Consideration of Mobile Medical Device Regulation.
- Author:
Liang PENG
;
Pengfei YANG
;
Weigang HE
- Publication Type:Journal Article
- MeSH:
China;
Equipment and Supplies;
standards;
Mobile Applications;
standards
- From:
Chinese Journal of Medical Instrumentation
2015;39(4):272-274
- CountryChina
- Language:Chinese
-
Abstract:
The regulation of mobile medical devices is one of the hot topics in the industry now. The definition, regulation scope and requirements, potential risks of mobile medical devices were analyzed and discussed based on mobile computing techniques and the FDA guidance of mobile medical applications. The regulation work of mobile medical devices in China needs to adopt the risk-based method.
