Regulation for Registration of Medical Devices Article 28
The following documents shall be attached when applying for change in address of manufacturing factory (including the country of origin):1.Application form for change in medical device permit license.2.Original copy of the medical device permit license.3.Original manufacturer covering letter that explains the change in manufacturing factory address.4.Photocopy of pharmaceutical firm permit license of the manufacturing factory with the new address.5.Original copy of the manufacture and free sale certificate of the country of origin.6.The original copy of foreign original manufacturer authorization letter.7.Documents verifying that the manufacturing factory in conformity with the GMP for Medical Devices.In the event of applying for change in manufacturing factory name for an imported medical device, Subparagraph 4 of the preceding paragraph shall be exempted.In the event of applying for change in manufacturing factory name for a domestically manufactured medical device, Subparagraph 5 and 6 of Paragraph 1 shall be exempted.If change of the manufacturing factory address was due to house-numbering system change, document for Subparagraph 5 of Paragraph 1 may be exempted, a certificate issued by government shall be submitted; in the case of imported medical devices, the certificate shall be notarized by R.O.C (Taiwan) foreign affairs office.In the case of a Class III IVD, the application for change shall be in conformity with the preceding four paragraphs. Moreover, two (2) copies of the documents stating the test specifications and methods for pre-clinical testing and quality control conducted by the original manufacturer, the original test records, and the test result reports shall be submitted. If the IVD is required to undergo testing, as announced by the central health competent authority, submission for testing shall also be required.For medical devices for which an application for change of the address of the manufacturing factory is submitted in accordance with Paragraph 1, the central health competent authority may, if necessary, order submission of technical documentation such as relevant documents concerning product structure, materials, specifications, performance, intended use, drawing and others, and documents of pre-clinical testing, and the test results of quality control of the original manufacturer.
中文原文 醫療器材查驗登記審查準則第28條
申請變更醫療器材許可證之製造廠廠址（含製造國別之變更），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、原廠廠址變更說明函正本。
四、新廠址之製造業藥商許可執照影本。
五、出產國許可製售證明正本。
六、國外原廠授權登記書正本。
七、該製造廠符合醫療器材優良製造規範之證明文件影本。
如係申請輸入醫療器材許可證變更者，免附前項第四款資料。
如係申請國產醫療器材許可證變更者，免附第一項第五款及第六款資料。
製造廠地址變更如係因門牌整編者，得免附第一項第五款資料，但應檢附政府機關出具之證明文件，其屬輸入醫療器材者，並應經我國駐外館處驗證。
申請變更如係第三等級體外診斷醫療器材者，除應依前四項規定辦理外，並應檢附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；其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，並應送驗。
依第一項規定辦理製造廠廠址變更之醫療器材，必要時，中央衛生主管機關得命提出產品之結構、材料、規格、性能、用途、圖樣等相關資料、臨床前測試及原廠品質管制之檢驗資料等技術性文件。
一、藥物變更登記申請書。
二、原許可證正本。
三、原廠廠址變更說明函正本。
四、新廠址之製造業藥商許可執照影本。
五、出產國許可製售證明正本。
六、國外原廠授權登記書正本。
七、該製造廠符合醫療器材優良製造規範之證明文件影本。
如係申請輸入醫療器材許可證變更者，免附前項第四款資料。
如係申請國產醫療器材許可證變更者，免附第一項第五款及第六款資料。
製造廠地址變更如係因門牌整編者，得免附第一項第五款資料，但應檢附政府機關出具之證明文件，其屬輸入醫療器材者，並應經我國駐外館處驗證。
申請變更如係第三等級體外診斷醫療器材者，除應依前四項規定辦理外，並應檢附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；其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，並應送驗。
依第一項規定辦理製造廠廠址變更之醫療器材，必要時，中央衛生主管機關得命提出產品之結構、材料、規格、性能、用途、圖樣等相關資料、臨床前測試及原廠品質管制之檢驗資料等技術性文件。