3
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TE1320964875987193
北京市门头沟区市场监督管理局
第二类医疗器械经营备案凭证变更
TE1320964875987193311104601600001
TE13209648759871933111046016000
0
918b31be-795f-4829-be7c-e1a920b43295
6ac0c827-50a8-49c0-a907-7071b110ccac
3
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门头沟区市场监管局
110109000000
北京市门头沟区市场监督管理局
门头沟区政务服务中心:工作日9:00-17:00(法定节假日除外){延时服务时间：工作日早上8:00-9:00,下午17:00-18:00;每周六9:00-15:00，需预约}
门头沟区政务服务中心:北京市门头沟区滨河路72号（综合窗口）综合窗口
第三十条 从事第二类医疗器械经营的，由经营企业向所在地设区的市级人民政府食品药品监督管理部门备案并提交其符合本条例第二十九条规定条件的证明资料。（来源：《医疗器械监管管理条例》）1．备案材料应完整、清晰，要求签字的须签字，逐份加盖企业公章，使用A4纸打印或复印，按照材料顺序装订成册并附有目录； 2．凡备案材料需提交复印件的，申请人须在复印件上注明日期并加盖企业公章； 3．《第二类医疗器械经营备案表》应有法定代表人签字并加盖企业公章； 4．《第二类医疗器械经营备案表》所填写项目应齐全、准确，填写内容应符合以下要求： （1）“企业名称”、“住所”与营业执照相同； （2）“经营场所面积、库房面积”应符合《北京市医疗器械经营监督管理办法实施细则》对相应经营范围的要求；（3）“经营方式”内“批发”、“零售”或“批零兼营”填写逻辑为三选一，另“为医疗器械注册人、备案人和经营企业专门提供运输、贮存服务”可在不选择其他三种经营方式的情况下单独勾选； 5.企业法定代表人、企业负责人、质量管理人员的身份证、学历或者职称证明（法定代表人、企业负责人如不能提供学历证明应提交书面说明）应齐全有效；复印件确认留存，原件退回； 6.同时申请第三类医疗器械经营许可和进行第二类医疗器械经营备案（变更）的，或者已经取得第三类医疗器械经营许可进行第二类医疗器械备案（变更）的，可以免予提交相应资料。材料免予提交情况说明：同时申请办理第三类医疗器械经营许可证（变更）和第二类医疗器械经营备案的，或者已经取得第三类医疗器械经营许可证现申请进行第二类医疗器械经营备案变更的，企业提交材料里除《北京市依申请政务服务事项告知承诺书》和《第二类医疗器械经营备案表》外都是非必须提交；企业只申请第二类医疗器械经营备案变更的，所有材料均为必须提供。
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第二类医疗器械经营备案凭证变更
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