Regulations for Artificial Reproduction Institution Permit
Chapter 1 General Principles
Article 1 These Regulations are prescribed pursuant to Article 6, Paragraph 3 of the
Artificial Reproduction Act (hereinafter referred to as "this Act").
Chapter 2 Artificial Reproduction Institution Permit Criteria
Section 1 Medical Care Institutions
Article 2 A medical care institution applying for a permit to operate as an artificial
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, artificial 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, artificial
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
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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, artificial 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, artificial
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, artificial 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.
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Article 8 An institution applying for a permit renewal review shall submit the
documents listed in the Artificial 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 Artificial
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 artificial 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 artificial reproduction services if it
cannot provide artificial reproduction services due to the resignation of an
operating physician or technician or some other factors, even if the permit
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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.
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 14Where 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.
Article15The 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, artificial reproductive
technology, and reproductive endocrinology, or in psychology, ethics and law
which courses are approved by the competent authority.
Article16Where 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.
Article18A 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.
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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 a sperm 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 artificial 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.
Chapter 3 Supplementary Provisions
Article 24 Any Institution and its personnel shall be obligated to maintain the
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confidentiality of a third party's private information known or obtained
while practicing, and shall not divulge it without cause.
Article 25The competent authority may conduct an on-site inspection whenever
necessary; the Institution and its personnel shall provide their cooperation,
and shall not attempt to evade, obstruct, or refuse the inspection.
Article 26 Where an Institution accepts donated sperm in accordance with Article 8,
Paragraph 1 of this Act, it shall perform a second HIV test on the sperm
donor after his sperm has been frozen for six months, and shall provide the
sperm for use unless and until confirming that the donor is not infected.
Article 27The competent authority may entrust its subordinate Health Promotion
Administration or relevant organizations to carry out the training,
continuing education, review of personnel qualifications, permit of
institutions and other relevant matters prescribed in these Regulations.
Article 28 Where a medical care institution applies for a permit within one year after
these Regulations take effect, proof of receiving continuing education of
the institution's operating physicians, technicians, and counselors can be
exempted.
Article 29 Where a medical care institution submitting an application in accordance
with Article 39 of this Act may be exempted from the on-site inspection
requirement prescribed in Article 7; where an institution passes
documentary review, the validity period of its permit shall be limited to the
period approved prior to the implementation of these Regulations.
Article 30 An operating physician who possesses any of the following qualifications
prior to the implementation of these Regulations, he/she may apply for
qualification approval within one year after the implementation of these
Regulations without regard to the requirements prescribed in Article 3:
1. He/she has received director qualifications approved by the competent
authority on the basis of the Assessment Criteria for Medical Care
Institutions of Assisted Reproductive Technology (hereinafter referred to as
"Assessment Criteria").
2. He/she has complied with the training regulations of Assessment Criteria
prior to the promulgation of these Regulations, and continued to practice
artificial reproduction services after completing training.
3. He/she has complied with the training regulations of Assessment Criteria
prior to the promulgation of these Regulations, but did not perform any
relevant technical procedures within five years after completing training; the
physician received at least 180 hours of training during a three-month period
in a medical care institution announced by the competent authority in
accordance with Article 3, Paragraph 3, and has obtained a document
providing proof of qualifications.
Where the physician possesses the qualification as prescribed in
Subparagraphs 2 and 3 of the proceeding paragraph, he/she shall receive an
average of at least 12 hours of continuing education annually from June
2004 in order to comply with the revised regulations of Assessment Criteria
announced on June 25, 2004.
Article 31 A technician who possesses any of the following qualifications prior to
the implementation of these Regulations, he/she may apply for qualification
approval within one year after the implementation of these Regulations
without regard to the requirements prescribed in Article 4:
1. He/she has been qualified as a technician approved by the competent
authority in accordance with Assessment Criteria.
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2. He/she has complied with the training requirements of Assessment Criteria
prior to the announcement of these Regulations, and continued to practice
artificial reproduction services after completing training.
