2
01
111100000000271742
北京市药品监督管理局
《医疗器械生产许可证》许可事项变更
111100000000271742200017202700002
1111000000002717422000172027000
0
f6c2b3e8-5160-4856-9340-52cabf3b616b
1106667c-bf05-4dd4-a8e3-cb1950b78854
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）
如企业同时涉及《医疗器械生产许可证》登记事项变更的，应先办理完成相关变更后再申请《医疗器械生产许可证》许可事项变更。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．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.提交的医疗器械注册证以及产品技术要求应在有效期内； 6.租赁协议、房产证明（或使用权证明）应有效，规划用途或设计用途应当明确可以从事生产活动，不应为“住宅”； 7.涉及生产范围增加或生产地址非文字性变更的有关材料，应符合《医疗器械生产监督管理办法》（国家市场监督管理总局令第53号）第十条的要求； 8.申报材料真实性的自我保证声明、《授权委托书》应由法定代表人签字并加盖企业公章。
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2
2
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政务服务> 办事指南

《医疗器械生产许可证》许可事项变更

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（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 如企业同时涉及《医疗器械生产许可证》登记事项变更的，应先办理完成相关变更后再申请《医疗器械生产许可证》许可事项变更。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．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.提交的医疗器械注册证以及产品技术要求应在有效期内； 6.租赁协议、房产证明（或使用权证明）应有效，规划用途或设计用途应当明确可以从事生产活动，不应为“住宅”； 7.涉及生产范围增加或生产地址非文字性变更的有关材料，应符合《医疗器械生产监督管理办法》（国家市场监督管理总局令第53号）第十条的要求； 8.申报材料真实性的自我保证声明、《授权委托书》应由法定代表人签字并加盖企业公章。
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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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】
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基本编码 000172027000 事项编码 1111000000002717422000172027000
业务办理项编码 111100000000271742200017202700002 进驻大厅类型 政务服务中心
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申请材料总要求申请在生产许可证副本登载车间或者生产线发生重大改造情况的，还应提交：车间或者生产线发生重大改造的情况说明（包括改造原因、发生变化的具体情形等）（原件1份）；改造后的生产场地的相关文件（包括厂区总平面图、主要生产车间布置图等文件），改造涉及特殊生产环境要求的，还应提交改造后的设施、环境的相关文件（如生产过程有洁净级别要求的，应当提供标明功能间及人流物流走向的洁净间布置图和有资质的检测机构出具的洁净间环境检测报告）（复印件1份）；申请人所在地市药监局分局对本次重大改造开展现场核查的《医疗器械生产许可现场核查情况汇总表》复印件；《医疗器械生产监督管理办法》第十条规定中与本次变化相关的材料（复印件或原件1份）。 依据《市场监督管理行政许可程序暂行规定》第三十条第（一）项的规定，申请人申请终止实施行政许可的，需提交由法定代表人签字并加盖公章的终止申请书一份（内容应包括但不限于许可事项受理编号、申请终止的理由等），办理人不是法定代表人本人的还应提供《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
申请材料总要求申请在生产许可证副本登载车间或者生产线发生重大改造情况的，还应提交：车间或者生产线发生重大改造的情况说明（包括改造原因、发生变化的具体情形等）（原件1份）；改造后的生产场地的相关文件（包括厂区总平面图、主要生产车间布置图等文件），改造涉及特殊生产环境要求的，还应提交改造后的设施、环境的相关文件（如生产过程有洁净级别要求的，应当提供标明功能间及人流物流走向的洁净间布置图和有资质的检测机构出具的洁净间环境检测报告）（复印件1份）；申请人所在地市药监局分局对本次重大改造开展现场核查的《医疗器械生产许可现场核查情况汇总表》复印件；《医疗器械生产监督管理办法》第十条规定中与本次变化相关的材料（复印件或原件1份）。 依据《市场监督管理行政许可程序暂行规定》第三十条第（一）项的规定，申请人申请终止实施行政许可的，需提交由法定代表人签字并加盖公章的终止申请书一份（内容应包括但不限于许可事项受理编号、申请终止的理由等），办理人不是法定代表人本人的还应提供《授权委托书》。
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