Medical Devices Act Article 7
The term "labels", as used in this Act, shall refer to the words, graphics, or symbols displayed on a medical device or the packaging thereof.The term "instructions", as used in this Act, shall refer to the related materials that describe information on product safety, effectiveness, and use of medical devices.
中文原文 醫療器材管理法第7條
本法所稱標籤，指標示於醫療器材或其包裝上之文字、圖畫或記號。
本法所稱說明書，指對醫療器材安全、效能及使用等產品資訊之相關說明資料。
本法所稱說明書，指對醫療器材安全、效能及使用等產品資訊之相關說明資料。