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医疗器械注册管理的有效期是多久?
释义
法律分析:根据《医疗器械监督管理条例》规定,医疗器械注册证书的有效期为5年。在证书有效期内,注册人需要向注册管理机构申请变更相关信息或进行复核,以确保注册证书的有效性。过期未重新注册或未根据规定进行变更或复核的,其注册证书即失效。 法律依据:《医疗器械监督管理条例》 第六条 医疗器械注册证书的有效期为5年。到期后,应当按照规定办理变更登记或者复核工作。逾期未办理变更登记或者复核的,医疗器械注册证书失效。
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