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宣贯PPT《新版医疗器械生产质量管理规范》

  • 2026-05-16 20:38:18
宣贯PPT《新版医疗器械生产质量管理规范》

课程推荐：

医疗器械质量管理体系ISO13485:2016(GB/T42061-2022)内审员培训

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《医疗器械生产质量管理规范》重点内容解读

大家好，我是国家药品监督管理局医疗器械监督管理司监管一处的李一捷。

下面由我来对新修订的《医疗器械生产质量管理规范》的重点内容进行解读。首先，刚才王昕司长已经介绍了新规范的大体架构变化。我再带大家回顾一下新修订的《医疗器械生产质量管理质量管理规范》（2025年第107号公告），它包含15个章节，共132个条款。。。。

声明：本文为转载/整理，仅供分享之用

推荐阅读

◆医疗器械生产质量管理规范（2025年第107号）

◆官方发布：《医疗器械生产质量管理规范》修订前后对照表

◆医疗器械生产质量管理规范对比（2014版 VS 2026版）

◆国家药监局综合司关于印发医疗器械注册自检核查指南的通知

◆企业负责人、管代、质量负责人必看！主体责任请查收！

◆无菌检查法对比（2025版药典 VS 2020版药典）

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  1. CONNECT:[ UseTime:0.001028s ] mysql:host=127.0.0.1;port=3306;dbname=h_sjds;charset=utf8mb4
  2. SHOW FULL COLUMNS FROM `fenlei` [ RunTime:0.001395s ]
  3. SELECT * FROM `fenlei` WHERE `fid` = 0 [ RunTime:0.000587s ]
  4. SELECT * FROM `fenlei` WHERE `fid` = 63 [ RunTime:0.000558s ]
  5. SHOW FULL COLUMNS FROM `set` [ RunTime:0.001148s ]
  6. SELECT * FROM `set` [ RunTime:0.000454s ]
  7. SHOW FULL COLUMNS FROM `article` [ RunTime:0.001227s ]
  8. SELECT * FROM `article` WHERE `id` = 507234 LIMIT 1 [ RunTime:0.000790s ]
  9. UPDATE `article` SET `lasttime` = 1779245319 WHERE `id` = 507234 [ RunTime:0.001815s ]
  10. SELECT * FROM `fenlei` WHERE `id` = 64 LIMIT 1 [ RunTime:0.000647s ]
  11. SELECT * FROM `article` WHERE `id` < 507234 ORDER BY `id` DESC LIMIT 1 [ RunTime:0.001081s ]
  12. SELECT * FROM `article` WHERE `id` > 507234 ORDER BY `id` ASC LIMIT 1 [ RunTime:0.000947s ]
  13. SELECT * FROM `article` WHERE `id` < 507234 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.002117s ]
  14. SELECT * FROM `article` WHERE `id` < 507234 ORDER BY `id` DESC LIMIT 10,10 [ RunTime:0.001660s ]
  15. SELECT * FROM `article` WHERE `id` < 507234 ORDER BY `id` DESC LIMIT 20,10 [ RunTime:0.002849s ]
0.174394s