USA approval of high-risk medical device.
- Author:
Yongheng CHANG
1
Author Information
1. China center for pharmaceutical International excharge, Beijing, 100082. cyh0010532@sina.com
- Publication Type:Journal Article
- MeSH:
Device Approval;
legislation & jurisprudence;
Equipment Safety;
United States
- From:
Chinese Journal of Medical Instrumentation
2013;37(2):132-136
- CountryChina
- Language:Chinese
-
Abstract:
During the practice of supervision and management of medical device in different countries, the strict regulatory and needs of the program by the regulations is to be determined by the risk level of the medical equipment. This paper briefly describes the regulatory requirements of the United States to enter the market for high-risk medical device.
