Medical Devices Act Article 78
The central competent authority may carry out accreditation of the relevant agency (or institution), legal entity, organization, or private institution commissioned to conduct testing, as set forth in the preceding article. Regulations governing their accreditation and management shall be established by the central competent authority.The central competent authority may designate a subordinate agency or commission another agency (or institution), legal entity, organization, or private institution to carry out the accreditation work as set forth in the preceding paragraph. Regulations governing its designation, commissioning, and related matters thereof shall be established by the central competent authority.
中文原文 醫療器材管理法第78條
中央主管機關得就前條受託檢驗之法人、團體,辦理認證;其認證及管理辦法,由中央主管機關定之。
前項認證工作,得委任所屬機關(構)或委託其他機關(構)、法人或團體辦理;其委任、委託及其相關事項之辦法,由中央主管機關定之。
前項認證工作,得委任所屬機關(構)或委託其他機關(構)、法人或團體辦理;其委任、委託及其相關事項之辦法,由中央主管機關定之。