Where a technician possesses the qualification as prescribed in
Subparagraphs 2 of the proceeding paragraph, he/she shall receive an
average of at least 8 hours of continuing education annually from June 2004
in order to comply with the revised regulations of Assessment Criteria
announced on June 25, 2004.
Article 32
These Regulations shall take effect on the date of promulgation.
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Attached Table 1 The list of biologically relevant departments and
institutes for qualified technicians of an artificial reproduction
institution
1. Department of Medicine
2. Department of Traditional Chinese Medicine
3. Department of Dentistry
4. Department of Pharmacy
5.Department of Medical Laboratory Science and Biotechnology
6. Department of Nursing
7. Department of Food, Nutrition and Health Sciences
8. Department of Physical Therapy
9. Department of Occupational Therapy
10. Department of Medical Radiation Technology
11. Department of Respiratory Therapy
12. Department of Psychology
13. Department of Animal Science
14. Department of Zoology
15. Department of Cell Biology
16. Department of Life Sciences
17. Department of Biotechnology
18. Department of Biochemistry
19. Department of Microbiology
20. Department of Biology
21. Department of Animal Husbandry
22. Department of Physiology
23. Department of Fisheries
24. Department of Aquatic Food Science
25. Department of Veterinary Medicine
26. Department of Entomology
27. Department of Animal Science
28. Department of Biomedicine
29. Department of Biomedical
30. Department of Aquatic Biology
31. Department of Agricultural Chemistry
32. Department of Molecular Biology
33. Other Departments approved by the Ministry of Health and Welfare
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Attached Table 2 Facilities and equipment requirements for a medical care
institution applying to establish an artificial reproduction institution
1. Surgical room: shall comply with surgical room establishment
regulations prescribed in the Medical Care Institution Establishment
Standards.
2. Separate embryo room
3. Phase contrast inverted microscope and warm carriers
4. Dissecting microscope and warming equipment
5. Laminar flow hood
6. Two or more CO2 incubators
7. Water bath
8. Centrifuge
9. pH meter
10. Osmometer
11. Computerized freezer or equivalent embryo freezing equipment
12. Liquid nitrogen storage tank, freezing bottle, or freezing tube
13. High-pressure autoclave
14. Ultrasound equipment and ultrasonic vaginal oocyte removal
equipment
15. Micro-manipulation equipment
16. Pure water generator
17. Sperm counter
18. Shaking device
19. Analytical balance
20. Dry container for medicine storage
21. Backup power supply
22. Ordinary optical microscope
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Attached Table 3 Artificial reproduction institution permit renewal
application review item form
1.
Photocopy of practice license;
2.
Personnel roster and qualification certificates specified in Article 2; (Those
whose qualification has been approved by the competent authority are not
required to provide qualification certificates.)
3.
Training completion certificates of operating physicians, technicians, and
counselors as required in Articles 3, 4, and 5;
4.
Personnel work performance assessment;
5.
List of facilities and equipment prescribed in the attached Table 2;
6.
Records of laboratory equipment maintenance and repair conducted by
assigned personnel;
7.
The following operation manuals:
(1) Preparation of culture medium;
(2) Sperm and oocytes preparation and insemination;
(3) Grading of oocytes and embryos;
(4) Micro-manipulation;
(5) Cryopreservation and thawing procedures, and operating procedures of
computer-controlled freezer or equivalent embryo freezing equipment;
(6) CO2 incubator testing specifications;
(7) Embryo room quality control measures
8.
Laboratory quality control
(1) Records of relevant operation procedures; (AR Institutions handling 20 or
more cases within the three-year permit validity period shall submit records
of 20 cases; however, AR Institutions handling less than 20 cases within the
three-year permit validity period shall submit records of all cases.)
