Regulation for Registration of Medical Devices Article 29
The following documents shall be attached when applying for transferring the right of the medical device permit license holder:1.Application form for change in medical device permit license.2.Original copy of the medical device permit license.3.Original copy of a permit letter of assignment from the pharmaceutical firm transferring agency rights (assignor).4.An affidavit from the pharmaceutical firm receiving agency rights (assignee) affirming responsible for the transferred medicament.5.Original copy of the foreign original manufacturer's authorization certificate; its content shall explain in detail about termination of the rights of the transferor, and bestowing of such rights to the transferee, and shall state the product name and the names and addresses of assignor and assignee, and the certificate shall be valid with one year from the date of issuance by the original manufacturer.6.Affidavit (A).7.Photocopy of pharmaceutical firm license of the assignee.Application for registration shall be applied by the transferor and the transferee jointly.
中文原文 醫療器材查驗登記審查準則第29條
申請醫療器材許可證移轉登記，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、讓與許可證之藥商（讓與人）所出具之讓渡書正本。
四、受讓許可證之藥商（受讓人）對受讓藥物負責之切結書。
五、國外原廠授權登記書正本，內容應詳述終止讓與人之登記權利，改由受讓人登記，並應詳列品名、讓與人及受讓人雙方名稱、地址；限原廠出具日起一年內有效。
六、切結書（甲）。
七、受讓人之藥商許可執照影本一份。
前項登記，應由讓與人及受讓人雙方共同申請。
一、藥物變更登記申請書。
二、原許可證正本。
三、讓與許可證之藥商（讓與人）所出具之讓渡書正本。
四、受讓許可證之藥商（受讓人）對受讓藥物負責之切結書。
五、國外原廠授權登記書正本，內容應詳述終止讓與人之登記權利，改由受讓人登記，並應詳列品名、讓與人及受讓人雙方名稱、地址；限原廠出具日起一年內有效。
六、切結書（甲）。
七、受讓人之藥商許可執照影本一份。
前項登記，應由讓與人及受讓人雙方共同申請。