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夜雨聆风 > > 办公文件 > 新版自查表模板《医疗器械生产质量管理规范》

新版自查表模板《医疗器械生产质量管理规范》

当前时间： 2026-07-22 15:03:17 分类：办公文件 评论(0)
新版自查表模板《医疗器械生产质量管理规范》

↑请关注公众号【医械人学习圈】，欢迎转发

推荐新国标GB/T42061/ISO13485内审员

推荐新版医疗器械生产质量管理规范

如需电子版加微信(备注单位+姓名)
扫码或搜索：18511323658（徐娟）
来源：安徽省药品监督管理局

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往期精选

核查中心：新修订《医疗器械生产质量管理规范》PPT政策解读
关于温湿度，药监局回复了！以及各国药典中关于温度的规定

质量部工作任务清单，收藏打印！

无菌检查法对比（2025版药典 VS 2020版药典）

医疗器械生产企业《质量手册‌》

【汇总】菌种代号的意义、菌种传代与保存方法

2025版药典无菌直接接种法-模版

医疗器械生产质量管理规范检查指南第一册-216页

医疗器械生产质量管理规范检查指南第二册-431页

医疗器械技术常见500个问题与答案集锦-146页

如何制定一份好的作业指导书（WI/SOP）？

说明书和标签撰写规范与常见错误
2025年医疗器械生产企业飞行检查详细情况汇总
请查收！43个质量管理体系流程图
飞检惊魂72小时（一名管代的飞检日记）

官方最新解答：管理者代表可以由法定代表人或总经理兼任

官方回复：医疗器械注册证到期了，未如期延续或者注销，注册证有效期内生产的产品能销售吗？

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  1. CONNECT:[ UseTime:0.000567s ] mysql:host=127.0.0.1;port=3306;dbname=wenku;charset=utf8mb4
  2. SHOW FULL COLUMNS FROM `fenlei` [ RunTime:0.000835s ]
  3. SELECT * FROM `fenlei` WHERE `fid` = 0 [ RunTime:0.000313s ]
  4. SELECT * FROM `fenlei` WHERE `fid` = 63 [ RunTime:0.000253s ]
  5. SHOW FULL COLUMNS FROM `set` [ RunTime:0.000566s ]
  6. SELECT * FROM `set` [ RunTime:0.000214s ]
  7. SHOW FULL COLUMNS FROM `article` [ RunTime:0.000684s ]
  8. SELECT * FROM `article` WHERE `id` = 870713 LIMIT 1 [ RunTime:0.000502s ]
  9. UPDATE `article` SET `lasttime` = 1784706395 WHERE `id` = 870713 [ RunTime:0.013965s ]
  10. SELECT * FROM `fenlei` WHERE `id` = 64 LIMIT 1 [ RunTime:0.000418s ]
  11. SELECT * FROM `article` WHERE `id` < 870713 ORDER BY `id` DESC LIMIT 1 [ RunTime:0.000541s ]
  12. SELECT * FROM `article` WHERE `id` > 870713 ORDER BY `id` ASC LIMIT 1 [ RunTime:0.000492s ]
  13. SELECT * FROM `article` WHERE `id` < 870713 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.000701s ]
  14. SELECT * FROM `article` WHERE `id` < 870713 ORDER BY `id` DESC LIMIT 10,10 [ RunTime:0.000702s ]
  15. SELECT * FROM `article` WHERE `id` < 870713 ORDER BY `id` DESC LIMIT 20,10 [ RunTime:0.000690s ]
0.099007s