Medical Devices Act Article 21
Medical device manufacturers in Subparagraph 1 of Article 10 shall carry out factory registration pursuant to the Factory Management Act, except when exemption from factory registration is allowed pursuant to the Factory Management Act, or if such manufacture, as approved by the central competent authority, is for research and development purposes.
中文原文 醫療器材管理法第21條
從事第十條第一款製造之醫療器材製造業者，應依工廠管理輔導法規定，辦理工廠登記。
但依工廠管理輔導法規定免辦理工廠登記，或經中央主管機關核准為研發而製造者，不在此限。
但依工廠管理輔導法規定免辦理工廠登記，或經中央主管機關核准為研發而製造者，不在此限。