医疗器械不良事件监测和再评价_英文VIP专享

《医疗器械不良事件监测和再评价管理办法》（国家市场监督管理总局令第1号）Measures for the Management of the Monitoring and Reevaluation ofMedical Device Adverse Events(Decree No.1 by State Administration for Market Regulation)2018年08月31日 发布Released on August 31, 2018《医疗器械不良事件监测和再评价管理办法》已经国家市场监督管理总局和国家卫生健康委员会审议通过，现予公布，自2019年1月1日起施行。Measures for the Management of the Monitoring and Reevaluation of Medical Device Adverse Events has beenreviewed and approved by State Administration for Market Regulation and National Health Commision, and nowis promulgated and effective as of January 1, 2019.国家市场监督管理总局局长：张茅Director General of State Administration for Market Regulation: Zhangmao国家卫生健康委员会主任：马晓伟Director of National Health Commision: Ma Xiaowei2018年8月13日August 13, 2018医疗器械不良事件监测和再评价管理办法Measures for the Management of the Monitoring and Reevaluation of Medical DeviceAdverse Events第一章总 则Chapter IGeneral Provisions第一条为加强医疗器械不良事件监测和再评价，及时、有效控制医疗器械上市后风险，保障人体健康和生命安全，根据《医疗器械监督管理条例》，制定本办法。Article 1 In order to strengthen the monitoring and reevaluation of medical device adverse events, timely andeffectively control the risks of post-market medical devices, and guarantee human health and life safety,theMeasures for the Management of the Monitoring and Reevaluation of Medical Device Adverse Events (hereinafterreferred to as “the Measures”) is formulated in accordance with the Regulations for the Supervision andAdministration of Medical Devices.第二条在中华人民共和国境内开展医疗器械不良事件监测、再评价及其监督管理，适用本办法。Article 2 The Measures shall apply to the monitoring, reevaluation and supervision and management of med...