應檢附資料
Attached information |
國產第二等級
Class II
(Domestic) |
輸入第二等級
Class II
(Overseas) |
國產第三等級
Class III
(Domestic) |
輸入第三等級
Class III
(overseas) |
醫療器材查驗登記申請書正、副本各一份
Medical device registration application letter (original and copy) |
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黏貼或裝釘於標籤黏貼表上之中文仿單目錄、使用說明書、包裝及標籤各三份
Chinese version of instruction directory, IFU, packaging and labeling to be affixed onto the labeling form (3copies each) |
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黏貼或裝釘於證照黏貼表上之醫療器材製造業藥商許可執照影本
Copy of the pharmaceutical manufacturing permit affixed onto the license form |
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切結書 (甲)
Declaration letter (A) |
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出產國許可製售證明正本
Original copy of the CFG |
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國外原廠授權登記書正本
Original copy of the letter of appointment from the original manufacturer |
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臨床前測試及原廠品質管制之檢驗規格與方法、原始檢驗紀錄及檢驗成績書二份
Evaluation specification and method, raw data and test results of the pre-clinical testing and quality control record of the original manufacturer (2 copies) |
註3
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註3
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產品之結構、材料、規格、性能、用途、圖樣等有關資料二份。但儀器類之產品，得以涵蓋本款資料之操作手冊及維修手冊替代之
Product architecture, material, specification, performance, intended use, diagrams and relevant information (2 copies). In the case of instrument type device, operation manual and repair/maintenance manual can be submitted instead |
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國內製造廠符合醫療器材優良製造規範之證明文件
GMP compliance documentation for domestic manufacturer |
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學術理論依據與有關研究報告及資料
Academic research report and information about the working principle and theory |
註1
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註1
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註1
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註1
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臨床試驗報告
Clinical trial report |
註1
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註1
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註1
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註1
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發生游離輻射線器材之輻射線防護安全資料二份
Radiation protection safety information for ionization emitting device (2 copies) |
註2
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註2
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註2
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註2
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