7.1 產品實現的策劃 |
| Article10-9,3rd paragraph(g)Annex IX 2.2,2nd paragraph(a)Annex XI 6.2,2nd paragraph,reference to Annex IX,2.2(a)
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| Article 10-9,3rd paragraph(e)Annex IX 2.2,2nd paragraph(c)indent 3 |
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| Article10-9,3rd paragraph(b)Annex IX 2.2,2nd paragraph(c)indent 2 |
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| 處理與主管當局、公告機構、其他經濟運營商、客戶和/或其他利益相關者的溝通; |
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| Annex IX 2.2,2nd paragraph(c)indent 5 |
| Article 10-9,3rd paragraph(g) |
| Article 10-9,1st paragraph,2nd sentence;Article10-9,3rd paragraph(b);Annex IX 2.2,2nd paragraph(c)indent 2-協調標準/CS要求;Annex IX 2.2,2nd paragraph(c)indent 6-Annex 1 第III章要求-隨附文件Annex IX 2.2,2nd paragraph(c)indent 8-變更控制 |
| Article10-9,3rd paragraph(b) GSPR |
| Article10-9,3rd paragraph(b)-GSRP Annex IX 2.2,2nd paragraph(b)indent 2-不合格品控制Annex XI 6.2,2nd paragraph,reference to Annex IX,2.2(b),indent2-不合格品控制 |
| Annex IX 2.2,2nd paragraph(c)indent 5滿足有關設計和構造的適用特定要求的解決方案,包括適當的臨床前評估,特別是附件 I 第 II 章的要求, |
| Annex I(1) |
| Article 10-9,3rd paragraph(g) |
| Article 10-9,1st paragraph,2nd sentenceArticle 10-9,3rd paragraph(a)Annex IX 2.2,2nd paragraph(c)indent 1Annex IX 2.2,2nd paragraph(c)indent 8 |
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| Article 9,3rd paragraph(d)Annex XI 6.2,2nd paragraph,reference to Annex IX,2.2(b),indent 3Annex IX 2.2,2nd paragraph(b)indent 3 |
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| Annex IX 2.2,2nd paragraph (e)Annex XI 6.2,2nd paragraph,reference to Annex IX,2.2(e) |
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| Article 10-9,3rd paragraph(g)Annex IX 2.2,2nd paragraph(c)indent 6Annex IX 2.2,2nd paragraph (d)Annex IX 2.2,2nd paragraph (e)Annex XI 6.2,2nd paragraph,reference to Annex IX,2.2(d) |
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| Annex IX 2.2,2nd paragraph (d) |
| Annex IX 2.2,2nd paragraph (d) Annex XI 6.2,2nd paragraph,reference to Annex IX,2.2(d) |
| Annex IX 2.2,2nd paragraph (d)Annex XI 6.2,2nd paragraph,reference to Annex IX,2.2(d) |
| Annex IX 2.2,2nd paragraph(c)indent 7 |
| Annex IX 2.2,2nd paragraph(c)indent 7Annex IX 2.2,2nd paragraph (e) |
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| Article 10-9,3rd paragraph(m)Annex IX 2.2,2nd paragraph (e)Annex XI 6.2,2nd paragraph,reference to Annex IX,2.2(b),indent 2Annex XI 6.2,2nd paragraph,reference to Annex IX,2.2(e)Annex IX 2.2,2nd paragraph(b)indent 2 |
| Article 10-9,3rd paragraph(m)Annex IX 2.2,2nd paragraph (e)Annex XI 6.2,2nd paragraph,reference to Annex IX,2.2(b),indent 2Annex XI 6.2,2nd paragraph,reference to Annex IX,2.2(e)Annex IX 2.2,2nd paragraph(b)indent 2 |
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| Annex XI 6.2,2nd paragraph,reference to Annex IX,2.2(b),indent 2Annex IX 2.2,2nd paragraph(b)indent 2 |
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| Article 10-9,3rd paragraph(k)
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