Regulations for Administration on Human Organ Bank Article 11
The central health authority will issue a three-year permit to an organ bank that has passed the onsite inspection.The permit mentioned in the preceding paragraph shall contain the following information:1. Name and address of the institution.2. The representative or responsible person of the institution.3. The type of organ bank.4. The location of the organ bank.5. The names of medical director and quality director.When there is change to the item mentioned in subparagraph 1, 2 or 5 of the preceding paragraph, an institution shall, within thirty (30) days after the occurrence of fact, apply for change of registration; when there is change to the item mentioned in subparagraph 3 or 4 of the preceding paragraph, an institution shall reapply for approval.An institution may, within three (3) months before the current permit for its organ bank expires, apply to the central health authority for extension of permit. An institution that has passed the review will receive a permit extension of up to three (3) years.
中文原文 人體器官保存庫管理辦法第11條
中央衛生主管機關對實地履勘通過之保存庫，發給三年效期之許可證明。
前項許可證明應記載下列事項：
一、機構名稱、地址。
二、機構代表人或負責人。
三、保存庫類別。
四、保存庫設置地點。
五、醫學主管及品質主管。
前項第一款、第二款或第五款記載之事項變更時，應於事實發生日起三十日內申請變更登記；第三款或第四款記載之事項變更時，應重新申請許可。
機構應於保存庫許可證明效期屆滿前三個月，向中央衛生主管機關申請展延。
其經審查通過者，每次展延以三年為限。
前項許可證明應記載下列事項：
一、機構名稱、地址。
二、機構代表人或負責人。
三、保存庫類別。
四、保存庫設置地點。
五、醫學主管及品質主管。
前項第一款、第二款或第五款記載之事項變更時，應於事實發生日起三十日內申請變更登記；第三款或第四款記載之事項變更時，應重新申請許可。
機構應於保存庫許可證明效期屆滿前三個月，向中央衛生主管機關申請展延。
其經審查通過者，每次展延以三年為限。