国家药监局扩大医疗器械注册人制度试点北京及上海等21省市参与
国家药品监督管理局发布《关於扩大医疗器械注册人制度试点工作的通知》,进一步扩大医疗器械注册人制度试点,为全面实施医疗器械注册人制度进一步积累经验。
《通知》明确,北京、天津、河北、辽宁、黑龙江、上海、江苏、浙江、安徽、福建、山东、河南、湖北、湖南、广东、广西、海南、重庆、四川、云南、陕西等21个省、自治区、直辖市参加本次医疗器械注册人制度试点。
《通知》明确,参与试点工作的注册人和受托生产企业应当签订委托合同和质量协议,并对产品注册、变更和生产企业许可证办理程序进行了规定,同时强调各级药品监管部门应当加强对注册人履行保证医疗器械质量、上市销售与服务、医疗器械不良事件监测与评价、医疗器械召回等义务情况的监督管理。
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