ENFORCEMENT DECREE OF THE SAFETY AND MANAGEMENT OF HUMAN TISSUE ACT
Wholly Amended by Presidential Decree No. 26062, Jan. 28, 2015
Amended by Presidential Decree No. 26823, Dec. 30, 2015
Presidential Decree No. 26844, Dec. 31, 2015
Presidential Decree No. 27126, May 3, 2016
Presidential Decree No. 27949, Mar. 20, 2017
Presidential Decree No. 29054, Jul. 17, 2018
Presidential Decree No. 29812, jun. 4, 2019
Presidential Decree No. 31380, Jan. 5, 2021
Presidential Decree No. 31944, Aug. 10, 2021
Presidential Decree No. 33670, Aug. 16, 2023
| Article 2 (Definition of Human Tissue) |
| Article 3 (Organization of Human Tissue Safety and Management Advisory Committee) |
| (1) | A Human Tissue Safety and Management Advisory Committee (hereinafter referred to as the "Committee") referred to in Article 6 (1) of the Act shall be comprised of not more than 15 members, including a chairperson and a vice-chairperson. |
| (2) | The chairperson (hereinafter referred to as the “chairperson”) and the vice-chairperson of the Committee shall be elected from among Committee members. |
| (3) | The Committee members shall be the following persons: |
| 1. | A person designated by the head of the affiliated organization, from among general public officials of Grade III public officials or belong to the Senior Executive Service of the Ministry of Health and Welfare and the Ministry of Food and Drug Safety who are in charge of duties regarding human tissue (hereinafter referred to as “tissue”); |
| 2. | A person designated by the Minister of Health and Welfare from among persons who have broad knowledge and experience on donation, management and transplant of tissues. |
| (4) | The term of the members referred to in paragraph (3) 2 shall be two years. |
| Article 3-2 (Dismissal of Members of Committee) |
Where a member referred to in Article 3 (3) 2 falls under any of the following cases, the Minister of Health and Welfare may dismiss such member: | 1. | If the member is unable to perform any of his or her duties due to a mental or physical disorder; |
| 2. | If the member commits any misdeed relevant to any of his or her duties; |
| 3. | If the member is found incompetent on the ground of his or her neglecting a duty, loss of dignity, or on any other ground; |
| 4. | If a member expresses that it is difficult to perform his or her duties. |
[This Article Newly Inserted on Dec. 31, 2015]
| Article 4 (Operation of Committee) |
| (1) | The chairperson shall represent the Committee and exercise overall control over duties of the Committee. |
| (2) | The chairperson shall convene and chair Committee meetings. |
| (3) | Where the chairperson is unable to perform his or her duties due to extenuating circumstances, the vice-chairperson shall perform such duties on behalf of the chairperson. |
| (4) | In principle, meetings of the Committee shall be held at least annually Provided, That where upon request by the Minister of Health and Welfare or majority of the Committee members or where the chairperson deems necessary, the chairperson shall convene a meeting. |
| (5) | A majority of the members of the Committee shall constitute a quorum, and any decision thereof shall require the concurring vote of a majority of those present. |
| (6) | To handle the duties of the Committee, the Committee shall have one secretary, designated by the Minister of Health and Welfare from among the public officials belonging to the Ministry of Health and Welfare. |
| (7) | Except as provided in paragraphs (1) through (6), matters necessary for the operation of the Committee shall be determined by the chairperson after resolution by the Committee. |
| Article 5 (Duties of National Tissue Donation Management Agency) |
| 1. | Education and consultation regarding tissue donation; |
| 2. | Duties regarding the promotion for spreading tissue donation culture; |
| 3. | Other duties deemed necessary by the Minister of Health and Welfare for properly managing tissue donations by the National Tissue Donation Management Agency referred to in Article 6-2 of the Act (hereinafter referred to as the “National Tissue Donation Management Agency”). |
| Article 6 (Standard for Designation of Tissue Donation Registry) |
A person who intends to be designated as a tissue donation registry pursuant to Article 7-3 (1) of the Act (hereinafter referred to as “registry”) shall prepare the following facilities, human resources and equipment: | 3. | Computation equipment necessary for the receipt, registration and notification of completed registration of tissue donors and candidates for tissue donation pursuant to Article 7-3 (3) 1 and 2 of the Act. |
| Article 7 (Priority Order for Distributing Tissues) |
| 1. | Recovered tissues shall be distributed in priority to medical institutions which urgently required to transplant tissues for the treatment of patients; |
| 2. | Tissues other than those distributed pursuant to subparagraph 1 shall be distributed to tissue banks or medical institutions that perform tissue transplantation (hereinafter referred to as "tissue transplant hospital"), in light of the purpose of transplantation, treatment effects, suitability of transplantation, etc. |
| (2) | The detailed standards of the priority order for distributing tissues pursuant to paragraph (1) shall be determined and publicly notified by the Minister of Health and Welfare. |
| (3) | The head of a tissue bank which distributes tissues pursuant to paragraph (1) shall report the result, etc. of tissue distribution to the head of the National Tissue Donation Management Agency, as prescribed by the Minister of Health and Welfare. |
| Article 8 (Permission Standards for Tissue Banks) |
The standards of facilities, equipment, and human resources, quality control system, etc. which shall be equipped by a person who intends to establish a tissue bank under Article 13 (1) of the Act shall be as provided for in attached Table 1.
