|
|
|
| Medical Devices Standardization System in China |
| YANG Xiao-fang1, WANG Chun-ren2, LI De-yu1 |
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.
|
|
Received: 20 March 2018
|
|
|
|
Corresponding Authors:
YANG Xiao-fang. E-mail: yxfang@sina.com
|
|
|
|
[1] Dong Fang.Several points on medical device standards technical committee management[J]. Chinese Drug Waring, 2010, 7(4):211-213.
[2] Mu Ruihong, Xiao Yimei.Present situation and suggestion on Chinese medial device standards[J]. Chinese Pharmacy, 2011, 7:29-31.
[3] China Food and Drug Administration. Administrative measures on medical device standards[EB/OL].[2002-06-15]. http: eng.sfda.gov.cn/ws03/CL0757.
[4] Investigation of the present situation of China medical device standards[J]. Chinese Journal of Medical Device, 2009, 33(5):362-368.
[5] China Food and Drug Administration. Measures for the administration of medical device registration[EB/OL]. [2014-06-30]. http: eng.sfda.gov.cn
[6] Xu Wei.Present situation and suggestion on Chinese medial device registration product standards[J]. China Medical Device Information, 2010, 16(4):52-55.
[7] Standardization Administration of the People's Republic of China. Standardization Law of People's Republic of China [EB/OL].[2017-11-04]. http: www.sac.gov.cn/sbgs/. |
| [1] |
Li Baoming, Hu Jiarui, Xu Haijun, Wang Cong, Jiang Yanni, Zhang Zhihong, Xu Jun. Deep Cascaded Network for Automated Detection of Cancer MetastasisRegion from Whole Slide Image of Breast Lymph Node[J]. Chinese Journal of Biomedical Engineering, 2020, 39(3): 257-264. |
| [2] |
Xu Jie, Wang Xunheng, Li Lihua. Investigating Brain Networks for ADHD Children Based on Phase Synchronization of Resting State fMRI[J]. Chinese Journal of Biomedical Engineering, 2020, 39(3): 265-270. |
|
|
|
|
