Pharmaceutical Affairs Act Article 18
The term “medical device manufacturers,” as used in this Act, shall refer to the business undertakings that are engaged in manufacturing and assembling medical devices, wholesaling and exporting their own products, and importing raw materials for their own use.Medical device manufacturers, as specified in the preceding paragraph, may concurrently engage in the retailing of their own manufactured products.
中文原文 藥事法第18條
本法所稱醫療器材製造業者，係指製造、裝配醫療器材，與其產品之批發、輸出及自用原料輸入之業者。
前項醫療器材製造業者，得兼營自製產品之零售業務。
前項醫療器材製造業者，得兼營自製產品之零售業務。