3
10
11110000000057840H
北京市海淀区市场监督管理局
第一类医疗器械生产变更备案
11110000000057840H311104601500001
11110000000057840H3111046015000
0
0a6d97ce-ba17-4fb7-a47a-c8f88a0e243e
dda067a4-ab8a-4f53-b668-94e285682cfb
3
10
海淀区市场监管局
110108000000
北京市海淀区市场监督管理局
海淀区政务服务中心（上地办公区）：全天: 工作日：8:30-17:30（工作日8:30-9:00、17:00-17:30需预约）；周六8:30-12:30（法定节假日除外）需预约；
海淀区政务服务中心（上地办公区）：北京市海淀区东北旺南路甲29号二层西侧综合窗口；
第二十一条 从事第一类医疗器械生产的，由生产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条规定条件的证明资料。（来源：医疗器械监督管理条例）
1、申请材料齐全、规范、真实、有效，材料内容应完整、清晰，与提交的证照证件或批复文件所载内容一致，各材料之间内容一致；
2、申请材料有签字并逐份加盖企业公章；
3、申请人在申请材料复印件上注明日期，加盖企业公章或法定代表人签字或签章；
4、联网核查《营业执照》，应在有效期内，且经营范围应包括医疗器械生产；
5、联网核查申请人已办理的《第一类医疗器械生产备案凭证》；
6、《第一类医疗器械生产备案变更申请表》所填写项目应填写齐全、准确，填写内容应符合以下要求：
（1）统一社会信用代码与联网查询的《营业执照》内容一致；备案编号、备案日期、原备案事项与联网查询的《第一类医疗器械生产备案凭证》内容一致；
（2）变更企业名称、住所、法定代表人的，变更后事项内容应与联网查询的《营业执照》内容一致；
（3）变更生产地址的，变更后生产地址应与提交的租赁协议、房产证明地址一致；
（4）变更生产范围的，变更后生产范围应当按照国家药品监督管理部门发布的第一类医疗器械产品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；
7、变更企业负责人的，提交的企业负责人的身份证明应有效；
8、变更生产地址的，提交的租赁协议、房产证明（或使用权证明）、生产地址文字性变更的相关证明文件应有效，房屋规划用途或设计用途应与医疗器械生产活动相适应，不应为住宅、宅基地等。
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第一类医疗器械生产变更备案
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