Pharmaceutical Good Manufacturing Practice Regulations Article 144
Where manufacturers have medical devices for use in clinical trials manufactured or tested on a contract basis, aforesaid contract shall clearly state that the product in question is for use in clinical trials only.
中文原文 藥物優良製造準則第144條
製造業者對於臨床試驗用醫療器材委託製造及檢驗者，其委託契約應明確規定該產品限供臨床試驗之用。