2
01
111100000000271742
北京市药品监督管理局
《医疗器械生产许可证》补发
1111000000002717422110146026000
0
392736fc-da71-4f50-8631-1ffc2ebca915
caba993c-7dcc-49b7-bc0f-4c2f926ae459
2
01
市药监局
110000000000
北京市药品监督管理局
工作日8:30-17:30（8:30-9:00、12:00-13:30、17:00-17:30为延时服务时间）、周六9:00-13:00（周六为延时服务时间，需预约办理）、法定节假日不对外服务。
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)(1-3层综合窗口) 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）
医疗器械生产许可证遗失的，应当向原发证部门申请补发。原发证部门应当及时补发医疗器械生产许可证，补发的医疗器械生产许可证编号和有效期限与原许可证一致。
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政务服务> 办事指南

《医疗器械生产许可证》补发

北京市

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    到现场次数

  • 20工作日

    法定办结时限

  • 0.5工作日

    承诺办结时限

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办件承诺办结时限说明：（承诺时限为办理流程中“审查与决定”环节的计时时限）

办件承诺办结时限说明：

（承诺时限为办理流程中“审查与决定”环节的计时时限）

基本信息申请材料办理流程结果名称及样本设定依据收费标准及依据常见问题

基本信息

实施主体 北京市药品监督管理局 服务对象
事项类型 行政许可 办理形式
受理条件 医疗器械生产许可证遗失的，应当向原发证部门申请补发。原发证部门应当及时补发医疗器械生产许可证，补发的医疗器械生产许可证编号和有效期限与原许可证一致。
办理时间 工作日8:30-17:30（8:30-9:00、12:00-13:30、17:00-17:30为延时服务时间）、周六9:00-13:00（周六为延时服务时间，需预约办理）、法定节假日不对外服务。 查看详情
办理地点 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)(1-3层综合窗口) 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） 查看详情
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咨询电话：

(010)89150290【展开】

咨询窗口地址：

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)(1-3层综合窗口) 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）【展开】
投诉监督方式
基本编码 110146026000 事项编码 1111000000002717422110146026000
业务办理项编码 111100000000271742211014602600001 进驻大厅类型 政务服务中心
权力来源 法定本级行使 网上支付 否
所属机构 北京市药品监督管理局 委托部门 无
联办机构 无 实施主体性质 法定机关
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行使层级 市级 运行系统 市级自建（垂管）
物流快递 是 办理方式 自办件
预约办理 数量限制 无
中介服务 无 权限划分 无
通办范围 全市 特别程序 无
行使内容 无
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申请材料总要求1.申请材料应完整、清晰，要求签字的须签字，每份加盖企业公章，使用A4纸打印或复印； 2.企业提交的《医疗器械生产许可证补发申请表》应有法定代表人签字并加盖公章； 3.《授权委托书》应有法定代表人签字并加盖企业公章。
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序号 材料名称 材料来源 材料
必要性		 数量要求 介质要求 表格及样例
下载		 受理标准 提供材料
依据		 其他要求
申请材料总要求1.申请材料应完整、清晰，要求签字的须签字，每份加盖企业公章，使用A4纸打印或复印； 2.企业提交的《医疗器械生产许可证补发申请表》应有法定代表人签字并加盖公章； 3.《授权委托书》应有法定代表人签字并加盖企业公章。
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