医疗器械风险管理是一项保证医疗器械安全有效的重要管理活动,贯穿在全部的医疗器械的寿命过程中,其管理程序标准化,医疗器械风险管理法规是对风险管理进行的一个重要指南。本文对医疗器械风险管理现状进行综述,并对相关的法规进行简要的介绍等。 Medical Device Risk Management is an important management activity to ensure the safety and effectiveness of medical devices. Throughout the life cycle of all medical devices, the management procedures are standardized. The medical device risk management regulations are an important guide to risk management. This article summarizes the status quo of risk management of medical devices and briefly introduces relevant laws and regulations.