Tissue Bank Establishment Permit and Renewal Documents — Human Tissue Import and Processing Businesses, 3-Year Validity

Procedure

1. 1. Decide the tissue bank type and scope of work

   Decide whether to apply as a medical institution, non-profit corporation, tissue processor or tissue importer, and choose which of collection, storage, processing, keeping, distribution and import you will perform and which types of tissue you will handle. Tissue processors and tissue importers may not perform tissue donation or collection.

2. 2. Prepare facilities and equipment by type

   A tissue processor needs a tissue processing room, a diagnostic laboratory, a tissue storage room and a records room, and a tissue importer needs a diagnostic laboratory, a tissue storage room and a records room. Each facility must be separated to prevent cross-contamination, and if microbiological testing is outsourced to a medical institution, the equipment for that testing is not required.

3. 3. Set up staff and a quality management system

   Appoint at least 1 each of a tissue bank head, a medical manager who is a physician or dentist, a tissue handler, a quality manager and an administrative staff member. Establish a quality management system covering operations and facility management, donation and transplant suitability, receipt, release and distribution, nonconforming tissue, recall and disposal, traceability, training and document management, and prepare standard operating procedures.

4. 4. Apply for the establishment permit

   Submit the tissue bank establishment permit application with documents on facilities, equipment and staff, a copy of the medical manager's license, quality management system documents and a business operation plan to the Regional Office of Food and Drug Safety with jurisdiction over the location. The processing period for the application is 60 days, and once approved a tissue bank establishment permit certificate is issued.

5. 5. Import approval, change permit and renewal

   To import tissue, obtain import approval from the Minister of Food and Drug Safety for each tissue and register the exporting country's manufacturer. Changing the name, representative, location, tissue bank head, medical manager, type, scope of work or types of tissue handled requires a change permit. Apply for renewal at least 60 days before the 3-year validity period ends; the Regional Office of Food and Drug Safety must notify you of the renewal procedure at least 90 days before expiry.

Required documents

• Tissue bank establishment permit application (Form No. 1 of the Rules on the Safety of Human Tissue)
• Copy of the corporate establishment permit and articles of incorporation (for a corporation whose main purpose is tissue-related business)
• Documents stating facilities, equipment and staff, and a copy of the medical manager's license
• Documents stating the quality management system (including standard operating procedures)
• Copy of the agreement or contract (if there is a cooperation or contractual relationship with another tissue bank)
• Business operation plan
• For renewal: tissue bank permit renewal application (Form No. 4 of the Rules on the Safety of Human Tissue), original establishment permit certificate, and records of tissue processing or import over the previous 3 years
• Letter of authorization (when submitted by a representative)

Fees

Typically several hundred thousand won to several million won across the industry · We will advise after consultation depending on the tissue bank type (import or processing), the number of tissues handled, the scope of quality management documentation and whether it is a new, change or renewal application. Government fees are separate.

See fees and official charges for this service →

Legal basis and review date

• Act on the Safety and Management of Human Tissue, Article 3
• Act on the Safety and Management of Human Tissue, Article 13
• Act on the Safety and Management of Human Tissue, Article 14
• Act on the Safety and Management of Human Tissue, Article 17
• Act on the Safety and Management of Human Tissue, Article 17-2
• Act on the Safety and Management of Human Tissue, Article 25
• Act on the Safety and Management of Human Tissue, Article 33
• Enforcement Decree of the Act on the Safety and Management of Human Tissue, Article 8
• Enforcement Decree of the Act on the Safety and Management of Human Tissue, Article 9
• Enforcement Decree of the Act on the Safety and Management of Human Tissue, Article 15
• Enforcement Decree of the Act on the Safety and Management of Human Tissue, Annex 1
• Enforcement Decree of the Act on the Safety and Management of Human Tissue, Annex 3
• Rules on the Safety of Human Tissue, Article 5
• Rules on the Safety of Human Tissue, Article 6
• Rules on the Safety of Human Tissue, Article 8
• Rules on the Safety of Human Tissue, Article 16

Checked against the statutes on 2026-10-08

Statutes and public notices change, so each case needs to be checked individually. Statute titles are given in English for reference. The Korean statutes are the authoritative text.

Check these first

• Failing to obtain a renewal permit is subject to an administrative fine, and after the validity period ends you cannot continue operating without a renewal permit. Put the deadline of 60 days before expiry in your schedule.
• If the permitted facilities, equipment, staff or quality management system are no longer maintained, the permit may be cancelled or business suspended for up to 1 year, so recheck staff standards whenever a staff member changes.

Frequently asked questions