a. Personal information of recipient couples, the examination records, the
assessment data (including case indications), the surgical procedures and
results, and the surgery consent form (photocopy)
b. Personal information of donors and recipient couples, the examination
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records, the assessment data, the surgical procedures and results, and the
embryo preservation and destruction conditions (Note 1)
c. Culture medium preparation or quality testing related data
d. Induced ovulation method (including types of ovulation medicine used)
e. Inspection of the aspirated substances of ovarian follicle, and identification
of oocytes
f. Oocyte count and oocyte quality and maturity assessment
g. Sperm preparation (including collection, analysis, washing, and recycling
procedures)
h. Insemination of oocytes and determination of the oocyte fertilization status
i. Incubation and implantation of fertilized oocytes
j. Embryo incubation, status of embryo division, and identification of embryo
grade
k. Embryo implantation (via uterus or Fallopian tubes)
l. Cryopreservation of sperm, oocytes, or embryos
m. Number of pregnancy cases, miscarriages, and number of live births
n. Sex and weight of infant, delivery method, and records of congenital
deformity and other abnormalities.
(2) Control of the operation outcomes
a. Frozen and thawed records of cryopreserved human embryos
b. The live birth rate of cryopreserved human embryos in the last three (3) year
valid period (Notes 2 and 3). Calculation method: The numbers of live birth
cycle of cryopreserved human embryos ÷the numbers of implanted cycle of
cryopreserved human embryos.
c. The cumulative live birth rate of treatment cycles of women less than 38
years old within the last three (3) years of valid period (Notes 2 and 3) .
Calculation method: (the number of live birth cycles of fresh human
embryos + the number of live birth cycles of cryopreserved human
embryos) ÷ the number of treatment cycles
d. Technical experiences and records of intracytoplasmic sperm injection into
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human oocytes
e. The effectiveness and accuracy of artificial reproductive data report during
the current permit period.
(i) The effectiveness of stipulated report forms for artificial reproduction
cases entering into treatment cycle after starting using ovulation drugs and
information list of artificial reproduction cases.
(ii) The effectiveness of stipulated report form of the preservation status of
germ cells or embryos and operation results in the report form of
donations germ cell operation results.
f. The ratio of women under the age of 35 who have been implanted with less
than two embryos.
g. The monitoring, improvement plans and records of moderate and severe
ovarian hyper stimulation syndrome.
h. The monitoring and records of sex ratio at birth.
Notes:
1. Where a medical care institution provides no donation services, the
requirement of “The personal information of donors, the examination
and assessment data, the operational results, the embryo preservation
and destruction conditions” provided in Subparagraph b of Paragraph (1)
“Records of relevant operation procedures” and “The effectiveness of
stipulated report form of the preservation status of germ cells or
embryos and operation results in the report form of donations germ cell
operation results” provided in Subparagraph 5 of Paragraph
2
“Control of the operation outcomes” shall be excluded from the total
score calculation.
2. Statistics of cumulative live birth rate of treatment cycles of
cryopreserved human embryo of women under the age of 38 within the
latest three (3) years of valid period shall be calculated from one year
and three months prior to the expiration of the permit validity period.
3. The following data are established by the competent authority pursuant
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to the “Artificial Reproduction Database” which are statistically scored
within the permit validity period (scores were rounded off to the first
decimal point)
(1) The accumulative cryopreserved human embryos live birth rate of
treatment cycles of women under age 38 in the latest three years of
valid period;
(2) The ratio of women under the age of 35 who have been implanted
with less than two embryos within current permit period.
(3) The effectiveness of stipulated report forms for artificial reproduction
cases entering into a treatment cycle after starting to use ovulation
drugs, and information list of artificial reproduction cases.
(4) The effectiveness of stipulated report form of donations germ cell
operation results.
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Attached Table 4 Artificial reproduction institution permit renewal
review items, standards, and point distribution table
Review Item and
Designated
Standard
Point
1. Regular assessment
8 points
Review Principles
Score
1. An assessment is conducted at 8 points
of the work
least once every three months;
performance of
procedure is duly documented,
employees
and results are reviewed and
analyzed. Active corrective
action has been implemented.
2. An assessment is conducted at 6 points
least once every three months;
procedure is duly documented.
3. Assessment is not conducted at 0 point
least once every three months,
or documented records are
incomplete.
