Discussion on Technical Evaluation Requirements of Allergen Detection Reagent Pre-marketing.
10.3969/j.issn.1671-7104.2022.03.017
- Author:
Xiao-He YANG
1
;
Qin-Fang DONG
1
;
Lan ZHANG
1
;
Yu-Hang WANG
1
;
Wen-Wu ZHU
1
Author Information
1. Zhejiang Center for Medical Device Evaluation (Zhejiang Provincial Center of Medical Device Adverse Events Monitoring), Hangzhou, 311121.
- Publication Type:Journal Article
- Keywords:
allergen;
clinical trial;
gold standard;
performance index;
traceability
- MeSH:
Allergens;
European Union;
Indicators and Reagents;
Marketing;
Reference Standards
- From:
Chinese Journal of Medical Instrumentation
2022;46(3):318-322
- CountryChina
- Language:Chinese
-
Abstract:
In the perspective of technical evaluation, the pre-marketing regulatory requirements of allergen detection reagents in China, America, European Union were compared, and the regulatory risks and performance requirements of this product were analyzed based on the monitoring of post-marketing adverse events, reference standards and domestic and foreign regulatory documents. In view of the "neck-stuck" problems such as the difficulty of clinical trials, the difficulty of finding comparable contrast reagents and the lack of clinical diagnostic gold standards, this paper discusses and gives regulatory suggestions, with a view to providing technical reference for product R&D, production, evaluation, approval and supervision in this field.
