2
01
111100000000271742
北京市药品监督管理局
《医疗器械生产许可证》延续
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1111000000002717422000172027000
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市药监局
110000000000
北京市药品监督管理局
北京市政务服务中心:法定工作日: 上午: 09:00 - 12:00; 下午: 13:30 - 17:00; {延时服务时间: 工作日上午08:30 - 09:00; 下午17:00 - 17:30; 周六上午09:00 - 13:00; };北京城市副中心政务服务中心:法定工作日: 上午: 09:00 - 12:00; 下午: 12:00 - 17:00; {延时服务时间: 工作日上午08:30 - 09:00; 下午17:00 - 17:30; 周六上午09:00 - 13:00; }
北京市政务服务中心:北京市丰台区西三环南路1号(六里桥西南角)综合窗口
北京城市副中心政务服务中心:北京市通州区新华东街48号二区（东南角）综合窗口
1.依据《医疗器械生产监督管理办法》第十七条 的规定医疗器械生产许可证有效期届满延续的，应当在有效期届满前90个工作日至30个工作日期间提出延续申请。逾期未提出延续申请的，不再受理其延续申请。
原发证部门应当结合企业遵守医疗器械管理法律法规、医疗器械生产质量管理规范情况和企业质量管理体系运行情况进行审查，必要时开展现场核查，在医疗器械生产许可证有效期届满前作出是否准予延续的决定。
经审查符合规定条件的，准予延续，延续的医疗器械生产许可证编号不变。不符合规定条件的，责令限期改正；整改后仍不符合规定条件的，不予延续，并书面说明理由。
延续许可的批准时间在原许可证有效期内的，延续起始日为原许可证到期日的次日；批准时间不在原许可证有效期内的，延续起始日为批准延续许可的日期。2.如企业同时涉及《医疗器械生产许可证》许可事项或登记事项变更，应先办理完成相关变更后再申请《医疗器械生产许可证》延续。
具体受理条件为：1.按照标准查验申请材料，相关材料可以通过联网核查的，无需申请人提供；2.申请事项属于市药监局职权范围，申请材料齐全、符合法定形式的，应当受理申请；3.申请资料存在可以当场更正的错误的，应当允许申请人当场更正；4.申请事项依法不属于市药监局职权范围的，应当即时作出不予受理的决定并告知申请人向有关行政机关申请；5.申请资料不齐全或者不符合法定形式的，应当当场或者在5个工作日内一次告知申请人需要补正的全部内容，逾期不告知的，自收到申请资料之日起即为受理；6.受理或者不予受理医疗器械生产许可申请的，应当出具加盖市药监局专用章和注明日期的受理或者不予受理通知书。
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