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我国医疗器械主文档登记制度研究 被引量:5

Research on Registration System of Medical Device Master Files in China
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摘要 医疗器械主文档登记制度是为解决医疗器械申请人在提供注册申报资料过程中所面临外购或外包服务供应商由于技术保密原因不愿意配合的问题而建立的一种制度。在简要介绍国外监管机构主文档制度的基础上,对创建我国医疗器械主文档登记制度的研究成果进行了论述。研究结果表明,主文档登记制度的建立可以提高医疗器械所涉及外购或外包行为的规范化和便捷化,符合医疗器械行业发展和监管体系发展的需要。同时,该制度的实施引发额外风险的概率较低。因此,预期其为促进公众健康所带来的受益大于风险,具有重要应用价值。 The registration system of medical device Master Files is established to solve the problem that the outsourcing suppliers are not willing to cooperate with the device applicants in the process of providing medical device application documents.After a brief introduction of Master Files systems established by foreign regulatory agencies,this article focuses on the research of establishing a medical device Master Files registration system in China.The results show that the establishment of Chinese Master Files registration system can both improve the standardization and convenience of outsourcing activities of medical devices,and satisfy the needs of the development of medical device industry and regulatory system.At the same time,the probability of additional risk caused by the implementation of the system is low.Therefore,it is expected that the benefits of the system to promote public health outweigh the potential risks,which demonstrates that establishment of the system has important application values.
作者 赵鹏 张书培 史新立 ZHAO Peng;ZHANG Shupei;SHI Xinli(Center for Medical Device Evaluation,NMPA,Beijing,100081)
出处 《中国医疗器械杂志》 2021年第2期205-209,223,共6页 Chinese Journal of Medical Instrumentation
关键词 医疗器械 技术审评 主文档 原材料 监管科学 medical device review master file raw material regulatory science
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