Medical Devices Act Article 8
The term "defective medical devices", as used in this Act, shall refer to medical devices which fall within any of the following circumstances after inspection or testing:1. The occurrence of misdiagnosis is prompted or toxic or hazardous substances are contained, resulting in harm to the health of human body.2. The normal and reasonable use in accordance with directions indicated on the labels or instructions is liable to cause danger or harm to the health of human body.3. The duration of validity or storage life has expired.4. The performance or specification is inconsistent with the content that has been approved in registration, listed, or announced as set forth in Paragraph 2 of Article 30.5. The preservation is not in accordance with the storage conditions approved in registration.6. Foreign objects that affect product quality are mixed or packed.7. Other defects announced by the central competent authority.
中文原文 醫療器材管理法第8條
本法所稱不良醫療器材，指醫療器材經稽查或檢驗有下列情形之一者：
一、使診斷發生錯誤，或含有毒、有害物質，致危害人體健康。
二、依標籤或說明書刊載之用法，作正常合理使用時易生危險，或危害人體健康之虞。
三、超過有效期間或保存期限。
四、性能或規格與查驗登記、登錄之內容不符，或與第三十條第二項之公告內容不符。
五、未依查驗登記核准儲存條件保存。
六、混入或附著影響品質之異物。
七、經中央主管機關公告之其他瑕疵。
一、使診斷發生錯誤，或含有毒、有害物質，致危害人體健康。
二、依標籤或說明書刊載之用法，作正常合理使用時易生危險，或危害人體健康之虞。
三、超過有效期間或保存期限。
四、性能或規格與查驗登記、登錄之內容不符，或與第三十條第二項之公告內容不符。
五、未依查驗登記核准儲存條件保存。
六、混入或附著影響品質之異物。
七、經中央主管機關公告之其他瑕疵。