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The first tissue bank of Korea

Hans Biomed Co. Ltd received an approval from the KFDA in 2005 to establish the first tissue bank of Korea.

There were several companies, research centers and universities that were researching artificial organs and tissue technology in Korea. However, Hans Biomed Co. Ltd was the only one to receive an approval to establish the tissue bank. Human tissue transplant materials were being used in medical centers, but there were no set laws regarding the items of use, which led to black trades and other various problems when we obtained the approval to establish the first tissue bank of Korea.

The significance of this is that it enables transparent and safe transfer of human tissue transplant materials through the tissue bank, where Hans Biomed Co. Ltd was at the center of this. We received an approval to build a clean room where the human tissues can be stored in an aseptic environment, with our specialized employees, to contribute to the business of human tissue transplant in Korea.

What is a tissue bank?

This refers to a facility or organization where the human tissues donated by living or deceased donors are collected/stored/processed/stored/distributed. The relevant legal item is the ‘Legislation for the safety and management of human tissues’ that was enacted in January 27, 2005. The main tasks include the collection/storage/processing/preservation/distribution of the tissues, and promotion/consultation/selection of donors and the assurance of tissue quality for the management of donors and tissue donation by the Presidential decree.

Human tissues mean bone, cartilage, fascia, skin, amnion, ligaments, tendons, heart valves, blood vessels and body parts that are collected for transplantation to achieve recovery of human health or prevent disability, which do not form organs. The tissue donor is a person who provides the tissues without payment. The donated tissues are used to treat patients. The permitted recipients are non-profit organizations that deal with business related to medical institutes or bodies. Others include tissue processing companies or tissue importers, but these organizations cannot deal with tissue collection or donation.

The medical institute receives the tissues from the tissue bank, and records the results of tissue transplant in the result document to notify the tissue bank within 1 month of transplantation. The records must be stored for 10 years. Should any communicable disease, infections, malignant cancer metastases, or other serious side effects arise from tissue transplantation, the KFDA must be reported.

Hans Biomed Co. Ltd received an approval from the KFDA in 2005 to establish the first tissue bank of Korea.