Regulations for Assisted Reproduction Institution Permit Article 18
A sperm bank applying for permit renewal shall submit the following documents to the competent authority within three months prior to the expiration of the permit:1. The relevant facilities, equipment, and maintenance records as prescribed in attached Table 5.2. The documents as prescribed in Subparagraphs 1 to 3 of Article 16.3. The freezing and laboratory quality control operating handbooks.4. The laboratory quality control and management process records.An on-site inspection may be conducted whenever necessary for a permit renewal review.Attached Table 5 Facilities and equipment requirements for a public interest registered society applying to establish a sperm bank.PDF
中文原文 人工生殖機構許可辦法第18條
精子保存庫於許可證書有效期間屆滿三個月前，應檢附下列文件送請主管機關申請再次許可：
一、附表五所定之相關設施、設備及保養維修紀錄。
二、第十六條第一款至第三款所定文件。
三、冷凍作業與實驗室品質管制等作業手冊。
四、實驗室品質管制作業與管理流程等紀錄。
再次許可之審查，必要時得辦理實地查核。
一、附表五所定之相關設施、設備及保養維修紀錄。
二、第十六條第一款至第三款所定文件。
三、冷凍作業與實驗室品質管制等作業手冊。
四、實驗室品質管制作業與管理流程等紀錄。
再次許可之審查，必要時得辦理實地查核。