Regulations for Administration on Human Organ Bank Article 8

An organ bank shall prepare the following documents and retain them along with the human organ it preserves:1. A letter of consent from the donor, except for one of the following circumstances:(1) In case of an organ transfer, a permit certificate from the recovery organ bank has been presented.(2) In case of an imported organ, a donor consent certificate from the source institution has been presented.2. A eligibility certificate of the donor.3. In case of an imported organ, a document to prove its approval of importation.4. A report for the result of tests and other necessary processing prescribed in the preceding article.5. A description or record on the preservation status of the human organ.Where a human organ is transferred to another organ bank, a copy of the documents mentioned in the preceding paragraph shall be transferred concurrently.An organ bank shall retain the documents mentioned in the preceding paragraph 1 and 2, for at least another ten (10) years after the human organ concerned has been destroyed or if there is no leftover or derivative of the human organ being preserved after its use.
中文原文 人體器官保存庫管理辦法第8條
保存庫保存人體器官應備齊下列文件一併保存:
一、捐贈者之同意書。
但有下列情形之一者不在此限:
(一)移轉之器官,已檢具原採集保存庫許可證明文件。
(二)輸入之器官,已檢具來源單位之捐贈者同意之證明文件。
二、捐贈者合適性證明文件。
三、輸入之器官,經核准輸入之證明文件。
四、前條所定之檢驗及其他必要處理之報告。
五、人體器官保存狀態之說明或紀錄。
前項文件,於人體器官移轉至其他保存庫,應將影本一併移轉。
保存庫之人體器官經銷燬或經使用後已無餘留物或衍生物保存者,前二項文件,應至少再保存十年。

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