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探讨建立国产医疗设备认证制度的必要性与可行性
引用本文:殷萌,;叶慧,;殷衡基.探讨建立国产医疗设备认证制度的必要性与可行性[J].中国医疗器械信息,2014(10):29-31.
作者姓名:殷萌  ;叶慧  ;殷衡基
作者单位:[1]北京电视大学东城工作站,北京100020; [2]中国科学器械公司风险与运营部,北京100088; [3]衡基医院管理与设备信息工作室,北京100164
摘    要:发展振兴国产医疗设备对于实施强国战略具有十分重要的意义。要发展国产医疗设备首先要对什么是国产设备有一个明确的定义。我们以核心技术为标准,定义什么是国产医疗设备。根据这个定义,提出了实施国产医疗设备注册制度的建议和具体实施方案。这一制度的实施必将对发展振兴国产医疗设备起到十分重要的作用。

关 键 词:国产医疗设备  定义  注册  措施  发展

To Explore the Necessity and Feasibility of Establishing Domestic Medical Device Registration System
Institution:YIN Heng-ji, YE Hui, YIN Meng (1 scale based hospital management and equipment inlbrmation studio (Beijing 100164) 2 China scientific instrument company risk and operation Department (Beijing 100088) 3 Beijing TV Uni,,ersity East Station (Beijing 100020))
Abstract:the development and revitalization of the domestic medical equipment is very important for the implementation of the strategy. To the development of domestic medical equipments are domestic equipment has a clear deifnition of what. Our core technology as the standard, the deifnition of what is the domestic medical equipment. According to this deifnition, put forward the implementation of domestic medical device registration system is proposed and the concrete implementation plan. The implementation of this system for development wil revitalize the domestic medical equipment plays an important role.
Keywords:deifnition of domestic  medical  device  registration  measures
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