新形势下医疗器械精准监管的理念
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摘要
传统的医疗器械监管模式存在监管无效等问题。该文强化问题导向,提出了精准监管的理念,旨在保障医疗器械安全有效,促进产业持续健康发展。与传统监管模式相比,精准监管注重监管的有效性,关注有效监管与行业自律、产业发展的关系,具有针对性、有效性、准确性、快捷性和高效率的特点。该文进一步从加强信用管理、智慧监管、专业监管以及促进行业自律、鼓励技术创新六个方面阐述了精准监管的具体实施路径和应注意的问题。
The traditional regulation mode on medical devices has invalid and negative effect problems. In order to more effectively ensure safety and efficacy of medical devices, promote healthy industrial development, this paper puts forward the innovative concept of smart regulation on the basis of problem orientation. Compared with traditional regulatory mode, smart regulation focus on effectiveness, and pays attention to relationship between effective regulation with self-discipline and industrial development, has characteristics of improving pertinence, effectiveness, accuracy, speed and efficiency of regulation. This paper further elaborates implementation approaches and attentions of smart regulation, by the ways of strengthening credit management, intelligent regulation, professional regulation, promoting self-discipline and encouraging innovation.
The traditional regulation mode on medical devices has invalid and negative effect problems. In order to more effectively ensure safety and efficacy of medical devices, promote healthy industrial development, this paper puts forward the innovative concept of smart regulation on the basis of problem orientation. Compared with traditional regulatory mode, smart regulation focus on effectiveness, and pays attention to relationship between effective regulation with self-discipline and industrial development, has characteristics of improving pertinence, effectiveness, accuracy, speed and efficiency of regulation. This paper further elaborates implementation approaches and attentions of smart regulation, by the ways of strengthening credit management, intelligent regulation, professional regulation, promoting self-discipline and encouraging innovation.
引文
[1]医疗器械监督管理条例(中华人民共和国国务院令第6 5 0号)[EB/OL].[2018-07-01].http://www.chinalaw.gov.cn/art/2014/3/31/art_12_89701.html.
[2]福喜难被罚倾家荡产:食药监局7次都没检出问题(人民网)[R/OL].[2018-07-01].http://politics.people.com.cn/n/2014/0725/c1001-25340006.html.
[3]冯寿青.药品安全与数字化监管[D].济南:山东大学,2009.
[4]HAMBURG M A.How smart regulation supports public health and private enterprise[R/OL].[2018-07-04].https://www.ipqpubs.com/wp-content/uploads/2012/02/Hamburg-speech-Feb.6.2012.pdf.
[2]福喜难被罚倾家荡产:食药监局7次都没检出问题(人民网)[R/OL].[2018-07-01].http://politics.people.com.cn/n/2014/0725/c1001-25340006.html.
[3]冯寿青.药品安全与数字化监管[D].济南:山东大学,2009.
[4]HAMBURG M A.How smart regulation supports public health and private enterprise[R/OL].[2018-07-04].https://www.ipqpubs.com/wp-content/uploads/2012/02/Hamburg-speech-Feb.6.2012.pdf.