2020年,国家药品监督管理局认真学习贯彻党中央国务院重大决策部署,贯彻落实《医疗器械监督管理条例》,进一步深化医疗器械审评审批制度改革,贯彻“四个最严”的要求,既抓疫情防控,又抓质量监管。创新审批成果更加显著,注册人制度试点持续深化,落实“放管服”改革要求更加积极,医疗器械注册管理工作取得新成效。未来我国医疗器械审批制度改革应重点围绕加快医疗器械注册管理法规制修订、全面实施医疗器械注册人制度、继续优化“最严谨的标准”工作体系、持续提高医疗器械分类管理水平等方面展开。
<<In 2020,National Medical Products Administration(NMPA)will conscientiously study and implement the major decisions and plans of the Party Central Committee and the State Council,implement the “Regulations on the supervision and administration of medical devices”,take deepening the reform of the review and approval system of medical devices as the main line,and take the “four most stringent” requirements as the fundamental guidance,so as to grasp the epidemic prevention and control and quality supervision on one hand. The results of innovative examination and approval are more remarkable,the pilot of the registrant system continues to deepen,the requirements of “release,management and service” are more actively implemented,and new achievements have been made in the management of medical device registration. This report introduces the reform progress of China’s medical device approval system in 2020.
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