Medical Devices Act Article 55
Regarding medical devices suspected to have not been registered and approved or listed or to be defective medical devices, for medical devices that have not been registered and approved or listed, the municipal or county (city) competent authority shall first place them in confinement at the site and take samples for inspection or testing before taking further actions. For defective medical devices, the authority may first place them in confinement at the site and take samples for inspection or testing before taking further actions. As for those which have caused serious harm, they shall be confiscated and destroyed after reporting for approval to the central competent authority.The quantity of the samples set forth in the preceding paragraph shall be limited to the extent sufficient for use in inspection or testing, and receipts shall be given to business operators.For medical devices set forth in Paragraph 1, the competent authority may notify or announce the withdrawal, cessation of use, or suspension of the manufacture, import, or sale thereof.
中文原文 醫療器材管理法第55條
直轄市、縣（市）主管機關對疑為未經查驗登記、登錄之醫療器材或不良醫療器材，就未經查驗登記、登錄之醫療器材部分，應先行就地封存，並抽取樣品予以查核或檢驗後，再行處理；就不良醫療器材部分，得先行就地封存，並抽取樣品予以查核或檢驗後，再行處理。
其已發生重大危害者，應於報請中央主管機關核准後，沒入銷燬之。
前項抽驗數量，以足供查核或檢驗之用者為限，並應交付憑據予業者。
第一項醫療器材，主管機關得通知或公告其下架、停止使用，或暫停製造、輸入、販賣。
其已發生重大危害者，應於報請中央主管機關核准後，沒入銷燬之。
前項抽驗數量，以足供查核或檢驗之用者為限，並應交付憑據予業者。
第一項醫療器材，主管機關得通知或公告其下架、停止使用，或暫停製造、輸入、販賣。