Unannounced inspection,key control points and countermeasures for implantable medical devices
10.19745/j.1003-8868.2025129
- VernacularTitle:植入性医疗器械飞行检查情况、关键控制点及对策分析
- Author:
Hong PAN
1
Author Information
1. 云南省食品药品审核查验中心,昆明 650032
- Publication Type:Journal Article
- Keywords:
implantable medical device;
unannounced inspection;
quality management system;
manufacturing enterprise
- From:
Chinese Medical Equipment Journal
2025;46(7):81-86
- CountryChina
- Language:Chinese
-
Abstract:
Totally 20 manufacturers for implantable medical devices had their unannounced inspection introduced,whose problems and key control pointes were analyzed in terms of plant and facilities,equipment,document management,design and development,procurement,production management and quality control.Some suggestions were put forward including promoting the awareness of the first responsible person of the enterprise,strengthening the competence level of the enterprise personnel and enhancing the ability of the enterprise to operate the quality management system,which were of great significance for enterprises to improve the quality of implantable medical devices.[Chinese Medical Equipment Journal,2025,46(7):81-86]
