医疗器械不良事件监测和再评价_英文.doc

《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 of Medical 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 been reviewed and approved by State Administration for Market Regulation and National Health Commision, and now is 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 Xiaowei 2018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 Device Adverse Events 总 则 Chapter I General Provisions 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 and effectively control the risks of post-market medical devices, and guarantee human health and life safety, the Measures for the Management of the Monitoring and Reevaluation of Medical Device Adverse Events (hereinafter referred to as “the Measures”) is formulated in accordance with the Regulations for the Supervision and Administration of Medical Devices. 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 medical device adverse events carried out within the People’s Republic of China. 医疗器械上市许可持有人（以下简称持有人），应当具有保证医疗器械安全有效的质量管理能力和相应责任能力，建立医疗器械不良事件监测体系，向医疗器械不良事件监测技术机构（以下简称监测机构）直接报告医疗器械不良事件。由持有人授权销售的经营企业、医疗器械使用单位应当向持有人和监测机构报告医疗器械不良事件。 Article 3 Medical device listing approval holder (hereinafter referred to as the holder), shall have the quality management capability and the corresponding responsibility capability to ensure