Monitoring System of Medical Device Adverse Events in the US and Application of MAUDE Database in Medical Device Registration
10.12455/j.issn.1671-7104.230593
- VernacularTitle:美国医疗器械不良事件监测体系及MAUDE数据库在医疗器械注册申报中的应用
- Author:
Jing WU
1
;
Le JIN
Author Information
1. 国家药品监督管理局医疗器械技术审评中心,北京市,100076
- Keywords:
medical device;
adverse event monitoring;
postmarket surveillance;
registration application
- From:
Chinese Journal of Medical Instrumentation
2024;48(4):451-456
- CountryChina
- Language:Chinese
-
Abstract:
In order to achieve precise risk control of medical devices,it is necessary to establish a scientific evaluation system throughout the entire life cycle of medical devices that focuses on risk identification and risk control.This study summarizes the medical device adverse event monitoring system of the US on regulatory agencies and regulatory law,adverse events reporting forms and time limits,adverse event database,adverse event report analysis and evaluation,as well as adverse event feedback and control.Furthermore,some examples are provided to illustrate the application of the MAUDE database in risk analysis,physical and mechanical performance research,and clinical evaluation of medical device registration and application materials.
