Regulation for Registration of Medical Devices Article 18
In the event of applying for registration and market approval of the same domestically-manufactured 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 form for attaching outer box instruction label with all Chinese instruction leaflet catalog packaging, and labeling, instructions for use, and color pictures of the physical appearance of product.3.Affidavit (A)4.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.5.Photocopy of the already approved instruction leaflet and labels stamped with tally impression of the central health competent authority.6.Photocopy of the originally-approved medical device permit license.7.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.In the event of the pharmaceutical firm applying for registration and market approval different from the manufacturer, it shall be deemed as commission manufacturing. The medical device applying for registration and market approval 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18條
申請國產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中文仿單目錄、使用說明書、包裝、標籤及產品實際外觀彩色圖片各二份。
三、切結書（甲）。
四、原廠說明函，說明新申請產品與原核准之產品屬相同產品，並註明原核准之醫療器材許可證字號。
五、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。
六、原核准之醫療器材許可證影本。
七、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。
申請查驗登記之藥商與製造廠不同時，視為委託製造關係。
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中文仿單目錄、使用說明書、包裝、標籤及產品實際外觀彩色圖片各二份。
三、切結書（甲）。
四、原廠說明函，說明新申請產品與原核准之產品屬相同產品，並註明原核准之醫療器材許可證字號。
五、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。
六、原核准之醫療器材許可證影本。
七、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。
申請查驗登記之藥商與製造廠不同時，視為委託製造關係。
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。