Pharmaceutical Affairs Act Article 85

Any person who manufactures or imports the substandard drugs set forth in Subparagraph 1 of Article 21 hereof or the defective medical devices set forth in Subparagraph 1 or Subparagraph 2 of Article 23 hereof shall be punished with imprisonment of not more than five (5) years, or detention, and may, in addition thereto, be imposed a fine of not more than NT$50,000,000.Any person who commits the aforementioned offense by negligence or knowingly sells, supplies, dispenses, transports, stores, brokers, transfers, or displays with intent to sell the substandard drugs or defective medical devices set forth in the preceding paragraph shall be punished with imprisonment of not more than three (3) years or detention and may, in addition thereto, be imposed a fine of not more than NT$10,000,000.Any person who, by negligence, sells, supplies, dispenses, transports, stores, brokers, transfers, or displays with intent to sell the substandard drugs or the defective medical devices set forth in the first paragraph hereof shall be punished with detention or a fine of not more than NT$1,000,000.
中文原文 藥事法第85條
製造或輸入第二十一條第一款之劣藥或第二十三條第一款、第二款之不良醫療器材者,處五年以下有期徒刑或拘役,得併科新臺幣五千萬元以下罰金。
因過失犯前項之罪或明知為前項之劣藥或不良醫療器材,而販賣、供應、調劑、運送、寄藏、牙保、轉讓或意圖販賣而陳列者,處三年以下有期徒刑或拘役,得併科新臺幣一千萬元以下罰金。
因過失而販賣、供應、調劑、運送、寄藏、牙保、轉讓或意圖販賣而陳列第一項之劣藥或不良醫療器材者,處拘役或科新臺幣一百萬元以下罰金。

English translation for reference only; the Chinese text prevails. Not legal advice.