Regulations for Administration on Human Organ Bank Article 9
An institution that plans to establish an organ bank shall submit the following documents when applying to the central health authority for approval:1. Establishment plan, which shall include descriptions of the responsible person of the institution, and address of the institution and the proposed organ bank, type of organ bank, estimated storage space, medical director, quality director, progress of establishment, quality management system, organization and staff, operating procedures, facilities and premises, environmental control and monitoring, equipment, label control, recovery, storage, delivery, receiving, tracking and destruction of organs.2. Documents evidencing the qualifications of the medical director and the quality director.3. A simple layout of the operational and storage premises.
中文原文 人體器官保存庫管理辦法第9條
機構設置保存庫，應檢具下列文件，向中央衛生主管機關申請許可：
一、設置計畫書，內容應包括機構負責人、機構及保存庫地址、保存庫類別、預估保存量、醫學主管、品質主管、設置進度、品質管理系統、組織與人員、作業程序、設施與場所、環境管制與監控、設備、標示管制、採集、貯存、配送、收受、追蹤及銷燬之說明。
二、醫學主管及品質主管之資格證明文件。
三、作業及保存場所之平面簡圖。
一、設置計畫書，內容應包括機構負責人、機構及保存庫地址、保存庫類別、預估保存量、醫學主管、品質主管、設置進度、品質管理系統、組織與人員、作業程序、設施與場所、環境管制與監控、設備、標示管制、採集、貯存、配送、收受、追蹤及銷燬之說明。
二、醫學主管及品質主管之資格證明文件。
三、作業及保存場所之平面簡圖。