Pharmaceutical Affairs Act Article 23
The term “defective medical devices” as used in this Act shall refer to the medical devices which fall within any of the following circumstances after inspection or testing:1. Which, when used, is liable to cause danger or harm to the human body or to mislead diagnosis;2. Which contains toxic or hazardous substances and so be, when used, detrimental to the health of human beings;3. Which has expired its duration of validity or expiration date; or4. of Which the quality, quantity, or potency is inconsistent with those previously approved.
中文原文 藥事法第23條
本法所稱不良醫療器材，係指醫療器材經稽查或檢驗有左列各款情形之一者：
一、使用時易生危險，或可損傷人體，或使診斷發生錯誤者。
二、含有毒質或有害物質，致使用時有損人體健康者。
三、超過有效期間或保存期限者。
四、性能或有效成分之質、量或強度，與核准不符者。
一、使用時易生危險，或可損傷人體，或使診斷發生錯誤者。
二、含有毒質或有害物質，致使用時有損人體健康者。
三、超過有效期間或保存期限者。
四、性能或有效成分之質、量或強度，與核准不符者。