Regulation for Registration of Medical Devices Article 22
For application of change of English product name, 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 manufacturer covering letter that explains the change in product name.4.The original copy of the manufacture and free sale certificate of the country of origin; its content shall indicate the product applying for change in product name and the already approved product are in fact the same.5.Relevant documents shall be attached if a trademark is being registered.In the event of applying for change in product name for a domestically manufactured medical device, Subparagraph 4 of the preceding paragraph shall be exempted.
中文原文 醫療器材查驗登記審查準則第22條
申請變更醫療器材許可證之英文品名，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、原廠品名變更說明函正本。
四、出產國許可製售證明正本，其內容應可辨識變更後之產品與原核准相同。
五、如商標經註冊者，應檢附相關資料。
如係申請國產醫療器材許可證變更者，免附前項第四款資料。
一、藥物變更登記申請書。
二、原許可證正本。
三、原廠品名變更說明函正本。
四、出產國許可製售證明正本，其內容應可辨識變更後之產品與原核准相同。
五、如商標經註冊者，應檢附相關資料。
如係申請國產醫療器材許可證變更者，免附前項第四款資料。