2. Records of laboratory 8 points
Regular maintenance,
1 point will be
equipment
calibration, and records are
deducted for
maintenance and
conducted on laboratory
every missing
repair conducted by
equipment items 3, 4, 5, 6, 10,
item.
assigned personnel
11, 15, and 16 as set forth in the
attached Table 2
3. Laboratory quality
control
84 points
(1) Records of relevant
1. Personal information of
operation
procedures
a. Personal information 6 points
recipient couples
If data of each
record stated in
2. Various examination records
the left column
3. Assessment data (including
is complete, a
of recipient couples,
case indications)
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l.5-point credit
the examination
4. Surgery consent form
is given; a 1-
records, the
point credit is
assessment data
given for
(including case
incomplete
indications), the
records, and no
surgical procedures
point is given
and results, and the
where no
surgery consent form
record is
(photocopy)
available.
b. Personal information 6 points
1. Personal information of
of donors and
If data of each
donors and recipient couples
record stated in
recipient couples, the
2. Various examination records
the left column
examination records,
3. Assessment data (including
is complete, a
the assessment data,
the surgical
case indications)
4. Letter of consent
l.5-point credit
is given; a
procedures and
1-point credit
results, and the
is given for
embryo preservation
incomplete
and destruction
records, and no
conditions (Note 1)
point is given
where no
record is
available.
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c. Culture medium
2 points
Score assessment is based on the Credit point is
preparation or quality
integrity of the records submitted halved if
testing related data
or the presence or absence of
records are
records.
incomplete; no
d. Induced ovulation
4 points
method (including
point is given
types of ovulation
where no
medicine used)
record is
e. Inspection of the
1 point
available.
follicle aspirated
substances and
identification of
oocyte
f. Oocyte count and
1 point
oocyte quality and
maturity assessment
g. Sperm preparation
1 point
(including collection,
analysis, washing, and
recycling procedures)
h. Insemination of
2 points
oocytes and
determination of the
oocyte fertilization
status
i. Incubation and
1 point
implantation of
fertilized oocytes
j. Embryo incubation,
3 points
status of embryo
division, and
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identification of
embryo grade
k. Embryo implantation 1 point
(via uterus or
Fallopian tubes)
l. Cryopreservation of
2 points
sperm, oocytes, or
embryos
m. Number of pregnancy 1 point
cases, miscarriages,
and number of live
births
n. Sex and weight of
2 points
infant, delivery
method, and records
of congenital
deformity and other
abnormalities
(2) Control of the
1. Cryopreservation, thawing,
operation outcomes
a. Records of
4 points
and implantation procedures
4 points
were implemented and duly
cryopreservation and
documented;
thawing of human
2. Cryopreservation procedures
embryos
2 points
were implemented and duly
documented;
3. No cryopreservation records
0 point
documented.
b. Live birth rate of
cryopreserved human
3 points
1. ≧10%
3 points
2. 1%-9%
2 points
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embryos recorded in
3. Successful pregnancy but no 1 point
the last three years or
live birth
current valid period
(Notes 2 and 3).
c. The cumulative live
26 points
1. Above 25％
26 points
birth rate of treatment
2. 20％－24％
23 points
cycles of women less
3. 15％－19％
20 points
than 38 year old
4. 10％-14％
16 points
within the last three
5. 1％-9％
5 points
(3) years of valid
6. 0％
0 point
Surgeries were performed and
2 points
period (Notes 2 and
3).
d. Technical experiences 2 points
and records of
duly documented.
intracytoplasmic
No surgical procedure performed 0 point
sperm injection into
and documented
human oocytes
e. The ratio of women
8 points
1. Above 55％
8 points
under the age of 35
2. 30％-54％
4 points
who have had less
3. 20％-29％
2 points
than two embryos
4. 1％-19％
1 point
implanted within
5. 0
0 point
current permit period
(Note 3).
f. The monitoring,
2 points
1. The monitoring, improvement 2 points
improvement plans
plans and records were carried
and records of
out.
moderate and severe
2. The monitoring was carried
ovarian hyper
out without, improvement
stimulation syndrome.
plans and records.
