Comparison of Classiifcation and Regulation of in Vitro Diagnostic Products for Clinical Pathology in China and Foreign Country
10.3969/j.issn.1671-7104.2017.02.014
- VernacularTitle:病理用体外诊断试剂国内外分类和监管比较
- Author:
Dawei SHI
1
;
Donglai LIU
;
Ying HUANG
;
Chuntao ZHANG
Author Information
1. 中国食品药品检定研究院
- Keywords:
immunohistochemistry;
in situ hybridization;
classification;
analyte specific reagent;
laboratory developed test
- From:
Chinese Journal of Medical Instrumentation
2017;41(2):127-132
- CountryChina
- Language:Chinese
-
Abstract:
The classification and the regulatory requirement among U.S., E.U., Japan and China were summarized and compared for the immunohistochemistry and in situ hybridization products. The results indicate that: the regulatory classifications of the related products are higher in Japan and China, than U.S.and E.U.; the classification and regulatory requirement are adjusted more flexibly in the centralized system. The difference was discussed and accordingly some suggestions and implications were given for the China's regulation.
