Pharmaceutical Good Manufacturing Practice Regulations Article 145
Where manufacturers destroy medical devices for use in clinical trials, destruction of aforesaid devices may not take place until all clinical trials and the final report are completed; detailed records shall be kept of the destruction process, and aforesaid records shall be preserved by the manufacturers.
中文原文 藥物優良製造準則第145條
製造業者對於臨床試驗用醫療器材之銷毀作業，不得在未完成所有臨床試驗及最後總合報告前進行；其銷毀，應製作銷毀紀錄記載所有相關之銷毀作業，並由製造業者保存之。