title: [Instruction of the technical evaluation for medical devices kits].
abstract: 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.
authors.affiliation: Center for Certification & Evaluation, SHFDA, Shanghai 200020. zhongzhizhen@smda.gov.cn
authors.forename: Zhizhen
authors.initials: Z
authors.lastname: Zhong
authors.forename: Hong
authors.initials: H
authors.lastname: Qian
authors.forename: Yungao
authors.initials: Y
authors.lastname: Chu
authors.forename: Siwei
authors.initials: S
authors.lastname: Dai
authors.forename: Ze
authors.initials: Z
authors.lastname: Wang
authors.forename: Yingfeng
authors.initials: Y
authors.lastname: Zhu
authors.forename: Xuying
authors.initials: X
authors.lastname: Sun
mesh_terms: D004864:Equipment and Supplies / Q000592:standards*