Regulation for Registration of Medical Devices Article 26
The following documents shall be attached when applying for change in medical device efficacy, indication, performance, instruction for use, or dosage on a medical device permit, the following documents shall be submitted:1.Application form for change in medical device permit license.2.Original copy of the medical device permit license.3.Original copy of the already approved instruction leaflet stamped with tally impression of the central health competent authority.4.Two copies of each of the following items: the affixed or stapled to the label attachment form of instructions and manual with detailed Chinese translations, packaging, labels and color pictures of the physical appearance of product.5.One copy of the following items: pre-clinical testing and the test specifications and methods, the original test records, and the test reports of the quality control conducted by the original manufacturer.6.One copy of each of the relevant documents concerning product structure, materials, specifications, functions, intended uses, and drawings, etc. For instrument product, an operation manual or a service manual covers all of the abovementioned items may be a substitution.7.The original copy of the manufacture and free sale certificate of the country of origin.8.The original copy of foreign original manufacturer authorization letter.9.Theoretical basis and relevant research reports and data.10.Clinical trial reports.11. The original copy of the comparison and explanation of the changed particulars and the originally approved particulars issued by the original manufacturer.In the event of applying for change of a domestically manufactured medical device, Subparagraph 7 and 8 and of the preceding paragraph shall be exempted.In the event of already a product in the market similar to the medical device applying for changes of Paragraph 1, the documents specified in Subparagraphs 9 and 10 of Paragraph 1 may be waived.The medical device applying for registration in Paragraph 1 and Paragraph 3 shall be in conformity with related rules or regulations announced by the central health competent authority, and the documents exempted from submission shall be kept in the manufacturing factory. The central health competent authority may order its submission when necessary.
中文原文 醫療器材查驗登記審查準則第26條
申請醫療器材許可證變更效能、適應症、性能、用法或用量等事項者，應檢附下列資料：
一、藥物變更登記申請書。
二、原許可證正本。
三、原核准並蓋有中央衛生主管機關騎縫章之仿單標籤核定本正本。
四、黏貼或裝釘於標籤黏貼表上之仿單目錄、使用說明書及其詳細中文譯稿、包裝、標籤及產品實際外觀彩色圖片各二份。
五、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一份。
六、產品之結構、材料、規格、性能、用途、圖樣等有關資料一份。
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。
七、出產國許可製售證明正本。
八、國外原廠授權登記書正本。
九、學術理論依據與有關研究報告及資料。
十、臨床試驗報告。
十一、原廠出具之擬變更事項與原核准者差異比較及說明正本。
申請國產醫療器材許可證變更者，免附前項第七款及第八款資料。
申請第一項變更者，已有類似品經中央衛生主管機關核准上市者，得免附第一項第九款及第十款資料。
依第一項及第三項規定辦理變更登記之醫療器材，應符合中央衛生主管機關公告之相關規定，得免附之資料應留廠備查，必要時，中央衛生主管機關得命提出相關資料。
一、藥物變更登記申請書。
二、原許可證正本。
三、原核准並蓋有中央衛生主管機關騎縫章之仿單標籤核定本正本。
四、黏貼或裝釘於標籤黏貼表上之仿單目錄、使用說明書及其詳細中文譯稿、包裝、標籤及產品實際外觀彩色圖片各二份。
五、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一份。
六、產品之結構、材料、規格、性能、用途、圖樣等有關資料一份。
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。
七、出產國許可製售證明正本。
八、國外原廠授權登記書正本。
九、學術理論依據與有關研究報告及資料。
十、臨床試驗報告。
十一、原廠出具之擬變更事項與原核准者差異比較及說明正本。
申請國產醫療器材許可證變更者，免附前項第七款及第八款資料。
申請第一項變更者，已有類似品經中央衛生主管機關核准上市者，得免附第一項第九款及第十款資料。
依第一項及第三項規定辦理變更登記之醫療器材，應符合中央衛生主管機關公告之相關規定，得免附之資料應留廠備查，必要時，中央衛生主管機關得命提出相關資料。