Contents of Technical File
Contents | Notes | |
Part A | ||
1 | Name, Postal Address of Manufacturer /EU Representive | |
2 | A listing of all manufacturing sites covered by the quality system | |
3 | Product description | |
3.1 | Product name, classification of the device and accessories | |
3.2 | List of accessories (if applicable) | |
3.3 | Specification, model and article numbers | |
3.4 | Chosen conformity assessment path | |
3.5 | Intended use | |
3.6 | Integral parts of the sales unit | |
3.7 | A brief product history (including existing regulatory approvals) | |
4 | List of harmonized standards | Satisfy the Annex I |
5 | Essential Requirements checklist | the solutions adopted to satisfy the Essential Requirements (template, English version) |
6 | Overall manufacturing and inspection plan of the product | |
7 | Risk analysis | EN ISO 14971:2007 (template, English version) |
8 | Clinical report | Detailed see in Part B |
9 | Labelling, inl. Product labels and package labels | (English version) |
10 | Instruction for use, patient information, advertising material | (English version) |
11 | Declaration of conformity | (template, English version) |
Part B | ||
12 | Information concerning the quality system specific to the product | |
13 | Detailed descriptions of the product | |
13.1 | Design drawings and product specifications | |
13.2 | Packaging and specification | (English version) |
13.3 | Description of the manufacturing processes | Drawings, qualification, Labeling control, Traceability,Product and environmental bioburden particles, Pyrogene testing, Preventive monitoring of processes (i.e. SPC), Viral- Prion Desactivation steps etc. |
13.4 | Raw materials and suppliers | |
14 | Test, verification and evaluation report | |
14.1 | Sterile method and validation | IQ/OQ/PQ |
14.2 | Packaging verification (if applicable) | Incl. package expired date |
14.3 | Chemical, physical and biology test, verification and evaluation report | |
15 | Clinical datas | The critical report must be in Part A of the Technical File. The publications quoted in the report must be available in Part B of the Technical File as original documents, reprints or copies. |
15.1 | Preclinical Evaluation, Expert Opinions | |
15.2 | Clinical plan | |
15.3 | Clinical datas | |
15.4 | Clinical Summary, Expert Opinions | |
15.5 | Clinical report | |
15.6 | Relevant Literature | |
技 術 文 檔 的 內 容
內 容 | 備 注 | |
Part A | ||
1 | 制造商和 歐洲代表的名字、地址 | |
2 | 質量體系所涉及的全部制造場所清單 | |
3 | 產品描述 | |
3.1 | 產品名字、器械及附件的分類 | |
3.2 | 產品附件清單（適用時） | |
3.3 | 規格、型號及貨號 | |
3.4 | 符合性評價路徑 | |
3.5 | 預期用途描述 | |
3.6 | 主要的銷售單元（適用時） | |
3.7 | 簡要的產品歷史（包括現有的管理審批） | |
4 | 適用的標準清單 | 符合醫療器械指令附錄I |
5 | 基本要求檢查表 | 符合醫療器械指令附錄I的方案 (有固定模板，需提交英文文件) |
6 | 產品的總體生產或質量控制方案 | |
7 | 風險分析 | EN ISO 14971:2007 有固定模板，需提交英文文件 |
8 | 臨床報告 | 詳細的臨床數據見Part B |
9 | 標簽，包括產品標簽、包裝標簽 | (需提交英文文件) |
10 | 使用說明、患者信息、廣告材料 | (需提交英文文件) |
11 | 符合性聲明 | (有固定模板，需提交英文文件) |
Part B | ||
12 | 與產品有關的質量體系的信息 | |
13 | 詳細的產品描述 | |
13.1 | 設計圖及產品技術規范 | |
13.2 | 包裝條件及規格 | (需提交英文文件) |
13.3 | 生產過程描述 | 包括流程圖、資格確認、標簽控制、追溯性、產品及生產環境控制、過程的預防監控、消毒或防護過程等 |
13.4 | 原材料和供方 | |
14 | 試驗、驗證及評估報告 | |
14.1 | 滅菌方法和驗證的概述，滅菌證書（適用時） | IQ/OQ/PQ |
14.2 | 包裝驗證（適用時） | 包括包裝有效期驗證 |
14.3 | 化學、物理和生物學試驗、驗證或評估報告 | |
15 | 臨床數據 | 臨床評價報告必須包含在技術文檔的第一部分中，報告中引用的出版物必須以原始文件、重印本或復印件的形成在即數文檔的第二部分提供 |
15.1 | 臨床前評估，專家意見 | |
15.2 | 臨床方案 | |
15.3 | 臨床數據 | |
15.4 | 臨床總結，專家意見 | |
15.5 | 臨床報告 | |
15.6 | 相關文獻 | |
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