Medical Devices Act Article 36
If any of the following circumstances applies to the medical devices for which special approval for manufacture or import has been obtained as set forth in the preceding article, the central competent authority may cancel their approval and order the applicant to take action on or recall the said medical devices within a time period:1. An appropriate alternative treatment becomes available.2. The public health emergency situation is over.3. There is concern about the safety or therapeutic effect as evaluated and confirmed by the central competent authority.
中文原文 醫療器材管理法第36條
前條專案核准製造或輸入之醫療器材，有下列情形之一者，中央主管機關得廢止其核准及令申請者限期處理或回收該醫療器材：
一、已有合適替代療法。
二、緊急公共衛生情事已終結。
三、經中央主管機關評估確有安全或醫療效能之疑慮。
一、已有合適替代療法。
二、緊急公共衛生情事已終結。
三、經中央主管機關評估確有安全或醫療效能之疑慮。