Pharmaceutical Good Manufacturing Practice Regulations Article 142
Where manufacturers provide medical devices for use in clinical trials, aforesaid devices, in addition to conforming to regulations governing labeling in the Act, must also be labeled “for use in clinical trials only”, and marked with the name of the trial sponsor and a trial code sufficient to identify the trial site and research personnel involved.
中文原文 藥物優良製造準則第142條
製造業者對於臨床試驗用醫療器材之標示，除須符合本法有關規定外，應另標示「臨床試驗專用」、試驗委託者名稱及足以確認試驗場所、研究人員之試驗編號。