2019年,国家药品监督管理局持续推进《医疗器械监督管理条例》修订工作,推进法规制度建设,定期开展由多部门参与的医疗器械上市后监管风险会商,强化高风险产品监管,综合运用不良事件监测和监督抽检、飞行检查等多种手段,切实防控医疗器械质量安全风险,强化医疗器械上市后产品质量监管。2020年为进一步提升医疗器械上市后监管能力,建议加快推进法规制度建设、探索建立风险会商工作机制、深化医疗器械专项整治、加强疫情防控医疗器械质量监管、优化抽检工作程序、推进完善不良事件监测体系等。
<<In 2019,the State Drug Administration continued to promote the revision of the Regulations on the Supervision and Administration of Medical Devices,promote the construction of the regulation system,regularly carry out the post-listing supervision and consultation of medical devices with the participation of many departments,strengthen the supervision and control of high-risk products,comprehensively apply various means such as the monitoring and sampling inspection of adverse events,effectively prevent and control the safety risks of medical devices,strengthen the supervision and control of the quality of medical devices after market. In 2020,strengthen the construction of the construction of the construction of medical devices will be further enhance the construction of the construction of the construction of special supervision and regulation of medical devices
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