2
01
111100000000271742
北京市药品监督管理局
《医疗器械生产许可证》登记事项变更
111100000000271742200017202700001
1111000000002717422000172027000
0
f6cab407-240c-42cf-a98c-927797ecc1f8
1106667c-bf05-4dd4-a8e3-cb1950b78854
2
01
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．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．凡申请材料需提交复印件的，申请人须在复印件上注明日期，加盖企业公章；3．企业提交的《医疗器械生产许可变更申请表》应有法定代表人签字，并加盖企业公章；4.《医疗器械生产许可变更申请表》所填写项目应填写齐全、准确，填写内容应符合以下要求：企业名称、统一社会信用代码、住所、法定代表人等与《营业执照》内容相同；“生产范围”应当按照国家药品监督管理部门发布的医疗器械分类目录和相应体外诊断试剂分类子目录中规定的分类编码和名称填写。
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政务服务> 办事指南

《医疗器械生产许可证》登记事项变更

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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 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．凡申请材料需提交复印件的，申请人须在复印件上注明日期，加盖企业公章；3．企业提交的《医疗器械生产许可变更申请表》应有法定代表人签字，并加盖企业公章；4.《医疗器械生产许可变更申请表》所填写项目应填写齐全、准确，填写内容应符合以下要求：企业名称、统一社会信用代码、住所、法定代表人等与《营业执照》内容相同；“生产范围”应当按照国家药品监督管理部门发布的医疗器械分类目录和相应体外诊断试剂分类子目录中规定的分类编码和名称填写。
办理时间 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; } 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)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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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)【展开】
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基本编码 000172027000 事项编码 1111000000002717422000172027000
业务办理项编码 111100000000271742200017202700001 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
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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．凡申请材料需提交复印件的，申请人须在复印件上注明日期，加盖企业公章；3．企业提交的《医疗器械生产许可证变更申请表》应有法定代表人签字，并加盖企业公章；4.《医疗器械生产许可证变更申请表》所填写项目应填写齐全、准确，填写内容应符合以下要求：企业名称、统一社会信用代码、住所、法定代表人等与《营业执照》内容相同；“生产范围”应当按照国家药品监督管理部门发布的医疗器械分类目录和相应体外诊断试剂分类子目录中规定的分类编码和名称填写；5．申请企业名称变更的，应提交：《北京市依申请政务服务事项告知承诺书》、《医疗器械生产许可变更申请表》、《医疗器械生产许可证》副本、《授权委托书》；6.申请法定代表人变更的，应提交：《北京市依申请政务服务事项告知承诺书》、《医疗器械生产许可变更申请表》、《医疗器械生产许可证》副本、《授权委托书》；7.申请住所变更的，应提交：《北京市依申请政务服务事项告知承诺书》、《医疗器械生产许可变更申请表》、《医疗器械生产许可证》副本、《授权委托书》；8.申请生产范围核减的，应提交：《北京市依申请政务服务事项告知承诺书》、《医疗器械生产许可变更申请表》、《医疗器械生产许可证》副本、《授权委托书》。
线上办理 线下办理
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．凡申请材料需提交复印件的，申请人须在复印件上注明日期，加盖企业公章；3．企业提交的《医疗器械生产许可证变更申请表》应有法定代表人签字，并加盖企业公章；4.《医疗器械生产许可证变更申请表》所填写项目应填写齐全、准确，填写内容应符合以下要求：企业名称、统一社会信用代码、住所、法定代表人等与《营业执照》内容相同；“生产范围”应当按照国家药品监督管理部门发布的医疗器械分类目录和相应体外诊断试剂分类子目录中规定的分类编码和名称填写；5．申请企业名称变更的，应提交：《北京市依申请政务服务事项告知承诺书》、《医疗器械生产许可变更申请表》、《医疗器械生产许可证》副本、《授权委托书》；6.申请法定代表人变更的，应提交：《北京市依申请政务服务事项告知承诺书》、《医疗器械生产许可变更申请表》、《医疗器械生产许可证》副本、《授权委托书》；7.申请住所变更的，应提交：《北京市依申请政务服务事项告知承诺书》、《医疗器械生产许可变更申请表》、《医疗器械生产许可证》副本、《授权委托书》；8.申请生产范围核减的，应提交：《北京市依申请政务服务事项告知承诺书》、《医疗器械生产许可变更申请表》、《医疗器械生产许可证》副本、《授权委托书》。
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