Objective: To investigate the quality management perspective that based on medical devices Good Manufacture Practice (GMP). Methods: To discuss and analyze the definition, research background, current medical equipment quality management system status in China and the value of implementing medical devices GMP. Results: The medical quality management system improvement not only based on the rules setting on quality management in every stage, but also applied during risk management. Conclusion: Chinese medical equipment quality management is a dynamic development system that being a gradual process. The medical devices GMP implementing can provide a good opportunity for the development of medical equipment quality management system and promote overall development.%目的:从医疗器械良好生产规范(GMP)角度探讨医疗器械质量管理.方法:对我国医疗器械GMP的定义、研究背景、目前医疗器械质量管理体系现状以及在质量管理体系中实施医疗器械GMP的价值等方面进行分析探讨.结果:医疗器械质量管理体系的完善除需制定各个环节质量管理规定外,还需在风险管理过程中实施,风险管理为重要组成部分.结论:我国医疗器械质理管理体系属于运态发展阶段,有一个循序渐进的发展过程,随着医疗器械GMP的实施,将为医疗器械质量管理体系的快速发展铺平道路,使整体得到全面的发展.
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