法规体系架构，建立科学合理的技术标准体系，优化医疗器械标准组织管理体系，研究落实医疗器械标准实施评价机制，逐步实现标准全生命周期的管理。 |
| 英文摘要: |
| Objective:To provide references for standardization management of medical devices in China. Method:The basic framework of medical device standard management laws and regulations in China was summarized and analyzed. The contents of revised laws and regulations after the introduction of the reform plan of deepening standardization work were discussed in depth. The differences and standardization trends were also analyzed. Results and Conclusion:The industry standard and the national standard are in consistency with each other. It is suggested that the framework of medical device standard management laws and regulations system should be further improved, the scientific and reasonable technical standard system should be established, the medical device standard organization management system should be optimized, the medical device standard implementation appraisal mechanism should be studied and implemented in order to gradually realize the standardized entire life cycle management. |
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