Medical Devices Act Article 79
The central competent authority may designate a subordinate agency (or institution) or commission another agency (or institution), or an accredited legal entity or organization to carry out education and training of technicians, review of registration and market approval of medical devices, issuance of certificates, review and inspection of clinical trials, review of advertisements, reporting of serious adverse events, and inspection or census of medical device firms.With the exception of education and training, the commissioned agency shall observe avoidance of conflicts of interest for matters related to designation or commissioning set forth in the preceding paragraph. Regulations governing its commissioning, accreditation, avoidance of conflicts of interest, and other related matters shall be established by the central competent authority.The central competent authority may designate a subordinate agency or commission another agency (or institution) to carry out the accreditation work as set forth in Paragraph 1. Regulations governing its designation, commissioning, and related matters shall be established by the central competent authority.
中文原文 醫療器材管理法第79條
本法關於技術人員之教育訓練、醫療器材之查驗登記審查、證明文件之核發、臨床試驗審查及查核、廣告審查、嚴重不良事件通報、醫療器材商檢查或普查等事項，主管機關得委任所屬機關（構），或委託其他機關（構）或經認證之法人或團體辦理。
前項委任或委託事項，除教育訓練外，受託者應遵守利益迴避原則；其委託、認證、利益迴避及其他相關事項之辦法，由中央主管機關定之。
第一項認證工作得委任所屬機關（構）或委託其他機關（構）辦理；其委任、委託及其相關事項之辦法，由中央主管機關定之。
前項委任或委託事項，除教育訓練外，受託者應遵守利益迴避原則；其委託、認證、利益迴避及其他相關事項之辦法，由中央主管機關定之。
第一項認證工作得委任所屬機關（構）或委託其他機關（構）辦理；其委任、委託及其相關事項之辦法，由中央主管機關定之。