Regulations for Assisted Reproduction Institution Permit Article 9
Where an institution fails to meet certain standards in the permit renewal review process as prescribed in the proceeding article, the competent authority may grant such Institution a provisional permit of less than six months validity, which shall explicitly state items to be improved and the corresponding time-limit.Where items described in the preceding paragraph concerning the standard in which the cumulative live birth rate among treatment cycles for patients less than 38 years old is less than 9% (round off to the first decimal place), the following methods may be adopted to improve the rate:1.The Institution's director or operating physician shall receive at least 180 hours of training in a three-month period at a medical care institution as described in Paragraph 3 of Article 3 within six months after the expiration of the original permit; the technicians of such Institution shall receive at least 180 hours of training in a three-month period at a medical care institution as described in Subparagraph 1 of Paragraph 1 in Article 4.2.Where an Institution's director, operating physicians or technicians refuse training, such institution shall recruit a new director who is not the original director or operating physician of the institutions within six (6) months after the expiration of the original permit; the same requirement applies mutatis mutandis to the recruitment of new technicians.Institutions obtaining permit renewal pursuant to Subparagraph 1 of Paragraph 2 shall be limited to once only.An institution shall not accept new cases within the provisional permit period. If the Institution submits proof of improvement prior to the improvement deadline, and passes review, the competent authority shall issue that Institution a permit; such permit shall be valid for three years from the date of the expiration of the original permit. Where an institution fails to submit proof of improvement, it shall not continue to perform assisted reproduction services after the expiration of the provisional permit.
中文原文 人工生殖機構許可辦法第9條
機構經依前條規定審查未達一定基準者,主管機關得發給六個月以內效期之臨時許可,並載明應改善事項及其期限。
前項應改善事項涉及未滿三十八歲前,其治療週期累積活產率百分之九以下者(以小數點一位數,四捨五入方式計算),得採取下列方式改善:
一、主持人或施術醫師應自原效期屆滿之日起六個月內,於符合第三條第三項所定醫療機構,接受三個月至少一百八十小時之訓練;其技術員應於符合第四條第一項第一款所定醫療機構,接受三個月至少一百八十小時之訓練。
二、主持人、施術醫師及技術員不接受訓練者,得自原效期屆滿之日起六個月內,重新聘請非原機構之主持人或施術醫師為主持人及非原機構技術員為技術員。
採用第二項第一款規定取得再次許可者,以一次為限。
機構於臨時許可期間內不得接受新案。
其於改善期限屆至前提出改善證明,經主管機關審查通過者,發給許可證書;許可證書效期自原許可效期屆滿之翌日起算三年;未能提出改善證明或改善證明審查未通過者,自臨時許可期間屆滿翌日起,不得繼續施行人工生殖業務。
前項應改善事項涉及未滿三十八歲前,其治療週期累積活產率百分之九以下者(以小數點一位數,四捨五入方式計算),得採取下列方式改善:
一、主持人或施術醫師應自原效期屆滿之日起六個月內,於符合第三條第三項所定醫療機構,接受三個月至少一百八十小時之訓練;其技術員應於符合第四條第一項第一款所定醫療機構,接受三個月至少一百八十小時之訓練。
二、主持人、施術醫師及技術員不接受訓練者,得自原效期屆滿之日起六個月內,重新聘請非原機構之主持人或施術醫師為主持人及非原機構技術員為技術員。
採用第二項第一款規定取得再次許可者,以一次為限。
機構於臨時許可期間內不得接受新案。
其於改善期限屆至前提出改善證明,經主管機關審查通過者,發給許可證書;許可證書效期自原許可效期屆滿之翌日起算三年;未能提出改善證明或改善證明審查未通過者,自臨時許可期間屆滿翌日起,不得繼續施行人工生殖業務。