Instruction of the technical evaluation for medical devices kits.
- Author:
Zhizhen ZHONG
1
;
Hong QIAN
;
Yungao CHU
;
Siwei DAI
;
Ze WANG
;
Yingfeng ZHU
;
Xuying SUN
Author Information
1. Center for Certification & Evaluation, SHFDA, Shanghai 200020. zhongzhizhen@smda.gov.cn
- Publication Type:Journal Article
- MeSH:
Equipment and Supplies;
standards
- From:
Chinese Journal of Medical Instrumentation
2013;37(3):213-217
- CountryChina
- Language:Chinese
-
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.
