Medical Devices Act Article 52
Medical device product items designated by the central competent authority shall only be released after passing random inspections or tests at the time of import.Regulations governing the product items and the items, modes, methods, scope, fees for random inspection and testing of medical devices referred to in the preceding paragraph, and other related matters shall be established by the central competent authority.
中文原文 醫療器材管理法第52條
經中央主管機關指定之醫療器材品項，其輸入時應經抽查、檢驗，合格後始得放行。
前項醫療器材之品項、抽查與檢驗項目、方式、方法、範圍、收費及其他相關事項之辦法，由中央主管機關定之。
前項醫療器材之品項、抽查與檢驗項目、方式、方法、範圍、收費及其他相關事項之辦法，由中央主管機關定之。