Chapter 2 Assisted Reproduction Institution Permit Criteria
Section 1 Medical Care Institutions
Article 2
A medical care institution applying for a permit to operate as an assisted reproduction institution (hereinafter referred to as “Institution”) shall be equipped with the following personnel, facilities, and equipment:
1. Personnel:
(1) Full-time operating physician shall likewise serve as the director of the Institution: a gynecologist/obstetrician who has undergone certain training and has practiced as a full-time operating physician shall likewise serve as the director of the Institution. Where an institution employs two or more surgeons, one of them shall be designated as the director.
(2) Full-time technician: a person who possesses a bachelors degree or higher in biology-related departments listed in Table 1 (attached) and has undergone certain training.
(3) Full-time or part-time counselors: medical personnel or social workers who have undergone specific training.
2. Facilities and equipment: as prescribed in Table 1.
Article 3
The specific training prescribed in Subparagraph 1 of Paragraph 1 in the preceding article shall be as follows:
1. At least two (2) years of clinical training in infertility, assisted reproductive technology, and reproductive endocrinology from a medical care institution approved by the competent authority. Trainees must have participated in at least forty (40) operations during the training period.
2. After completing one full year of the specialized training referred in the preceding paragraph, an operating physician must also receive at least 36 hours of continuing education classes with respect to infertility, assisted reproductive technology, reproductive endocrinology, psychology and ethics approved by the competent authority every three years, in which the classes of psychology, ethics and law shall be no less than five (5) hours.
Verifying documents listing relevant training content, supervising physicians and details of actual operations in connection with the training as prescribed in Subparagraph 1 of the preceding paragraph shall be obtained.
The medical care institution described in Subparagraph 1 of Paragraph 1 shall refer to a medical center or teaching hospital affiliated to a college of medicine accredited by the competent authority, and shall conduct at least 100 oocyte removal cycles annually along with more than 25% (rounded off to the first decimal place) cumulative live births of treatment cycles for patients less than 38 years old.
The clinic medical training referred to in Paragraph 1 of Subparagraph 1 shall be performed after completion of specialist training in obstetrics and gynecology. A period registered of practice shall be at least one (1) year of service at the same medical care institution.
Article 4
The specific training referred to in Subparagraph 2 of Paragraph 1 of Article 2 shall be as follows:
1. At least one year of training in the handling, incubation, and freezing of human sperm and oocytes, in the fertilization process, and in the assessment of embryo quality at a medical care institution approved by the competent authority, and having performed at least twenty (20) individual instances of in vitro fertilization during the training period.
2. At least eighteen (18) hours of continuing education classes with respect to infertility, assisted reproductive technology, reproductive endocrinology, psychology and ethics approved by the competent authority every three years, in which the classes of psychology, ethics and law shall be no less than three (3) hours.
For quality assessment training referred to in the preceding Paragraph 1, a verifying document listing related training content and details of in vitro fertilization cases shall be obtained.
The medical care institution described in Subparagraph 1 of Paragraph 1 shall conduct at least fifty (50) oocyte removal cycles annually along with more than 25% (rounded off to the first decimal place) cumulative live births of treatment cycles for patients less than 38 years old.
Article 5
The specific training referred to in Subparagraph 3 of Paragraph 1 of Article 2 shall be as follows:
1. A minimum of three months of training courses in infertility, assisted reproductive technology, counseling and related laws received from a medical care institution accredited by the competent authority.
2. At least eighteen (18) hours of continuing education classes in every three years covering infertility, assisted reproductive technology, reproductive endocrinology, counseling, psychology, ethics and law, approved by the competent authority, and in which the classes of psychology, ethics and law shall be no less than three (3) hours.
Verifying documents containing relevant training content shall be obtained for the training described in the preceding paragraph.
Article 6
A medical care institution applying for a first permit in accordance with the regulations of this Act shall submit the following documents:
1. Photocopy of business license.
2. Roster of the personnel as prescribed from Article 2 to the proceeding article and documents verifying qualifications.
3. List and facilities and equipment as prescribed in Article 2, Subparagraph 5.
4. A working handbook shall include:
(1) Preparation of culture medium.
(2) Preparation of sperm and oocytes and insemination.
(3) Grading of oocytes and embryos.
(4) Microscopic operations.
(5) Freezing and defrosting; operating procedures for computerized freezer or equivalent frozen embryo equipment.
(6) CO2 incubator testing specifications.
(7) Embryo room quality control measures.
5. CO2 incubator testing records, computerized freezer or equivalent frozen embryo equipment operating testing records.
Article 7
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 8
An institution applying for a permit renewal review shall submit the documents listed in the Assisted Reproduction Institution Permit Renewal Application Review Item Form (Attached Table 3) to the competent authority within three months prior to the expiration of the permit, and request the competent authority to perform a review in accordance with the Assisted Reproduction Institution Permit Renewal Review Items, Standards, and Point Distribution Table (Attached Table 4).
An on-site inspection may be conducted whenever necessary for a permit renewal review.
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.
Article 10
Where an Institution applies for a permit within three (3) years after the expiration of the original permit, its re-application for permit shall comply with regulations under Article 8; re-application for permit after the expiration of the original permit over three (3)years shall comply with regulations under Article 6.
Article 11
Where the director or an operating physician or technician of an Institution changes, it shall report such changes to the competent authority within one month after the changes.
Article 12
An Institution shall ensure that its personnel, facilities, and equipment comply with all the provisions of these Regulations.
An Institution shall not perform assisted reproduction services if it cannot provide assisted reproduction services due to the resignation of an operating physician or technician or some other factors, even if the permit is still valid.
The competent authority shall revoke the permit of an Institution 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.