Analysis of focus points in the review and evaluation of Blood Infusion Devices
10.3969/j.issn.1672-8270.2025.09.027
- VernacularTitle:血液灌流器产品的审评关注点分析
- Author:
Chenghong YE
1
;
Li XIAO
1
;
Yuxi YANG
1
;
Liyu LI
1
;
Juntai ZHU
1
Author Information
1. 国家药品监督管理局医疗器械技术审评中心 北京 100076
- Publication Type:Journal Article
- Keywords:
Hemoperfusion device;
Applied status;
Review and analysis
- From:
China Medical Equipment
2025;22(9):139-142
- CountryChina
- Language:Chinese
-
Abstract:
Hemoperfusion device is widely used in the field of blood purification because of its good adsorption properties to some substances in the body.By combing the principle,structure and other characteristics of the hemoperfusion device,searching the approval status of the currently listed products,this paper summarized the main application fields,application scenarios and research frontiers of the hemopoeia product,combined with the current status of the product declaration and product characteristics,and discussed the main concerns of product review,such as product chemical residue and its risk assessment methods,performance verification,etc.In order to provide reference for the product development of relevant product development institutions and the supervision of regulatory agencies.
