Medical Devices Act Article 26
Alteration may only be made to any of the particulars of registration and market approval or listing pertaining to any medical device designated by the central competent authority after approval of the central competent authority is obtained.
中文原文 醫療器材管理法第26條
醫療器材查驗登記或登錄之事項,經中央主管機關指定者,其變更應報中央主管機關核准後,始得為之。