Regulation for Registration of Medical Devices Article 19
In the event of applying for registration and market approval of the same imported product under a different name, the original medical device permit license holder or a pharmaceutical firms authorized by the original medical device permit license holder shall apply and submit the following documents:1.One copy of each of the original and photocopy of the medical device registration and market approval application form.2.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. 3.Affidavit (A)4.Original copy of the manufacture and free sale certificate of the country of origin, which shall explicitly state that the product for which a new application has been made and the originally-approved product are identical.5.The original copy of foreign original manufacturer authorization letter.6.An explanatory letter from the original manufacturer explaining that the product for which a new application has been made and the originally-approved product are identical, and noting the license number of the originally-approved medical device permit license.7.Photocopy of the already approved instruction leaflet and labels stamped with tally impression of the central health competent authority.8.Photocopy of the originally-approved medical device permit license.9.If the product name also bears the name or trademark of another manufacturer, the applicant shall attach a letter of consent from the company which its name or trademark has been added.If the medical device applying for registration is commissioned to manufacture or analysis, 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19條
申請輸入醫療器材同一產品不同品名之查驗登記，應由原許可證持有藥商或經原許可證持有藥商同意授權之藥商檢附下列資料申請之：
一、醫療器材查驗登記申請書正、副本各一份。
二、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。
三、切結書（甲）。
四、出產國許可製售證明正本，其內容並應載明新申請之產品名與原核准之產品係相同產品。
五、國外原廠授權登記書正本。
六、原廠說明函，說明新申請產品與原核准之產品係相同產品，並註明原核准之醫療器材許可證字號。
七、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。
八、原核准之醫療器材許可證影本。
九、如品名冠有其他廠商之名稱或商標者，應附被加冠者出具之同意函。
申請查驗登記之醫療器材如係委託製造或檢驗者，應符合藥物委託製造及檢驗作業準則之規定。
一、醫療器材查驗登記申請書正、副本各一份。
二、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。
三、切結書（甲）。
四、出產國許可製售證明正本，其內容並應載明新申請之產品名與原核准之產品係相同產品。
五、國外原廠授權登記書正本。
六、原廠說明函，說明新申請產品與原核准之產品係相同產品，並註明原核准之醫療器材許可證字號。
七、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。
八、原核准之醫療器材許可證影本。
九、如品名冠有其他廠商之名稱或商標者，應附被加冠者出具之同意函。
申請查驗登記之醫療器材如係委託製造或檢驗者，應符合藥物委託製造及檢驗作業準則之規定。