Medical Devices Act Article 35
The central competent authority may grant special approval for manufacture or import of specific medical devices without the limitations set forth in Paragraph 1 of Article 25 if any of the following circumstances applies:1. For the purpose of preventing, diagnosing, or treating life-threatening or severe disability diseases, with appropriate alternative treatment not yet available domestically.2. The necessity of responding to emergency public health circumstances.3. Investigational medical devices.4. For the exclusive use as samples or gifts, or for personal use.5. Where the import thereof is for the exclusive purpose of repair, and not for circulation or sale domestically after the repair is completed.6. Where circumstances exist for incapable to continue with the manufacture, import, or for insufficient supply of licensed products that have been announced as necessary medical devices in accordance with Paragraph 4 of the preceding paragraph.Regulations governing the application requirements, review procedures, approval criteria, restrictions on supply and sale, return, and other matters to be complied with in regard to the special approval referred to in the preceding paragraph shall be established by the central competent authority.
中文原文 醫療器材管理法第35條
有下列情形之一者，中央主管機關得專案核准特定醫療器材之製造或輸入，不受第二十五條第一項規定之限制：
一、為預防、診治危及生命或嚴重失能之疾病，國內尚無合適替代療法。
二、因應緊急公共衛生情事之需要。
三、試驗用醫療器材。
四、專供樣品或贈品之用，或個人自用。
五、輸入專供維修，且修復後非於國內流通販賣。
六、依前條第四項公告為必要醫療器材之許可證產品，有無法繼續製造、輸入或不足供應之情形。
前項專案核准之申請條件、審查程序、核准基準、供售限制、退運及其他應遵行事項之辦法，由中央主管機關定之。
一、為預防、診治危及生命或嚴重失能之疾病，國內尚無合適替代療法。
二、因應緊急公共衛生情事之需要。
三、試驗用醫療器材。
四、專供樣品或贈品之用，或個人自用。
五、輸入專供維修，且修復後非於國內流通販賣。
六、依前條第四項公告為必要醫療器材之許可證產品，有無法繼續製造、輸入或不足供應之情形。
前項專案核准之申請條件、審查程序、核准基準、供售限制、退運及其他應遵行事項之辦法，由中央主管機關定之。