1. Beijing University of Aeronautics and Astronautics/School of Biological Science and Medical Engineering, Beijing 100083, China 2. National Institutes for Food and Drug Control/Center of Medical Device,Beijing 102629, China
Abstract：The standardization system is imperfect since the complexity of the medical devices and the specialty of the medical device industry in China. This paper describes the present situation of medical devices standardization system in China, reviews and discusses the advantages and problems of the medical devices standardizatiom. It also presents some comments and suggestions to perfect the medical devices standardization system for enhancing the quality control of medical devices and for promoting the development of medical devices industry.
. [J]. 中国生物医学工程学报(英文版）, 2018, 27(2): 87-91.
YANG Xiao-fang, WANG Chun-ren, LI De-yu. Medical Devices Standardization System in China. Chinese Journal of Biomedical Engineering, 2018, 27(2): 87-91.
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