Research and Discussion on the Whole Lifecycle Supervision of Typical Class Ⅱ Wound Dressing Products.
10.12455/j.issn.1671-7104.240550
- Author:
Lan ZHANG
1
;
Ye ZENG
1
;
Xin XIE
1
;
Jiaohui BAO
2
;
Xiaohe YANG
1
;
Weiming QI
1
Author Information
1. Zhejiang Center for Medical Device Evaluation (Zhejiang Provincial Center of Medical Device Adverse Events Monitoring), Hangzhou,
2. Zhejiang Institute of Medical Device Testing, Hangzhou,
- Publication Type:Journal Article
- Keywords:
Class I registration;
adverse event monitoring;
inspection;
risk;
wound dressing
- MeSH:
Bandages/standards*;
United States;
China;
Humans;
European Union
- From:
Chinese Journal of Medical Instrumentation
2025;49(3):344-349
- CountryChina
- Language:Chinese
-
Abstract:
In this study, the pre-market regulatory requirements for typical Class Ⅱ wound dressings, as well as the status of testing and post-market adverse events monitoring, were reviewed from the perspective of the whole lifecycle of medical devices. Additionally, the regulatory requirements for wound dressings in China, the United States, and the European Union were compared. Supplementary research was also conducted on Class Ⅰ and Ⅱ liquid and paste dressing products. Furthermore, this study analyzed the issues in the registration and application of typical Class Ⅱ wound dressings and provided regulatory recommendations, aiming to offer technical references for the review and approval, inspection and testing, and post-market supervision of wound dressing products.
