Regulations Governing Accreditation and Outsourced Accreditation Management of Drugs Testing Institutions Article 20
The independent provider shall meet the following requirements:1. Possession of the experiences required for the accreditation of testing institutions and the necessary documents supporting said eligibility.2. Employment of personnel meeting the following qualifications:(1) Graduates from the undergraduate or graduate program of a local college or university, or a foreign college or university and the academic records of which are recognized in accordance with the Regulations Governing the Assessment and Recognition of Foreign Academic Records by Institutions of Higher Education, with a major in food science, nutrition, biomedical engineering, medicine, chemistry, biology, life science, or other related disciplines, and with verified capabilities and experience performing inspection functions of inspection bodies;(2) Having completed studies of at least 15 academic credits of legal subjects involving civil law, criminal law, and administrative laws and regulations in a domestic university, with a transcript of records reflecting said credits.3. Fulfillment of all other requirements announced by the central competent health authority.
中文原文 藥物檢驗機構認證及委託認證管理辦法第20條
受託者應符合下列條件：
一、具備辦理檢驗機構認證所需之經驗，並能提出證明者。
二、聘有符合下列資格之人員：
（一）國內大專校院，或符合大學、專科學校辦理國外學歷採認相關法規規定之國外大專校院以上食品、營養、生物醫學工程、醫藥、化學、生物、生命科學或其他相關科、系、所畢業，並具有從事檢驗機構檢驗能力確認之經驗。
（二）修習國內大學開設之民事、刑事及行政法規課程總計十五個學分以上，並領有學分證明。
三、其他經中央衛生主管機關公告之條件。
一、具備辦理檢驗機構認證所需之經驗，並能提出證明者。
二、聘有符合下列資格之人員：
（一）國內大專校院，或符合大學、專科學校辦理國外學歷採認相關法規規定之國外大專校院以上食品、營養、生物醫學工程、醫藥、化學、生物、生命科學或其他相關科、系、所畢業，並具有從事檢驗機構檢驗能力確認之經驗。
（二）修習國內大學開設之民事、刑事及行政法規課程總計十五個學分以上，並領有學分證明。
三、其他經中央衛生主管機關公告之條件。