Medical Devices Act Article 38
Clinical trial institutions and trial sponsors shall report to the central competent authority when the human subject of a medical device clinical trial experiences any of the following occurrences during implementation of the clinical trial:1. Death.2. Life-threatening condition.3. Temporary or permanent disability.4. Congenital anomaly of fetus or infant of the human subject.5. Requiring hospitalization or prolonged hospitalization.6. Other complications that may result in permanent injuries.Clinical trial institutions shall report to the central competent authority when the human subject experiences any of the occurrences in the preceding paragraph after termination of the clinical trial and when the occurrence is related to the clinical trial.The reporting set forth in the preceding two paragraphs shall be made within seven days after becoming aware of the actual happening of the occurrence, and detailed investigation information shall be submitted to the central competent authority within fifteen days for recordation.
中文原文 醫療器材管理法第38條
醫療器材臨床試驗之受試者，於臨床試驗施行期間發生下列情事之一者，臨床試驗機構及試驗委託者應通報中央主管機關：
一、死亡。
二、危及生命。
三、暫時或永久性失能。
四、受試者之胎兒或嬰兒先天性畸形。
五、需住院或延長住院。
六、其他可能導致永久性傷害之併發症。
臨床試驗終止後，受試者發生前項情事之一，且與臨床試驗有關者，臨床試驗機構應通報中央主管機關。
前二項通報，應於得知事實後七日內為之，並於十五日內檢具詳細調查資料，報中央主管機關備查。
一、死亡。
二、危及生命。
三、暫時或永久性失能。
四、受試者之胎兒或嬰兒先天性畸形。
五、需住院或延長住院。
六、其他可能導致永久性傷害之併發症。
臨床試驗終止後，受試者發生前項情事之一，且與臨床試驗有關者，臨床試驗機構應通報中央主管機關。
前二項通報，應於得知事實後七日內為之，並於十五日內檢具詳細調查資料，報中央主管機關備查。