Understanding and Thinking on America Clinical Evaluation of Medical Devices / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 372-387, 2015.
Article
in Chinese
| WPRIM
| ID: wpr-265613
ABSTRACT
This paper introduces the risk classification and listing way of medical devices in the United States, and according to the contents in various situations, FDA provides the requirements for clinical evaluation. At the same time, through the comparative study on the similarities and differences between USA and our country of the clinical evaluation, the paper puts forward some suggestions.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Reference Standards
/
United States
/
United States Food and Drug Administration
/
Risk Assessment
/
Equipment and Supplies
Type of study:
Etiology study
/
Risk factors
Country/Region as subject:
North America
Language:
Chinese
Journal:
Chinese Journal of Medical Instrumentation
Year:
2015
Type:
Article
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