论文部分内容阅读
本刊讯北京市食品药品监督管理局大力推行医疗器械生产日常监管分级管理,有效地提高了医疗器械生产日常监管的效能。面对全市医疗器械行业生产企业多、重点企业多、监管人员少的突出矛盾,在认真总结以往监管工作经验的基础上,原北京市药品监督管理局在2009年就率先将风险管理理念特别是监管风险理念引入医疗器械生产的日常监管,创造性地提出了医疗器械生产日常监管分级管理的监管模式。2011年,在前期试点工作的基础上,原北京市药品监督管理局相继制定了《北京市医疗器械生产企业
The newsletter Beijing Municipal Food and Drug Administration vigorously promote the daily supervision of medical equipment manufacturing management, effectively improve the effectiveness of the daily supervision of the production of medical devices. The face of the city’s medical equipment industry manufacturing enterprises, key enterprises and supervisors less prominent contradictions in the careful summary of previous regulatory experience based on the original Beijing Municipal Drug Administration took the lead in 2009, the concept of risk management, especially The concept of regulatory risk introduces the daily supervision of the production of medical devices and creatively puts forward the regulatory mode of the daily supervision and management of medical devices. In 2011, on the basis of preliminary pilot work, the former Beijing Municipal Drug Administration successively formulated the "Beijing Medical Device Manufacturing Enterprise