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备案新办
11110000000057840H311104601500002
11110000000057840H3111046015000
0
6ea1e2e7-3075-45c3-abb9-86e18868c928
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）：法定工作日: 上午: 09:00 - 12:00; 下午: 13:30 - 17:00; (延时服务时间: 工作日上午08:30 - 09:00; 中午12:00 - 13:30; 下午17:00 - 17:30; 周六上午08:30 - 12:30; )；
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、申请材料应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、《第一类医疗器械生产备案表》所填写项目应填写齐全、准确，填写内容应符合以下要求：
（1）企业名称、统一社会信用代码、住所、法定代表人、注册资本、成立日期、营业期限等按照营业执照内容填写；
（2）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；
（3）生产地址应与租赁协议、房产证明地址一致；
5、《营业执照》应在有效期内，且经营范围应包括医疗器械生产；
6、法定代表人、企业负责人的身份证明应有效；
7、生产、质量和技术负责人的身份、学历或职称证明应有效；
8、 租赁协议、房产证明（或使用权证明）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；
9、提交质量手册目录、程序文件目录（主要应包括采购、验收、生产过程、产品检验、入库、出库、质量跟踪、用户反馈、不良事件监测和质量事故报告制度等）。
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