Regulation for Registration of Medical Devices Article 24
The following documents shall be attached when applying for change of the specifications on a medical device permit license: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 each 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, performance, 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 comparison and explanation of the changed specifications and the originally approved specifications issued by the original manufacturer;8.The original copy of the manufacture and free sale certificate of the country of origin.9.The original copy of foreign original manufacturer authorization letter.10.Two copies of radiation safety information for equipment generating ionizing radiation.The documents in The documents in Subparagraphs 8 and 9 of the foregoing Paragraph may be waived when applying to change a domestically-manufactured medical device permit license.The application for change of the specifications of a medical device shall be in conformity with the preceding two paragraphs if such a device is a Class III IVD. Moreover, if the IVD is required to undergo testing, as announced by the central health competent authority, two (2) copies of the documents specified in Subparagraph 5 of Paragraph 1 shall be submitted, and submission for testing shall be required.The medical device applying for registration in Paragraph 1 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24條
申請醫療器材許可證變更規格，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影本。
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。
但申請增加規格之醫療器材如係儀器類產品者，得以涵蓋本款資料之操作手冊及維修手冊替代之。
七、原廠出具之擬變更規格與原核准者差異比較及說明正本。
八、出產國許可製售證明正本。
九、國外原廠授權登記書正本。
十、發生游離輻射線器材之輻射線防護安全資料二份。
如係申請國產醫療器材許可證變更者，免附前項第八款及第九款資料。
申請變更規格之醫療器材如係第三等級體外診斷醫療器材者，除應依前二項規定辦理外，若屬中央衛生主管機關公告應辦理檢驗之體外診斷醫療器材者，其第一項第五款資料應檢附二份，並應送驗。
依第一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影本。
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。
但申請增加規格之醫療器材如係儀器類產品者，得以涵蓋本款資料之操作手冊及維修手冊替代之。
七、原廠出具之擬變更規格與原核准者差異比較及說明正本。
八、出產國許可製售證明正本。
九、國外原廠授權登記書正本。
十、發生游離輻射線器材之輻射線防護安全資料二份。
如係申請國產醫療器材許可證變更者，免附前項第八款及第九款資料。
申請變更規格之醫療器材如係第三等級體外診斷醫療器材者，除應依前二項規定辦理外，若屬中央衛生主管機關公告應辦理檢驗之體外診斷醫療器材者，其第一項第五款資料應檢附二份，並應送驗。
依第一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。