Regulation for Registration of Medical Devices Article 27
The following documents shall be attached when applying for changing the name of manufacturing factory 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 manufacturer covering letter that explains the change in manufacturing factory name.4.Photocopy of pharmaceutical firm permit license of the manufacturing factory with the new name.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.In the event the domestically manufactured medical device applying for the change and the changed manufacturing factory is a commissioned one, in addition to the previous two paragraphs, it shall be in conformity with the Regulations for Medicament Contract Manufacture and Analysis.
中文原文 醫療器材查驗登記審查準則第27條
申請變更醫療器材許可證之製造廠名稱，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、原廠廠名變更說明函正本。
四、新廠名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。
如變更之國產醫療器材製造廠係接受委託製造者，除應依前二項規定辦理外，並應符合藥物委託製造及檢驗作業準則之規定。
一、藥物變更登記申請書。
二、原許可證正本。
三、原廠廠名變更說明函正本。
四、新廠名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。
如變更之國產醫療器材製造廠係接受委託製造者，除應依前二項規定辦理外，並應符合藥物委託製造及檢驗作業準則之規定。