| Article 9 (Renewal of Permission for Tissue Banks) |
| (1) | A tissue bank which intends to obtain renewal of permission pursuant to Article 14 (2) of the Act shall submit to the Minister of Food and Drug Safety, an application for renewal of permission for a tissue bank (including electronic documents) by not later than 60 days before the expiration date of the permission attaching the following documents (including electronic documents), as prescribed by Ordinance of the Prime Minister: <Amended on Jun. 4, 2019> |
| 1. | The original permit for the establishment of the tissue bank; |
| 2. | Documents regarding the status of facilities, equipment, and human resources, quality control system, etc. of the tissue bank; |
| 3. | Documents regarding the performance record of tissue processing or import for the previous three years. |
| (2) | Upon receipt of an application for renewal of permission for a tissue bank pursuant to paragraph (1), the Minister of Food and Drug Safety shall verify whether the standards of facilities, equipment, and human resources, quality control system, etc. of the relevant tissue bank meet the standards prescribed in attached Table 1 and the performance record of recovering, storing, processing, importing, preserving, or distributing tissues for the previous three years, and when he or she deems it necessary to renew the permission, he or she shall issue a permit for the establishment of the tissue bank, as prescribed by Ordinance of the Prime Minister. <Amended on Jun. 4, 2019> |
| Article 10 (Designation Standards for Tissue Donation Support Institutions) |
The facilities, equipment and human resources which a person who intends to be designated as a tissue support institution pursuant to Article 16-2 (4) of the Act (hereinafter referred to as “tissue support institution”) shall be equipped with shall be as provided for in attached Table 2.
| Article 11 (Subjects for Duties of Confidentiality) |
“Persons prescribed by Presidential Decree” in the provision, with the exception of the subparagraphs, of Article 22 (1) of the Act means any of the following persons: | 1. | The head of the National Tissue Donation Management Agency and a person who conducts the duties referred to in Article 6-2 (2) of the Act in the National Tissue Donation Management Agency; |
| 2. | The head of a registry and a person who conducts the duties referred to in Article 7-3 (3) of the Act in the registry (including the head of an organ transplantation registry conducting the duties of the registries pursuant to paragraph (4) 1 of the same Article and persons conducting such duties); |
| 5. | Any of the following persons, who works in a tissue transplant hospital: |
| (a) | A physician or dentist who conducts tissue transplantation, and other persons who participates in transplantation surgery; |
| (b) | A person who keeps or manages the record regarding tissue transplantation; |
| (c) | A person who participates in the physical examination of a person who intends to be subject to the tissue transplantation; |
| 6. | A person who works in a medical institution, etc. which is consigned a blood test, etc. from a tissue bank, and participates in a blood test, etc. of a tissue donor, etc.; |
| 7. | A person who participates in the establishment, management, operation of a computer network system that manages information on the donation, management, transplantation, etc. of tissues pursuant to Article 27 (3) of the Act; |
| 8. | Other persons determined and publicly announced by the Minister of Health and Welfare or the Minister of Food and Drug Safety, who participates in the duties regarding the donation, management and transplantation, etc. of tissues. |
| Article 12 (Investigation of Registries) |
An investigation referred to in Article 23 (2) of the Act shall be conducted by the following inspection and verification against registries, tissue donation support institutions, tissue banks and tissue transplant hospitals: | 1. | Inspection and verification of details of the records which are to be maintained according to the Act; |
| 2. | Inspection of storage, management status, etc. of tissues; |
| 3. | Verification of qualifications of the facilities and equipment, etc. of registries, tissue donation support institutions, and tissue banks; |
| 4. | Inspection of matters deemed necessary by the Minister of Health and Welfare or the Minister of Food and Drug Safety regarding donation, management, transplantation, etc. of tissues. |
| Article 13 (Transfer and Submission of Data) |
| (1) | The head of a tissue bank shall transfer or submit records or data to the Minister of Food and Drug Safety pursuant to Article 26 (3) of the Act, within the following relevant period: <Amended on Jun. 4, 2019> |
