ENFORCEMENT DECREE OF THE ACT ON MEDICAL TECHNOLOGISTS
Wholly Amended by Presidential Decree No. 14983, Apr. 19, 1996
Amended by Presidential Decree No. 15598, Dec. 31, 1997
Presidential Decree No. 15886, Sep. 14, 1998
Presidential Decree No. 16426, Jun. 30, 1999
Presidential Decree No. 18312, Mar. 17, 2004
Presidential Decree No. 20679, Feb. 29, 2008
Presidential Decree No. 22075, Mar. 15, 2010
Presidential Decree No. 23296, Nov. 16, 2011
Presidential Decree No. 23488, Jan. 6, 2012
Presidential Decree No. 23759, May 1, 2012
Presidential Decree No. 23802, May 22, 2012
Presidential Decree No. 25738, Nov. 19, 2014
Presidential Decree No. 26130, Mar. 3, 2015
Presidential Decree No. 26742, Dec. 22, 2015
Presidential Decree No. 27633, Nov. 29, 2016
Presidential Decree No. 29383, Dec. 18, 2018
Presidential Decree No. 33112, Dec. 20, 2022
The purpose of this Decree is to provide for matters prescribed by the Act on Medical Technologists and those necessary for the enforcement thereof. [This Article Wholly Amended on May 22, 2012]
| Article 1-2 Deleted. <Dec. 18, 2018> |
| Article 2 (Scope of duties of medical technologists, health information technologists and opticians) |
| (1) | Duties based upon the types of medical technologists under Article 2 (2) of the Medical Service Technologists, etc. Act (hereinafter referred to as the "Act") and the scope of specific duties of medical technologists, health information technologist, and opticians (hereinafter referred to as "medical technologist, etc.") under Article 3 of the Act shall be as specified in Appendix 1. |
| (2) | Medical technologists shall perform the duties provided for in Appendix 1 under the instruction of a physician or dentist. |
[This Article Wholly Amended on May 22, 2012]
| Article 3 (Scope of national examinations) |
| (1) | The national examination referred to in Article 6 of the Act (hereinafter referred to as "national examination") shall be conducted to test the knowledge and skills that each type of medical technologist, etc. must have in the fields of clinical pathology, radiation, physiotherapy, occupational therapy, dental technology, dental hygienics, information management for public health and medical services, optical science, and healthcare-related laws. <Amended on Dec. 18, 2018> |
| (2) | The national examination shall be conducted in a written examination and a practical examination; and only a person who has passed the written examination is eligible for taking the practical examination: provided, both written examination and practical examination may be conducted together if deemed necessary by the Minister of Health and Welfare. |
| (3) | Subjects of the written examination and the scope of the practical examination referred to in paragraph (2), determination of successful candidates, and other necessary matters shall be prescribed by Ministerial Decree of the Health and Welfare. |
[This Article Wholly Amended on May 22, 2012]
| Article 4 (Conducting and publishing national examination) |
| (1) | The Minister of Health and Welfare shall outsource the national examination administration tasks to the Korea Health Personnel Licensing Examination Institute established under the Korea Health Personnel Licensing Examination Institute Act (hereinafter referred to as "managing institute of national examinations") pursuant to Article 6 (2) of the Act. <Amended on Dec. 22, 2015> |
| (2) | To conduct a national examination, the head of the managing institute of national examinations shall publish the date and time, places, and subjects of the national examination; the period for filing applications; and other matters necessary for conducting the examination not later than 90 days prior to the date of the national examination, with the prior approval of the Minister of Health and Welfare: provided, the head of the managing institute of national examinations may publish the places not later than 30 days prior to the date of the national examination after the number of applicants in each region is confirmed. |
[This Article Wholly Amended on May 22, 2012]
The head of the managing institute of national examinations shall appoint examiners whenever he or she conducts a national examination, from among persons with specialized knowledge about each subject of the examination.
[This Article Wholly Amended on May 22, 2012]
| Article 6 (Applying for National Examination) |
Any person who intends to take a national examination, shall file an application in a form prescribed by the head of the managing institute of national examinations with the head of the managing institute of national examinations.
