Pharmaceutical Good Manufacturing Practice Regulations Article 140
The design, development, manufacture, processing, packaging, storage, installation method and facility of medical devices for use in clinical trials shall, unless otherwise regulated by regulations of this Chapter, be governed by regulations of Chapter 2 in this Part.
中文原文 藥物優良製造準則第140條
臨床試驗用醫療器材，除本章之特別規定外，其設計與開發、製造、加工、包裝、儲存及安裝之方法、設施，適用本編第二章之規定。