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谢伏瞻
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李培林
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    我国从生产企业角度看医疗器械合同开发和生产组织模式(2012~2018)

    摘要

    2017年10月,医疗器械注册人制度出台并落地实施,现已成为我国医疗器械监管领域的重大改革举措。截至2019年4月,医疗器械注册人制度已在上海、广东、天津和北京四个省、直辖市中的六个城市中实施,并在上海和广东两地陆续完成数个产品的医疗器械注册人制度下的产品注册证发放。医疗器械注册人制度强化了医疗器械全生命周期责任管理的概念,解除了现有医疗器械监管法规下医疗器械注册与生产一体的关系,对于我国医疗器械产业的转型和升级有十分显著的促进作用。未来,医疗器械注册人制度将被《医疗器械监督管理条例》所承载,成为我国医疗器械监管最高上位法的内容之一。

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    Abstract

    Since October 2017,The MAH of Medical Device has been introduced and put into effect rapidly,which has become a major reform measure in the supervision of medical devices in China. As of April 2019,The MAH of Medical Device has been implemented in six cities of Shanghai,Guangdong,Tianjin and Beijing,and the product registration certificates of several products have been issued under The MAH of Medical Device in Shanghai and Guangdong. The MAH of Medical Device strengthens the concept of life cycle responsibility management of medical devices,breaks the binding relationship between medical device registration and production,and will greatly promote the transformation and upgrading of China’s medical device industry. In the future,The MAH of Medical Device will be carried by the Regulations on the Supervision and Administration of Medical Devices,and become one of the contents of the Supreme Superior Law of Medical Devices Supervision in China.

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    Keywords: Medical DeviceCDMOMAH
    作者简介
    谭传斌:谭传斌,深圳迈瑞生物医疗电子股份有限公司技术法规专家。
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