Medical Devices Act Article 23
Medical device manufacturers shall not commission other manufacturers to manufacture or accept the commissioning to manufacture medical devices, unless otherwise approved by the central competent authority.Medical device dealers shall not manufacture medical devices. However, this shall not apply to those approved by the central competent authority to commission other medical device manufacturers for the manufacture.Regulations governing the application documents, product liability, contractual provisions, labeling, packaging for the commissioning of manufacture referred to in the preceding two paragraphs, and other operation related matters to be complied with shall be established by the central competent authority.
中文原文 醫療器材管理法第23條
醫療器材製造業者，非經中央主管機關核准，不得委託其他製造業者製造或接受委託製造醫療器材。
醫療器材販賣業者不得製造醫療器材。
但經中央主管機關核准其委託其他醫療器材製造業者製造者，不在此限。
前二項委託製造之申請文件、產品責任、契約規定、標籤、包裝及其他相關作業事項之準則，由中央主管機關定之。
醫療器材販賣業者不得製造醫療器材。
但經中央主管機關核准其委託其他醫療器材製造業者製造者，不在此限。
前二項委託製造之申請文件、產品責任、契約規定、標籤、包裝及其他相關作業事項之準則，由中央主管機關定之。