| (a) | Records under Article 20 of the Act and data on the results of processing tissues: Within one month from the date the permission is revoked; |
| (b) | Data on plans for processing tissues: Within seven days from the date the permission is revoked; |
| (a) | Records under Article 20 of the Act and data on the results of processing tissues: Within one month from the date the operation of business is ceased; |
| (b) | Data on plans for processing tissues: Not later than seven days before the date the operation of business is to be ceased. |
| (2) | The head of a registry or tissue donation support institution which intends to cease the operation of its business or cease to perform duties or whose designation is revoked under Article 26 (4) of the Act shall transfer the data regarding the implementation of duties pursuant to Article 7-3 (3) or Article 16-2 (1) of the Act to the Minister of Health and Welfare, within the following relevant period: |
| 1. | Where the institution ceases the operation of its business or ceases performing duties pursuant to Article 26 (2) of the Act: Within one month from the date it ceases the operation of its business or cease performing duties; |
| 2. | Where the designation of the institution is revoked pursuant to Article 25 of the Act: Within one month from the date the designation is revoked. |
[Title Amended on Jun. 4, 2019]
| Article 14 (Establishment and Management of Computer Network System) |
| (1) | The Minister of Health and Welfare shall establish, operate and manage a computer network system pursuant to Article 27 (3) of the Act to conduct the following duties: |
| 3. | Investigation and research on tissue donation and preparation of information and statistics thereof; |
| 4. | Computerization of other information on tissue donation and management of tissue distribution. |
| (2) | The Minister of Food and Drug Safety shall establish, operate and manage a computer network system pursuant to Article 27 (3) of the Act to conduct the following duties: <Amended on Jun. 4, 2019> |
| 2. | Computerization of the duties of reporting and management regarding destruction of tissues pursuant to Article 10 (5) of the Act; |
| 3. | Computerization of the duties of reporting and management regarding donation, management and transplant of tissues pursuant to Article 19 (1) of the Act; |
| 4. | Computerization of the duties of reporting and management regarding the findings, side effects, etc. discovered in follow-up inspection pursuant to Article 19 (3) of the Act; |
| 5. | Production, analysis and provision of statistics regarding donation, management and transplant of tissues; |
| 6. | Computerization of other information on tissue banks and safety management of tissues. |
| (3) | The Minister of Health and Welfare and the Minister of Food and Drug Safety shall mutually cooperate in using the computer network systems and information sharing pursuant to paragraphs (1) and (2). |
| Article 15 (Delegation of Authority) |
The Minister of Food and Drug Safety shall delegate the following authority to the head of a Regional Office of Food and Drug Safety pursuant to Article 28 of the Act: | 3. | Permission for renewal granted to a tissue bank and notification of permission under Article 14 of the Act; |
| 6. | Ordering a tissue bank or tissue transplant hospital to suspend the use of tissues, collect or destroy tissues, or take necessary measures, and instructing relevant public officials to destroy tissues or impose necessary dispositions under Article 24-2 of the Act; |
| 10. | Imposing and collecting administrative fines on and from a tissue bank and its employees under Article 37 (2) of the Act. |
[This Article Wholly Amended on Aug. 10, 2021]
| Article 16 (Management of Sensitive Information and Personally Identifiable Information) |
| 1. | Affairs regarding the management of completed registration of tissue donors notified by a registry pursuant to Article 7-3 (3) 1 of the Act; |
| 4. | Affairs regarding the management of data transferred by the head of a tissue bank, a registry and a tissue donation support institution pursuant to Article 26 (3) and (4) of the Act; |
| 5. | Affairs regarding the request to provide data on the medical history and the record of administered medicines of tissue donors pursuant to Article 29 (3) of the Act. |
| (2) | The head of the National Tissue Donation Management Agency may manage health information, etc. and data including resident registration numbers, if it is essential to conduct the following affairs: |
| 1. | Affairs regarding the registration and management of tissue donors and candidates for tissue donation pursuant to Article 6-2 (2) 1 of the Act; |
| 2. | Affairs regarding the decision of registration and notification, etc. of tissue donors and candidates for tissue donation pursuant to Article 7-2 (2) of the Act; |
