Discussion on Current Registration Situation and Problems of in Vitro Dignostic Device of Tumor Marker
10.3969/j.issn.1671-7104.2015.05.016
- VernacularTitle:肿瘤标志物检测试剂注册现状分析与问题探讨
- Author:
Zhaozhao HAN
1
Author Information
1. 国家食品药品监督管理总局医疗器械技术审评中心
- Keywords:
tumor marker;
registration;
novel tumor markers;
technical review;
combined detection
- From:
Chinese Journal of Medical Instrumentation
2015;(5):361-362
- CountryChina
- Language:Chinese
-
Abstract:
This paper aims to analysis of the general problem in the registration dossier and make recommendations on in vitro diagnostic device of tumor markers. On the basis of introducing declarations of the reagents, analysis registration dossier common problems occurs in the products intend to detect novel tumor markers and the combined detection product for multiple tumor markers, and analysis the special requirements for such products.
