Human Biobank Management Act Article 4
A Biobank Operator must be a governmental agency, medical or academic institution, research institution, or legal person (hereinafter collectively referred to as “Organization”) and shall apply to the Competent Authority for a permit.The Competent Authority shall stipulate rules and regulations to govern matters related to the permit applications mentioned in the preceding paragraph, such as applicant qualifications, application procedures, conditions for the establishment approval, review standards, regular inspections, relevant managerial matters, and other matters of compliance.
中文原文 人體生物資料庫管理條例第4條
生物資料庫之設置者，以政府機關、醫療或學術機構、研究機構、法人（以下統稱機構）為限，並應向主管機關申請許可。
前項申請者之資格、申請程序、許可設置之條件、審查基準、定期查核、相關管理及其他應遵行事項之辦法，由主管機關定之。
前項申請者之資格、申請程序、許可設置之條件、審查基準、定期查核、相關管理及其他應遵行事項之辦法，由主管機關定之。