Chapter 2 Assisted Reproduction Institution Permit Criteria
Section 2 Public Interest Judicial Persons
Article 13
A public interest judicial person shall not accept, store, or provide donated sperm unless and until applying to the competent authority and obtaining approval for establishing a sperm bank.
Article 14
Where a public interest organization applies for approval to establish a sperm bank, it shall meet the following criteria with respect to personnel, facilities, and equipment:
1. Holding an incorporated society or foundation registration certificate established for the public interest and non-profit.
2. Having at least one full-time quality management employee, and one of such employees designated as a director responsible for quality control of sperm inspection, storage, and other administrative matters.
3. Equipped with the facilities and equipment described in the attached Table 5.
Article 15
The quality management personnel described in Subparagraph 2 of the proceeding Article shall possess one of the following qualifications:
1. Possessing a medical technologist (assistant) certificate, and holding proof of at least three (3) months of training in sperm examination and assessment, freezing, and storage received at a medical care institution approved by the competent authority.
2. Meeting the qualifications of a technician prescribed under Subparagraph 2 of Paragraph 1 in Article 2.
The training referred to in Subparagraph 1 of the preceding paragraph shall be conducted at a medical care institution as prescribed in Subparagraph 1 of Paragraph 1 in Article 4.
Quality management personnel shall, every three (3) years, receive at least twelve (12) hours of continuing education in infertility, assisted reproductive technology, and reproductive endocrinology, or in psychology, ethics and law which courses are approved by the competent authority.
Article 16
Where a public interest society for the first time applies for permission to establish a sperm bank as provided in Paragraph 2 of Article 6 of this Act, it shall submit the following required documents:
1. Society or foundation registration certificate.
2. Personnel roster and documents verifying qualifications as prescribed in the preceding two Articles.
3. Relevant facilities and equipment specified in attached Table 5.
4. Freezing handbook, laboratory quality control handbook, and records of freezing operational quality control and instrument and equipment tests.
Article 17
Where an application as described in the proceeding article is received by the competent authority, a permit with three-year validity period may be issued unless and until the application passes documentary review and an on-site inspection.
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.
Article 19
Where a sperm bank fails to meet certain standards in the permit renewal review process as prescribed in the proceeding article, but requiring improvement within a prescribed period of time may be allowed under such circumstances, the competent authority may grant a provisional permit with no more than six months validity period with explicit statement of items to be improved and the corresponding deadline, or shall require the director of the sperm bank to receive at least 150 hours of training in one month period at a medical care institution as prescribed in Article 4, Paragraph 1, Subparagraph 1.
If the above-described sperm bank submits proof of improvement prior to the improvement deadline, and passes review, the competent authority shall issue a permit; such a permit is valid for three years from the date of the expiration of the original permit; where the sperm bank fails to submit the proof of improvement as described in the proceeding paragraph, it shall not continue to operate the sperm bank after expiration of the provisional permit.
Article 20
Where the director or other quality management personnel of a sperm bank changes, it shall report such changes to the competent authority within one month after the changes.
Article 21
A sperm bank shall ensure that its personnel, facilities, and equipment comply with all the provisions of these Regulations.
A sperm bank shall stop operating when it cannot provide services due to the resignation of a quality management employee or some other factors, even if the permit is still valid.
The competent authority shall revoke the permit of as perm bank that has violated the regulations of Paragraph 1, and has failed to make improvement after being notified to do so within a prescribed period of time.
Article 22
Donated sperm preserved in a sperm bank shall not be given to another medical care institution without the donor's prior written consent.
A sperm bank may provide part of the sperm donated by a single donor. Where the donated sperm is for second use by another medical care institution, the sperm bank shall not provide such sperm unless and until confirming that there is no remaining sperm from the donor, and there have been no live births or stored embryos resulting from that donor's sperm after the prior medical care institution has performed assisted reproduction.
Article 23
A sperm bank shall confirm that donors have received a health examination and assessment, and shall produce and adequately preserve records in compliance with Article 7, Paragraph 2 and Article 9, Paragraph 2 of this Act. While providing sperm to a medical care institution for use, a photocopy of the records regarding such sperm shall also be sent to that medical care institution for preservation.
A sperm bank shall continue to preserve the records as described in the proceeding paragraph for seven years after the sperm has been used or destroyed.