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中美医疗器械监管科学和立法研讨会召开

2023-12-20 15:31 未知 admin 阅读

据国家药监局网站消息,12月15日下午,中美医疗器械监管科学和立法研讨会在京召开。国家药监局党组成员、副局长徐景和出席会议并讲话。徐景和表示,中国国家药监局高度重视医疗器械监管体系建设,鼓励和支持医疗器械创新发展,截至目前共批准256个创新医疗器械产品上市,公众用械需求不断得到更好满足。希望在中美药监机构合作计划框架下,双方进一步拓展医疗器械合作领域,更好地服务两国人民健康。会上,国家药监局代表介绍了新修订的《医疗器械监督管理条例》实施情况以及中国医疗器械标准建设情况。美国食品药品管理局(FDA)驻华办代表介绍了美国医疗器械相关法律法规和立法程序,以及医疗器械监管科学重点领域和具体问题。

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