文档介绍：申请医疗器械注册证流程细解
of rural drinking water sources, protection of drinking water sources in rural areas by the end o申请事务的人员应当受生产企业委托，应提交生产企业负责人身份证
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
明原件与复印件(生产企业负责人办理时);或者生产企业出具的本企业注册申请事务办理人员的授权书及该办理人身份证明原件与复印件(非生产企业负责人办理时)，身份证明原件经核对后退回。
7、如某项申请材料符合国家食品药品监督管理局《医疗器械注册管理办法》中相关豁免条款的规定，或符合国家局其他相关文件规定的，应提交相应的说明文件。
8、本指南已明确要求提交原件的，不得提交复印件。凡申请材料需提交复印件的，申请人(单位)须在复印件上注明“此复印件与原件相符”字样或者文字说明，注明日期，加盖单位公章。
注1：企业应自行保存1份注册申报资料复印件以便注册核查用。(若注册申请未获批准，整套注册申报资料不予退还，申请人可凭复印件申请换回原件。)
(二)申报资料的具体要求：
1、医疗器械注册申请表
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
(1)应有法定代表人签字并加盖公章，所填写项目应齐全、准确;
(2)“生产企业名称”、“注册地址”与《工商营业执照》相同;
(3)“产品名称”、“规格型号”与所提交的产品标准、检测报告等申请材料中所用名称、规格型号一致。
2、医疗器械生产企业资格证明
(1)资格证明包括《医疗器械生产企业许可证》副本复印件及《工商营业执照》副本复印件。
(2)申请注册