Medical Devices Act Article 32
Medical device firms that manufacture or import medical devices shall attach labels in Chinese to the smallest packaging unit for sale and provide Chinese instructions before engaging in the sale, wholesale, and retail. However, this shall not apply to those announced or approved by the central competent authority due to the difficulty in compliance.
中文原文 醫療器材管理法第32條
醫療器材商製造、輸入醫療器材，應於最小販售包裝標示中文標籤，並附中文說明書，始得買賣、批發及零售。
但因窒礙難行，經中央主管機關公告或核准者，不在此限。
但因窒礙難行，經中央主管機關公告或核准者，不在此限。