Medical Care Act Article 105
This English translation was last updated on 2023-06-28, but the Chinese text was amended on 2026-09-23. Later amendments may not be reflected in the translation — please refer to the Chinese text.
Persons who violate any of the provisions of Paragraph 1 or 2 of Article 78 herein by administering human research without the approval, entrustment or consent of the central competent authority, shall be subject to a fine of no less than NT$200,000 but no more than NT$1,000,000, and be ordered to suspend or terminate the human research by the central competent authority. Violations of a serious nature shall also be subject to suspension of practice for no less than one month but no more than one year or revocation of practice license.Persons who violate any of the provisions of Paragraph 3 of Article 78 herein or any regulations about the review benchmark stipulated by the central competent authority in accordance with Article 79-1 shall be subject to a fine of no less than NT$100,000 but no more than NT$500,000 by the central competent authority, and be ordered to discontinue the human research or the review set forth in Paragraph 3 of Article 78.Persons who violate any of the provisions of Article 79, Article 79-2, Paragraph 1 of Article 80 herein or the regulations governing the supervision and management or review criteria set forth by the central competent authority pursuant to Article 79-1 herein shall be subject to a fine of no less than NT$100,000 but no more than NT$500,000 by the central competent authority, and in addition, be ordered to discontinue the human research if the safety of the research or damage to the interests of the research subjects is a concern. Violations of a serious nature shall also be subject to cessation of practice for whole or part of relevant business or for departments and services that violate the provisions for no less than one month but no more than one year.Persons who violate any of the provisions of Paragraph 4 of Article 78 herein shall be subject to a fine of no less than NT$50,000 but no more than NT$250,000 by the central competent authority, and in addition, be ordered to discontinue the human research. Violations of a serious nature shall also be ordered to terminate the human research.
中文原文 醫療法第105條
違反第七十八條第一項或第二項規定，未經中央主管機關核准、委託或同意，施行人體試驗者，由中央主管機關處新臺幣二十萬元以上一百萬元以下罰鍰，並令其中止或終止人體試驗；情節重大者，並得處一個月以上一年以下停業處分或廢止其開業執照。
違反第七十八條第三項或中央主管機關依第七十九條之一授權所定辦法有關審查作業基準者，由中央主管機關處新臺幣十萬元以上五十萬元以下罰鍰，並得令其中止該項人體試驗或第七十八條第三項所定之審查。
違反第七十九條、第七十九條之二、第八十條第一項或中央主管機關依第七十九條之一授權所定辦法有關監督管理或查核事項之規定者，由中央主管機關處新臺幣十萬元以上五十萬元以下罰鍰，有安全或損害受試者權益之虞時，另得令其終止人體試驗；情節重大者，並得就其全部或一部之相關業務或違反規定之科別、服務項目，處一個月以上一年以下停業處分。
違反第七十八條第四項規定者，由中央主管機關處新臺幣五萬元以上二十五萬元以下罰鍰，並令其中止該人體試驗；情節重大者，並得令其終止該人體試驗。
違反第七十八條第三項或中央主管機關依第七十九條之一授權所定辦法有關審查作業基準者，由中央主管機關處新臺幣十萬元以上五十萬元以下罰鍰，並得令其中止該項人體試驗或第七十八條第三項所定之審查。
違反第七十九條、第七十九條之二、第八十條第一項或中央主管機關依第七十九條之一授權所定辦法有關監督管理或查核事項之規定者，由中央主管機關處新臺幣十萬元以上五十萬元以下罰鍰，有安全或損害受試者權益之虞時，另得令其終止人體試驗；情節重大者，並得就其全部或一部之相關業務或違反規定之科別、服務項目，處一個月以上一年以下停業處分。
違反第七十八條第四項規定者，由中央主管機關處新臺幣五萬元以上二十五萬元以下罰鍰，並令其中止該人體試驗；情節重大者，並得令其終止該人體試驗。