Regulations of Medicament Manufacturer Inspection Article 6
Domestic medical device manufacturers of the new establishment, relocation, expansion, resumption of operations, or addition of medical device products, shall apply for inspection by submitting a fee, along with two completed application forms and the following documents to the central competent health authority:(1) Quality manual;(2) A certificate of factory registration;(3) Permit license of pharmaceutical manufacturer.
中文原文 藥物製造業者檢查辦法第6條
新設、遷移、擴建、復業或增加醫療器材品項之國產醫療器材製造業者，應繳納費用，並填具申請書表二份及檢附下列資料，向中央衛生主管機關申請檢查：
一、品質手冊。
二、工廠登記證明文件。
三、製造業藥商許可執照。
一、品質手冊。
二、工廠登記證明文件。
三、製造業藥商許可執照。