中国医疗器械注册管理工作的现状与思考被引量：13

Situation and Assessment on the Medical Device Registration System in China

下载PDF

导出

摘要对中国医疗器械注册管理工作的现状进行了回顾分析,分析了存在的问题和薄弱环节,并就加强和完善相关工作进行了初步讨论。 The situation and recent progress in medical device registration system in China were reviewed,the existing weakness and challenges were assessed,and the future trend was discussed.

作者王兰明

机构地区国家食品药品监督管理局医疗器械监管司

出处《中国医疗器械信息》 2012年第11期28-34,39,共8页 China Medical Device Information

关键词医疗器械注册薄弱环节改进 medical device registration weakness improvement

分类号 R197 [医药卫生—卫生事业管理]

引文网络
相关文献

参考文献10

1王兰明.中国医疗器械监督管理[J].华夏医药,2003,7(5):63-66. 被引量：4
2孙勤,严梁.欧美医疗器械管理经验及对中国医疗器械法规体系改革的启示[J].中国医疗器械杂志,2006,30(1):43-52. 被引量：26
3http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=notifiedbody.main, 2011-9-30.
4龚声瑾.我国医疗器械许可证审批体系对产业发展的影响[J].中国医疗器械信息,2010,16(4):62-64. 被引量：1
5杨学智、张治国、李海燕,等.中医类医疗器械注册实践的关键[C].全国第十一次中医诊断学术年会论文集,2010:107-123.
6王张明.漫谈医疗器械软件监管.http://www.smianet.com/content.aspx?id= 14297, 2012-3 - 1.
7徐研偌.论医疗器械评价(注册技术审查)的系统性[J].中国医疗器械信息,2011,17(6):46-47. 被引量：16
8张文燕.美国医疗器械审批混沌[J].中国医院院长,2011,7(8):29-29. 被引量：1
9王迪.医疗器械审批体系:宽松而不放任[N].医药经济报,2011,8(5):A04.
10U.S. FDA, Medical Device Innovation Initiative, February 8, 2011.

二级参考文献79

1O'Grady,Smith,J.D.et al.(1999)Medicine,Medical Devices and the Law,Cambridge University Press.
2Ogus,A.I.(1994)Regulation:Legal Form and Economic Theory,Clarendon Press.
3Pieterse,H,et al.(1999)International Medical Device Clinical Investigations:A Practical Approach(Second Edition),Interpharm Press.
4Pollitt,C.et al.(2004)Public Management Reform A Comparative Analysis(Second Edition),Oxford University Press.
5Punch,Maurice(1996)Dirty Business:Exploring Corporate Misconduct,SAGE Publications.
6Ritchie J.et al.(1994)Qualitative data analysis for applied policy research,in Analyzing Qualitative Data(Bryman A.and Burgess R.G,eds),Routledge,London,pp.173-194.
7Schnoll,L.(1997)The CE Mark:Understanding the Medical Device Directive,Paton Press.
8Sedjari,Ali(2004)Public-private partnerships as a tool for modernizing public administration,International Review of Administrative Sciences:An International Journal of Comparative Public Administration,17(2),June 2004.
9Selltiz,et al.(1962)Research Methods in Social Relations(Revised),New York,Holt,Rinehart and Winston.
10State Food and Drug Administration,China www.sfda.gov.cn.