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Zhongguo Yi Liao Qi Xie Za Zhi. 2013 May;37(3):213-7.

[Instruction of the technical evaluation for medical devices kits].

[Article in Chinese]

Author information

  • 1Center for Certification & Evaluation, SHFDA, Shanghai 200020.


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.

[PubMed - indexed for MEDLINE]
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