| 3. | Affairs regarding the management of completed registration of tissue donors notified by a registry pursuant to Article 7-3 (3) 1 of the Act. |
| (3) | The head of a tissue bank may manage health information, etc. and data including resident registration numbers, if it is essential to conduct the following affairs: <Amended on Jun. 4, 2019> |
| 3. | Affairs regarding the request to inspect the medical history and the record of administered medicines of tissue donors pursuant to Article 10 (3) of the Act; |
| 4. | Affairs regarding the management of the results of tissue transplant notified pursuant to the former part of Article 19 (2) of the Act; |
| 5. | Affairs regarding the request to inspect the medical history and the record of administered medicines of tissue donors pursuant to Article 29 (2) of the Act. |
| (4) | The head of a registry may manage health information, etc. and data including resident registration numbers, if it is essential to conduct the following affairs: |
| 2. | Affairs regarding the receipt, registration and notification of completed registration of tissue donors and candidates for tissue donation pursuant to Article 7-3 (3) 1 and 2 of the Act. |
| (5) | The head of a tissue donation support institution may manage health information, etc. and data including resident registration numbers, if it is essential to conduct the following affairs: |
| 3. | Affairs regarding the request to inspect the medical history and record of administered medicines of tissue donors pursuant to Article 16-2 (5) of the Act. |
| Article 17 (Re-Examination of Regulation) |
| (1) | The Minister of Health and Welfare and the Minister of Food and Drug Safety shall examine the standards for imposing administrative fines pursuant to Article 18 and attached Table 3 on a three-yearly basis (referring to a period until January 1 of the base date of the year by every third anniversary) based on January 1, 2015, and take measures, such as improvements. <Amended on Dec. 30, 2015> |
| (2) | The Minister of Food and Drug Safety shall examine the appropriateness of the renewal of authorization of a tissue bank pursuant to Article 9 on a three-yearly basis (referring to a period until January 1 of the base date of the year by every third anniversary) based on January 1, 2016, and take measures, such as improvements. <Newly Inserted on Dec. 30, 2015> |
| Article 18 (Criteria for Imposition of Administrative Fines) |
Criteria for imposition of administrative fines under Article 37 of the Act shall be as listed in attached Table 3.
ADDENDA <Presidential Decree No. 26062, Jan. 28, 2015>
Article 1 (Enforcement Date)
This Decree shall enter into force on January 29, 2015.
Article 2 (Relation with Other Statutes and Regulations)
Any citation of the previous Enforcement Decree of the Safety and Management of Human Tissue Act or of any provision thereof, in any other statute or regulation as at the time this Decree enters into force, shall be deemed a citation of this Decree or of the relevant provision of this Decree in lieu of the previous provision, if such relevant provisions exist herein.
ADDENDUM <Presidential Decree No. 26823, Dec. 30, 2015>
This Decree shall enter into force on January 1, 2016.
ADDENDUM <Presidential Decree No. 26844, Dec. 31, 2015>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 27126, May 3, 2016>
This Decree shall enter into force on May 5, 2016.
ADDENDUM <Presidential Decree No. 27949, Mar. 20, 2017>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 29054, Jul. 17, 2018>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 29812, Jun. 4, 2019>
Article 1 (Enforcement Date)
This Decree shall enter into force on December 12, 2019: Provided, That the amended provisions of subparagraph 1 of attached Table 3 and subparagraph 2 (a) of the same Table shall enter into force on June 12, 2019.
Article 2 (Transitional Measures concerning Transfer of Data)
Notwithstanding the amended provisions of Article 13 (1), the previous provisions shall apply where permission for a tissue bank is revoked or the cessation of the business operation of the tissue bank is reported before this Decree enters into force. Article 3 (Transitional Measures concerning Criteria of Imposition of Administrative Fines)
Notwithstanding the amended provisions of attached Table 3, the previous provisions shall apply to violations committed before the enforcement date under the proviso of Article 1 of the Addenda in application of the criteria for the imposition of administrative fines.
ADDENDUM <Presidential Decree No. 31380, Jan. 5, 2021>
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
ADDENDUM <Presidential Decree No. 31944, Aug. 10, 2021>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 33670, Aug. 16, 2023>
This Decree shall enter into force on the date of its promulgation.