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医療機器の監視指導について - aiikou-k.org

2 .. 1.. 2. 1.. 3.. 4. 2.. 1002 8 26 10 2 .. 26 11 25 .. 26 11 25 . 29 11 25 . 5.. 6. 3.. 7.. 8. 4.. 9.. 10. 5.. 11.. 12. 6.. 68 9.. 13.. 68 11.. 80 2 . 228 22 14. 7.. 68 9.. 68 11.. 15. HP .. TOP .. WORD 16. 8.. 17.. 18. PMDA HP . 9.. X 16 . X 23 . X 26 . PMDA . 3 . Y 5 . 1 . Z 1 PMDA .. Z 5 . 19.. 68 11. X 16 .. X 23 .. X 26 . PMDA . 3 .. Y 5 .. 1 . Z 1 PMDA .. Z 5 . 20. 10.. 21.. 27 28 . 27 6 1 . 4 2 . 1 . 28 6 . 4 2 . 22. 11.. 27 28 .. 23.. 27 2 . 28 5 . 4 3 . 24.. 12.. 25.. HP.. PMDA . 26. attention/recall- 13.. 1002 8 26 10 2 .. 26 11 25 .. 26 11 25 . 29 11 25 . 27.. 052-954-6344. 28. 14.

3 はじめに 医療機器にも添付文書! ・第六十三条の二関連 参考通知 「医療機器の添付文書の記載要領の改正について」

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Transcription of 医療機器の監視指導について - aiikou-k.org

1 2 .. 1.. 2. 1.. 3.. 4. 2.. 1002 8 26 10 2 .. 26 11 25 .. 26 11 25 . 29 11 25 . 5.. 6. 3.. 7.. 8. 4.. 9.. 10. 5.. 11.. 12. 6.. 68 9.. 13.. 68 11.. 80 2 . 228 22 14. 7.. 68 9.. 68 11.. 15. HP .. TOP .. WORD 16. 8.. 17.. 18. PMDA HP . 9.. X 16 . X 23 . X 26 . PMDA . 3 . Y 5 . 1 . Z 1 PMDA .. Z 5 . 19.. 68 11. X 16 .. X 23 .. X 26 . PMDA . 3 .. Y 5 .. 1 . Z 1 PMDA .. Z 5 . 20. 10.. 21.. 27 28 . 27 6 1 . 4 2 . 1 . 28 6 . 4 2 . 22. 11.. 27 28 .. 23.. 27 2 . 28 5 . 4 3 . 24.. 12.. 25.. HP.. PMDA . 26. attention/recall- 13.. 1002 8 26 10 2 .. 26 11 25 .. 26 11 25 . 29 11 25 . 27.. 052-954-6344. 28. 14.


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