Article 8
An organ bank shall prepare the following documents and retain them along with the human organ it preserves:
1. A letter of consent from the donor, except for one of the following circumstances:
(1) In case of an organ transfer, a permit certificate from the recovery organ bank has been presented.
(2) In case of an imported organ, a donor consent certificate from the source institution has been presented.
2. A eligibility certificate of the donor.
3. In case of an imported organ, a document to prove its approval of importation.
4. A report for the result of tests and other necessary processing prescribed in the preceding article.
5. A description or record on the preservation status of the human organ.
Where a human organ is transferred to another organ bank, a copy of the documents mentioned in the preceding paragraph shall be transferred concurrently.
An organ bank shall retain the documents mentioned in the preceding paragraph 1 and 2, for at least another ten (10) years after the human organ concerned has been destroyed or if there is no leftover or derivative of the human organ being preserved after its use.
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Article 11
The central health authority will issue a three-year permit to an organ bank that has passed the onsite inspection.
The permit mentioned in the preceding paragraph shall contain the following information:
1. Name and address of the institution.
2. The representative or responsible person of the institution.
3. The type of organ bank.
4. The location of the organ bank.
5. The names of medical director and quality director.
When there is change to the item mentioned in subparagraph 1, 2 or 5 of the preceding paragraph, an institution shall, within thirty (30) days after the occurrence of fact, apply for change of registration; when there is change to the item mentioned in subparagraph 3 or 4 of the preceding paragraph, an institution shall reapply for approval.
An institution may, within three (3) months before the current permit for its organ bank expires, apply to the central health authority for extension of permit. An institution that has passed the review will receive a permit extension of up to three (3) years.
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Article 14
The central competent health authority may conduct examination of the organ bank of an institution and review relevant records and documents, to which, the institution and its personnel shall not evade, interfere or refuse.
In the case of the necessity to examine an organ bank set up in a foreign country, the central competent health authority may require cooperation of inspection from the institution that store human organs in a foreign organ bank to provide the related documents of import source. The required documents shall apply mutatis mutandis to the rules of sub-paragraphs of Article 9.
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Article 19
When an institution apply for permit of establishment, changes, and extension of an organ bank or to examine an organ bank set up in a foreign country, a fees shall be charged for the application; The charge item and fees shall apply to rules of the Fee-charging Standards for Human Organ Bank Review.
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