Instruction of the technical evaluation for medical devices kits

Recent years, the development of medical devices kits is rapid. How to make the technical evaluation of medical devices kits more perfect bases on the two major principles of safe and effective, and to make kits in the market more normative and orderly, these issues for technical evaluation have to...

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Bibliographic Details
Published in:	Zhongguo yi liao qi xie za zhi Vol. 37; no. 3; p. 213
Main Authors:	Zhong, Zhizhen, Qian, Hong, Chu, Yungao, Dai, Siwei, Wang, Ze, Zhu, Yingfeng, Sun, Xuying
Format:	Journal Article
Language:	Chinese
Published:	China 01-05-2013
Subjects:	Equipment and Supplies - standards
Online Access:	Get more information
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Summary:	Recent years, the development of medical devices kits is rapid. How to make the technical evaluation of medical devices kits more perfect bases on the two major principles of safe and effective, and to make kits in the market more normative and orderly, these issues for technical evaluation have to be considered. This article makes a study on current situation of production, classification of management and registration status, combined with existing regulations and related standards, and discusses technical evaluation related issues.
ISSN:	1671-7104