Standards for Medicament Factory Establishments Article 33
Facilities at medical device factories shall be installed based on actual manufacturing needs; facilities used in the inspection and testing of products to ensure product compliance shall be appropriately monitored, managed, rectified and maintained.
中文原文 藥物製造工廠設廠標準第33條
醫療器材製造工廠，其設備應視產品實際需要設置之；對其用以證明產品符合規定要求之檢驗、量測及試驗設備，應予記錄、管制、校正及維護。