Medical Devices Act Article 20
The facilities, equipment, and sanitary conditions of medical device manufacturers shall comply with the Establishment Standards for Medical Device Manufacturers.The Establishment Standards for Medical Device Manufacturers set forth in the preceding paragraph shall be jointly prescribed by the central competent authority and central industry competent authority.
中文原文 醫療器材管理法第20條
醫療器材製造業者之場所設施、設備及衛生條件，應符合醫療器材製造業者設置標準。
前項醫療器材製造業者設置標準，由中央主管機關會同中央工業主管機關定之。
前項醫療器材製造業者設置標準，由中央主管機關會同中央工業主管機關定之。