Analysis of Post-market Supervision and Quality Control Issues and Countermeasures of Medical Devices in China
- VernacularTitle:我国医疗器械上市后监管和质量控制问题与对策分析
- Author:
Chengchen CHU
1
;
Liping MA
;
Bingzhen ZHANG
Author Information
1. 上海交通大学医学院附属第六人民医院 上海 200233
- Publication Type:Journal Article
- Keywords:
medical equipment;
regulation;
quality control;
clinical use management
- From:
Chinese Hospital Management
2025;45(12):14-16
- CountryChina
- Language:Chinese
-
Abstract:
Objective To analyze the current situation,problems and countermeasures of quality control and post-market supervision of medical equipment in China,and provide a reference basis for improving the quality and safety level of medical equipment in China.Methods Through literature research and current situation analysis,the reasons why the clinical use risks of medical equipment in China have not been effectively controlled due to post-market supervision and quality control were discovered,and targeted countermeasures and suggestions were put forward.Results lt targets the problems in the management of medical devices.Specifically,there were issues such as the ineffective implementation of post-market supervision,the lack of overall planning at the national level,and the absence of corresponding regulatory documents and operation guidelines.To address these issues,we ap-proach from three aspects:strengthening supervision,conducting coordinated management,and formulating guide-lines.Specific policy recommendations were as follows:enhance post-market supervision of medical devices to im-prove the effectiveness of medical quality risk prevention and control;establish a national quality control center to comprehensively and coordinately manage the quality of medical devices and promote balanced development;and expedite the formulation of supporting technical standards and operation guidelines,and strengthen the post-mar-ket use evaluation of medical devices.Conclusion The situation of risk prevention and control for the quality and safe-ty of medical equipment is severe and should be given sufficient attention.lt is urgent to strengthen post-market su-pervision and coordinate the quality control of medical equipment to ensure medical quality and safety and promote the healthy development of the medical equipment industry.
