Regulation for Registration of Medical Devices Article 8
A foreign original manufacturer authorization letter (hereafter referred to as authorization letter) mentioned in this Regulation means an authorized agent letter issued by a foreign original manufacturer of the imported medical devices, provided the following requirements are met:1.The content of an authorization letter shall explicitly state that the original manufacturer authorizes the importer in Taiwan to apply for registration and market approval, and shall specify the commissioned or authorized company's name and address, and the name, specifications, and model of the medical device. 2.The authorization letter shall be valid within one year from its issuance date. If the authorization letter is not written in English, either a Chinese or an English version of translation of the authorization letter shall be submitted as well.The authorization letter in the preceding paragraph may be substituted by the following document:1.An authorization letter issued by the headquarter of the imported medical devices, that clearly indicates that the headquarter authorizes the importer to register, shall explicitly state the name and address of the manufacturing factory, and shall specify the commissioned or authorized company's name and address, and the name, specifications, and model of the medical device.2.An authorization letter issued by the original manufacturer of the imported medical device to its foreign agent, and another authorization letter issued by the foreign agent that authorizes the importer to register, that shall explicitly state the name and address of the manufacturing factory, and shall specify the commissioned or authorized company's name and address, and the name, specifications, and model of the medical device.The substitution in the preceding paragraph shall be valid within one year from its issuance date. If the substitution is not written in English, either a Chinese or an English version of translation of the substitution shall be submitted as well.
中文原文 醫療器材查驗登記審查準則第8條
本準則所稱國外原廠授權登記書，係指由輸入醫療器材原製造廠出具之授權代理證明文件，並符合下列規定者：
一、內容須載明原製造廠授權我國代理商申請查驗登記（authorizedtoregister），並指明其委託或授權登記之藥商名稱、地址與醫療器材之名稱、規格型號等。
二、國外原廠授權登記書，限出具日起一年內有效；如非以英文出具者，並應同時檢附中文或英文譯本。
前項國外原廠授權登記書，得以下列文件替代之：
一、輸入醫療器材總公司出具之授權代理證明文件，授權我國代理商申請查驗登記（authorizedtoregister），其內容載明製造廠名稱、地址，並指明其委託或授權登記之藥商名稱、地址與醫療器材之名稱、規格型號等。
二、由輸入醫療器材原製造廠出具說明其國外代理商之證明文件，再由國外代理商出具之授權代理證明文件，授權我國代理商申請查驗登記（authorizedtoregister），並指明其委託或授權登記之藥商名稱、地址與醫療器材之名稱、規格型號等。
前項替代文件，限出具日起一年內有效；如非以英文出具者，並應同時檢附中文或英文譯本。
一、內容須載明原製造廠授權我國代理商申請查驗登記（authorizedtoregister），並指明其委託或授權登記之藥商名稱、地址與醫療器材之名稱、規格型號等。
二、國外原廠授權登記書，限出具日起一年內有效；如非以英文出具者，並應同時檢附中文或英文譯本。
前項國外原廠授權登記書，得以下列文件替代之：
一、輸入醫療器材總公司出具之授權代理證明文件，授權我國代理商申請查驗登記（authorizedtoregister），其內容載明製造廠名稱、地址，並指明其委託或授權登記之藥商名稱、地址與醫療器材之名稱、規格型號等。
二、由輸入醫療器材原製造廠出具說明其國外代理商之證明文件，再由國外代理商出具之授權代理證明文件，授權我國代理商申請查驗登記（authorizedtoregister），並指明其委託或授權登記之藥商名稱、地址與醫療器材之名稱、規格型號等。
前項替代文件，限出具日起一年內有效；如非以英文出具者，並應同時檢附中文或英文譯本。