Regulation for Registration of Medical Devices Article 30
An application for transfer registration shall be made in accordance with regulations of Article 29 when a change in the name of the pharmaceutical firm holding a medical device permit license involves the transfer of rights.The following documents shall be attached when applying for a change in the name of the pharmaceutical firm holding a medical device permit license when the transfer of rights is not involved:1.Application form for change in medical device permit license.2.Original copy of the medical device permit license.3.Photocopy of pharmaceutical firm permit license after the name change.4.One affidavit from the pharmaceutical firm after name change affirming responsible for every item on the changed permit.5.One affidavit that claims no transfer of rights involved in this application for change in name of the pharmaceutical firm.
中文原文 醫療器材查驗登記審查準則第30條
醫療器材許可證之藥商名稱變更，如涉及權利移轉者，應依第二十九條規定，申請許可證移轉登記。
醫療器材許可證之藥商名稱變更，如未涉及許可證移轉者，應檢附下列資料，申請變更登記一、藥物變更登記申請書。
二、原許可證正本。
三、名稱變更後之藥商許可執照影本。
四、名稱變更後之藥商出具對變更許可證之各該藥物負責之切結書各一份。
五、藥商名稱變更未涉許可證移轉切結書。
醫療器材許可證之藥商名稱變更，如未涉及許可證移轉者，應檢附下列資料，申請變更登記一、藥物變更登記申請書。
二、原許可證正本。
三、名稱變更後之藥商許可執照影本。
四、名稱變更後之藥商出具對變更許可證之各該藥物負責之切結書各一份。
五、藥商名稱變更未涉許可證移轉切結書。