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赣州二类医疗器械备案资质办理流程和材料

  • 2026-02-27 11:21:35
赣州二类医疗器械备案资质办理流程和材料
材料名称要求说明备注
《第二类医疗器械经营备案表》
使用A4纸打印，法定代表人签字
需在“器械经营企业电子申报端”填写生成
企业营业执照复印件
经营范围含二类医疗器械销售
需提交原件核对
法定代表人/负责人/质量负责人材料
身份证、学历证明、职称证明复印件
质量负责人需相关专业背景
经营与仓储场地证明
• 地理位置图、平面图（标注尺寸及面积）• 房屋产权证明或租赁协议（附产权方证明）
商用地址，仓库单独提供
组织机构设置说明
部门职能文件+组织结构图
附员工花名册
经营设施设备目录
列出仓储/办公设备清单
如温控设备、货架等
质量管理制度文件目录
包括采购、验收、售后服务等程序文件
需涵盖经营全流程
经办人授权委托书
需加盖公章
办理机构：赣州市审批局
赣州市章贡区、开发区、赣县区、南康区、于都县、瑞金市、会昌县、石城县、宁都县、信丰县、大余县等十八县区办理二类医疗器械备案都是在赣州市行政审批局办理哦，需要办理的话可以联系我们代办哦
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  1. CONNECT:[ UseTime:0.001030s ] mysql:host=127.0.0.1;port=3306;dbname=aa460;charset=utf8mb4
  2. SHOW FULL COLUMNS FROM `fenlei` [ RunTime:0.001794s ]
  3. SELECT * FROM `fenlei` WHERE `fid` = 0 [ RunTime:0.000648s ]
  4. SELECT * FROM `fenlei` WHERE `fid` = 63 [ RunTime:0.000587s ]
  5. SHOW FULL COLUMNS FROM `set` [ RunTime:0.001228s ]
  6. SELECT * FROM `set` [ RunTime:0.000512s ]
  7. SHOW FULL COLUMNS FROM `article` [ RunTime:0.001336s ]
  8. SELECT * FROM `article` WHERE `id` = 459751 LIMIT 1 [ RunTime:0.000800s ]
  9. UPDATE `article` SET `lasttime` = 1772203061 WHERE `id` = 459751 [ RunTime:0.009191s ]
  10. SELECT * FROM `fenlei` WHERE `id` = 65 LIMIT 1 [ RunTime:0.000569s ]
  11. SELECT * FROM `article` WHERE `id` < 459751 ORDER BY `id` DESC LIMIT 1 [ RunTime:0.000981s ]
  12. SELECT * FROM `article` WHERE `id` > 459751 ORDER BY `id` ASC LIMIT 1 [ RunTime:0.000940s ]
  13. SELECT * FROM `article` WHERE `id` < 459751 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.001891s ]
  14. SELECT * FROM `article` WHERE `id` < 459751 ORDER BY `id` DESC LIMIT 10,10 [ RunTime:0.001868s ]
  15. SELECT * FROM `article` WHERE `id` < 459751 ORDER BY `id` DESC LIMIT 20,10 [ RunTime:0.002572s ]
0.184677s