Regulation for Registration of Medical Devices Article 23
The following documents shall be attached when applying for change of the original manufacturer's instructions, label, or packaging on a medical device permit license:1.Application form for change in medical device permit license.2.A comparison table of the change and the original content.3.Original copy of the medical device permit license.4.Original copy of the already approved instruction leaflet stamped with tally impression of the central health competent authority.5.Original copy of a letter of explanation from the original manufacturer concerning the changes to instructions, label, or packaging.Two copies of each of the following item: the affixed or stapled to the label attachment form of the new version of instructions and manual with detailed Chinese translations, packaging, labels and color pictures of the physical appearance of product.
中文原文 醫療器材查驗登記審查準則第23條
申請變更醫療器材許可證之原廠仿單、標籤、包裝，應檢附下列資料：
一、藥物變更登記申請書。
二、擬變更之內容與原核准者之比較表。
三、原許可證正本。
四、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。
五、原廠出具之仿單、標籤、包裝變更說明函正本。
六、黏貼或裝釘於標籤黏貼表上之新仿單目錄、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。
一、藥物變更登記申請書。
二、擬變更之內容與原核准者之比較表。
三、原許可證正本。
四、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。
五、原廠出具之仿單、標籤、包裝變更說明函正本。
六、黏貼或裝釘於標籤黏貼表上之新仿單目錄、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。