Discussion on Regulatory Risk of in Vitro Diagnostic Reagents in Use.
10.3969/j.issn.1671-7104.2018.01.017
- Author:
Zhe LI
1
;
Haixin JIANG
1
;
Jingke WANG
1
;
Jiefang SHEN
1
Author Information
1. General Enforcement Team of Shanghai Food and Drug Administration, Shanghai, 200233.
- Publication Type:Journal Article
- Keywords:
in vitro diagnostic reagents;
medical institutions;
standardized administration
- MeSH:
Government Regulation;
Indicators and Reagents;
adverse effects;
Risk
- From:
Chinese Journal of Medical Instrumentation
2018;42(1):62-63
- CountryChina
- Language:Chinese
-
Abstract:
According to the information of the supervision and inspection of in vitro diagnostic reagents for clinical use, this article analyzed the compliance issues and discussed the methods to solve the problems, to urge medical institutions to reduce the regulatory risk of in vitro diagnostic reagents in use.
