3
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1111000000003282XM
北京市东城区市场监督管理局
第一类医疗器械备案新办
1111000000003282XM311104601400001
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0
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东城区市场监管局
110101000000
北京市东城区市场监督管理局
东城区政务服务中心:工作日,09:00-17:00,{延时服务时间:工作日上午08:30-9:00,下午17:00-17:30,(法定节假日除外,延时服务需预约)}
东城区政务服务中心:北京市东城区珠市口东大街12号一层
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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第一类医疗器械备案新办
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