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11110112MB1618822A
北京市通州区市场监督管理局
第一类医疗器械备案新办
11110112MB1618822A311104601400002
11110112MB1618822A3111046014000
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通州区市场监管局
110112000000
北京市通州区市场监督管理局
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）
第十五条 第一类医疗器械产品备案，由备案人向所在地设区的市级人民政府负责药品监督管理的部门提交备案资料。（来源：医疗器械监督管理条例）
（一）备案资料完整齐备。备案表填写完整。
（二）各项文件除关联文件外均应以中文形式提供。如关联文件为外文形式还应提供中文译本并由代理人签章。根据外文资料翻译的资料，应当同时提供原文。
（三）产品备案资料如无特殊说明的，应当由备案人签章。“签章”是指：备案人盖公章，或者其法定代表人、负责人签名加盖备案人公章。
（四）备案人提交纸质备案资料的，备案资料应当有所提交资料目录，包括备案资料的一级和二级标题，并以表格形式说明每项的页码。
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