Pharmaceutical Affairs Act Article 84
Any person who manufactures or imports medical devices without obtaining prior approval shall be punished with imprisonment of not more than three (3) years and may, in addition thereto, be imposed with a fine of not more than NT$10,000,000.Any person who knowingly sells, supplies, transports, stores, brokers, transfers, or displays with intent to sell the medical devices set forth in the preceding paragraph shall be subject to the punishment set forth in the preceding paragraph.Any person who commits the offense set forth in the preceding paragraph by negligence shall be punished with imprisonment of not more than six (6) months, detention, or a fine of not more than NT$5,000,000.
中文原文 藥事法第84條
未經核准擅自製造或輸入醫療器材者，處三年以下有期徒刑，得併科新臺幣一千萬元以下罰金。
明知為前項之醫療器材而販賣、供應、運送、寄藏、牙保、轉讓或意圖販賣而陳列者，依前項規定處罰之。
因過失犯前項之罪者，處六月以下有期徒刑、拘役或科新臺幣五百萬元以下罰金。
明知為前項之醫療器材而販賣、供應、運送、寄藏、牙保、轉讓或意圖販賣而陳列者，依前項規定處罰之。
因過失犯前項之罪者，處六月以下有期徒刑、拘役或科新臺幣五百萬元以下罰金。