Regulations Governing Laboratory Testing for Communicable Diseases and Management of Laboratory Testing Institutions Article 8
Testing institutions meeting the following qualifications may apply for the certification of testing institutions with the central competent authority or be certified directly by the central competent authority as a certified testing institutions:1. having been previously certified by a laboratory certification institution;2. having passed the laboratory proficiency test.The following documents shall be submitted when making the application of the preceding Paragraph:1. completed application form;2. documents certifying qualifications;3. standard operation procedures performed in the laboratory testing institutions;4.institutions that are equipped with the appropriate laboratory biosafety management manual or the relevant regulations brochure agreeing with the biosafety level of the specimens they are operating on.Health authorities, medical institutions, academic or research institutions using in-vitro diagnostic reagents approved by law may be certified by the central competent authority without being subject to the provisions of the first paragraph.The certified testing institutions are authorized to perform the laboratory testing of Category II, Category III, or Category IV communicable diseases specified in the Act only.
中文原文 傳染病檢驗及檢驗機構管理辦法第8條
符合下列資格之一者，得向中央主管機關申請或由中央主管機關認可為合格檢驗機構：
一、經實驗室認證機構認證通過。
二、經實驗室能力試驗合格。
前項申請，應檢具下列文件：
一、申請書。
二、資格證明文件。
三、標準檢驗方法。
四、備有與操作檢體相當等級之生物安全管理手冊或規定。
衛生機關、醫事機構、學術或研究機構使用依法核准之體外診斷試劑者，中央主管機關得認可為該試劑之合格檢驗機構，不受第一項規定之限制。
經認可之合格檢驗機構以辦理本法第二類、第三類或第四類傳染病之檢驗為限。
一、經實驗室認證機構認證通過。
二、經實驗室能力試驗合格。
前項申請，應檢具下列文件：
一、申請書。
二、資格證明文件。
三、標準檢驗方法。
四、備有與操作檢體相當等級之生物安全管理手冊或規定。
衛生機關、醫事機構、學術或研究機構使用依法核准之體外診斷試劑者，中央主管機關得認可為該試劑之合格檢驗機構，不受第一項規定之限制。
經認可之合格檢驗機構以辦理本法第二類、第三類或第四類傳染病之檢驗為限。