Pharmaceutical Good Manufacturing Practice Regulations Article 129
Manufacturers shall require that their agents or distributors maintain and retain records of the distribution of medical devices and that such records are available for inspection.
中文原文 藥物優良製造準則第129條
製造業者應要求其輸入廠商或經銷商維護並保存醫療器材銷售紀錄，以備查核。