Comments and suggestions on the medical device standardization system from the view point of medical devices test.
- Author:
Xiaofang YANG
1
;
Chunren WANG
;
Zhaopeng YANG
;
Deyu LI
Author Information
1. School of Biological Science and Medical Engineering, Beihang University, Beijing 100191, China. yxfang@sina.com
- Publication Type:Journal Article
- MeSH:
China;
Device Approval;
legislation & jurisprudence;
Equipment Safety;
standards;
Equipment and Supplies;
standards;
Legislation, Medical;
Prostheses and Implants;
standards
- From:
Journal of Biomedical Engineering
2013;30(3):546-551
- CountryChina
- Language:Chinese
-
Abstract:
Medical device test is a very important step of medical device registration processes and is also a procedure to confirm whether the medical devices comply with applicable standards. The standardization system is imperfect yet in China due to the complexity of medical devices and the specialty of medical device industry. In this circumstance, the medical device standard is not only the important criteria for the medical devices registration, but also an important practical procedure of the medical device registration. This paper reviews the existing questions and also gives some comments and suggestions on the medical device standardization system from the view point of medical device test.