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1 point
3. No monitoring, improvement 0 point
plans and records were carried
out.
g. The effectiveness
and accuracy of
artificial
reproductive data
reports during the
current permit
period (Note 3)
(i) The effectiveness of 2 points
1. 0-1 overdue data report
2 points
stipulated report
2. 2-4 overdue data reports
1 point
forms for artificial
3. ≧5 overdue data
0 point
1. Report is true or accurate
2 points
reproduction cases
entering into
treatment cycle after
starting to use
ovulation drugs and
information list of
artificial
reproduction cases.
(ii) The effectiveness
of stipulated report
2 points
2. Report is not true or accurate 0 point
form on the
preservation status
of germ cells or
embryos and
operation results in
the report form of
donated germ cell
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operation results.
h. The monitoring and
2 points
1. Having monitored and
records of sex ratio at
2 points
recorded
birth
2. Having not monitored and
0 point
recorded
Total Scores
100 points
Notes:
1. Where a medical care institution provides no donation services, the
requirement of “The personal information of donors, the examination
and assessment data, the operational results, the embryo preservation
and destruction conditions” provided in Subparagraph b of Paragraph (1)
“Records of relevant operation procedures” and “The effectiveness of
stipulated report form of the preservation status of germ cells or
embryos and operation results in the report form of donations germ cell
operation results” provided in Subparagraph 5 of Paragraph 2 “Control
of the operation outcomes” shall be excluded from the total score
calculation.
2. Statistics of cumulative live birth rate of treatment cycles of
cryopreserved human embryo of women under the age of 38 within the
latest three (3) years of valid period shall be calculated from one year
and three months prior to the expiration of the permit validity period.
3. The following data are established by the competent authority pursuant
to the “Artificial Reproduction Database” which are statistically scored
within the permit validity period (scores were rounded off to the first
decimal point)
(1) The live birth rate of cryopreserved human embryos in the last three
(3) year valid period. Calculation method: The number of live birth
cycles of cryopreserved human embryos ÷the number of implanted
20
cycles of cryopreserved human embryos.
(2) The cumulative live birth rate of treatment cycles of women less than
38 years old within the last three (3) years of valid period.
Calculation method: (the number of live birth cycles of fresh human
embryos + the number of live birth cycles of cryopreserved human
embryos) ÷ the number of treatment cycles
(3) The ratio of women under the age of 35 who have had less than two
embryos implanted within the current permit period.
(4) The effectiveness of stipulated report forms for artificial reproduction
cases entering into treatment cycle after starting to use ovulation
drugs and information list of artificial reproduction cases.
(5) The effectiveness of stipulated report form on donated germ cell
operation results.
4. Where an artificial reproduction institution obtains its first and permit
renewal prior to the promulgation and enforcement of the amendment of
these Regulations on February 18 of 2014, its data with respect to e.
“The ratio of women under the age of 35 who have planted less than
two embryos within current permit period”, f. “The monitoring,
improvement plans and records of moderate and severe ovarian hyper
stimulation syndrome”, g. “The effectiveness and accuracy of artificial
reproductive data report during the current permit period” and h. “The
monitoring and records of sex ratio at birth” shall be reviewed from the
date of amendment.
5.Where the scores given to the AR institution on the review items showed
in the attached Table are 85% or higher, said AR institution shall be
regarded as having passed review; those receiving scores of 84% or
below shall be regarded as having failed the review. The on-site
inspection procedure shall be foregone in the subsequent permit renewal
application of AR Institutions that have received a score of 90% or
above in this review.
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Attached Table 5 Facilities and equipment requirements for a
public interest registered society applying to establish a
sperm bank
1. Optical microscope
2. Laminar flow hood
3. Laboratory (sperm inspection, freezing, storage, and
operations)
4. Computerized freezer or equivalent sperm freezing
equipment
5. Liquid nitrogen storage tank, freezing bottle, or freezing
tube
6. Sperm counter
7. Sperm counting plate
8. Dry container for medicine storage
9. Freezer
10. Sink for hand-washing
11. Air conditioning equipment
12. Sperm collection room
13. Sterile sperm collection cups
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