Regulations Governing Accreditation and Outsourced Accreditation Management of Drugs Testing Institutions Article 6
The central competent health authority shall conduct a document review and on-site assessment on the applications of testing institutions.Where the on-site assessment finds a deficiency, the testing institutions shall submit a corrective plan to the central competent health authority for re-assessment after the end of on-site assessment within 60 days.
中文原文 藥物檢驗機構認證及委託認證管理辦法第6條
中央衛生主管機關對於檢驗機構之申請,應進行書面審查及實地查核。
實地查核結果認有缺失者,檢驗機構應依實地查核之報告,自查核結束之日起六十日內,將改善報告送中央衛生主管機關進行複評。
實地查核結果認有缺失者,檢驗機構應依實地查核之報告,自查核結束之日起六十日內,將改善報告送中央衛生主管機關進行複評。