[This Article Wholly Amended on May 22, 2012]
| Article 7 (Issuance of licenses) |
| (1) | Any person who has passed a national examination shall file an application for issuing a license, to be accompanied by documents prescribed by Ministerial Decree of the Health and Welfare, with the Minister of Health and Welfare. |
| (2) | The Minister of Health and Welfare shall issue a license to the person who has filed an application for issuing the license pursuant to paragraph (1), as prescribed by Ministerial Decree of the Health and Welfare. |
[This Article Wholly Amended on May 22, 2012]
| Article 8 (Reporting on status) |
Pursuant to Article 11 (1) of the Act, each medical technologist, etc. shall report his or her status and employment status to the Minister of Health and Welfare by December 31 of every third year after he or she first obtains a license issued under Article 7, as prescribed by Ministerial Decree of the Health and Welfare: provided, a medical technologist, etc. shall file a report by December 31 of every third year, counting from the following prescribed date, if: | 1. | The medical technologist, etc. has a license re-issued after his or her license was revoked pursuant to Article 21 of the Act: The date of re-issuance of the license; |
| 2. | The medical technologist, etc. files a report pursuant to Article 3 (1) of the Addenda to the Act on Medical Technologist (partially amended by Act No. 11102): The date of filing the report. |
[This Article Wholly Amended on Nov. 19, 2014]
| Article 8-2 (Establishment and operation of reporting system) |
| (1) | The following are prescribed as business affairs that can be processed with the electronic information processing system referred to in Article 11 (3) of the Act (hereinafter referred to as "reporting system"): <Amended on Nov. 29, 2016> |
| 1. | The following business affairs in relation to the status and employment status of medical technologists, etc. referred to in Article 11 (1) of the Act: |
| (a) | Receiving reports filed by medical technologists, etc. on their status and employment status, and verifying and managing the data so filed; |
| (b) | Compiling, analyzing, and providing various statistics on the status and employment status of medical technologists, etc.; |
| 2. | Verifying whether medical technologists, etc. have completed refresher training required under Article 20 of the Act, and managing the data on completion of such training; |
| 3. | Other business affairs deemed specifically necessary by the Minister of Health and Welfare in relation to reports on the status and employment status of medical technologists, etc. under Article 11 (1) of the Act. |
| (2) | The Minister of Health and Welfare may request related institutions, corporations, associations, etc. to submit materials or opinions, if deemed necessary to establish and operate the reporting system. <Added on Nov. 29, 2016> |
| (3) | The Minister of Health and Welfare may outsource business affairs concerning the establishment and operation of the reporting system to the managing institute of national examinations. <Amended on Nov. 29, 2016> |
[This Article Added on Nov. 19, 2014]
| Article 9 (Establishment of central association) |
| (1) | A person who intends to establish a central association under Article 16 (1) of the Act (hereinafter referred to as "central association) shall submit the following documents (including electronic documents) to the Minister of Health and Welfare to obtain authorization for establishment: |
| 1. | The articles of incorporation; |
| 3. | A statement of assets; |
| 4. | A resolution of establishment; |
| 5. | Documents concerning the circumstances of election of a founding representative; |
| 6. | Written consents of inauguration and resumes of executive officers. |
| (2) | A central association shall establish branches each in a Special Metropolitan City, Metropolitan Cities, Dos and a Special Self-Governing Province within three weeks from the date of registering its establishment. |
| (3) | The articles of incorporation of a central association shall include the following matters: |
| 4. | Location of the central association, branches, and sub-branches; |
| 5. | Property or accounts and other matters concerning management and operation; |
| 6. | Matters concerning the designation of executive officers; |
| 7. | Matters concerning qualifications for and disciplinary actions against members; |
| 8. | Matters concerning modification of the articles of incorporation; |
| 9. | Matters concerning the method for public announcement; |
| 10. | Matters concerning the operation, etc. of an ethics committee under Article 16 (6) of the Act (hereinafter referred to as "ethics committee"). |
| (4) | Where a central association intends to modify the articles of incorporation, it shall submit the following documents (including electronic documents) to the Minister of Health and Welfare to obtain authorization for modification: |
| 1. | A statement of reasons for modifying the articles of incorporation; |
| 2. | A copy of the minutes of the meetings of a central association concerning the modification of the articles of incorporation; |
| 3. | The articles of incorporation to be amended (including a comparison chart for the new and old articles of incorporation); |
| 4. | Other documents as deemed necessary by the Minister of Health and Welfare. |
| (5) | The business affairs of a central association shall be as follows: |
| 1. | Protection of the rights and interests of medical technologists, etc.; |
| 2. | Information and technology exchange with the relevant domestic and foreign organizations or institutions; |
| 3. | Research and development regarding the business affairs of medical technologists, etc.; |
| 4. | Other business affairs as deemed necessary by the Minister of Health and Welfare. |
[This Article Added on Dec. 18, 2018]
| Article 10 (Organization of ethics committee) |
| (1) | An ethics committee shall be comprised of 11 members, including the chairperson. |
| (2) | Committee members shall be commissioned by the head of each central association from among the following persons considering gender equality, and at least four committee members falling under subparagraph 2 shall be included therein: |
| 1. | Members of a central association who have at least ten years of experience as medical technologists, etc.; |
| 2. | Persons who are not medical technologists, etc. and have abundant experience and knowledge in law, public health, media, the rights and interests of consumers, etc. |
| (3) | The chairperson of an ethics committee shall be commissioned by the head of a central association, from among committee members. |
| (4) | The term of office of a committee member shall be three years and a committee member may be appointed consecutively for only one further term. |
[This Article Added on Dec. 18, 2018]
| Article 10-2 (Operation of ethics committee) |
| (1) | An ethics committee shall deliberate and decide on the following matters: |
| 1. | Matters concerning requests for the suspension of qualification under Article 22-2 of the Act; |
| 2. | Matters concerning examination of qualification for the members of each central association and disciplinary actions against members; |
| 3. | Other matters prescribed by each central association's articles of incorporation as necessary for adherence to a code of ethics by its members. |
| (2) | The meetings of an ethics committee shall be convened by the chairperson of the relevant ethics committee, in cases of paragraph (1) 1 and 2 and where deemed necessary to deliberate and decide on matters under paragraph (1) 3 by the chairperson of the relevant ethics committee or upon request by the head of a central association or at least one-third of committee members. |
| (3) | The chairperson of an ethics committee shall notify each ethics committee member of the date, time, and place of the meeting and items on the agenda by no later than seven days before such meeting is held: provided, where the meeting is required to be urgently held or there is any unavoidable reason, he or she may notify not later than the day before the meeting is held. |
| (4) | Two-thirds of the members of an ethics committee shall constitute a quorum, and any decision thereof shall require the concurring vote of two-thirds of those present: provided, a quorum for a meeting to deliberate and decide on the matters specified in paragraph (1) 2 and 3 may be prescribed by a central association's articles of incorporation. |
| (5) | Where the chairperson of an ethics committee intends to deliberate and decide on any matter referred to in paragraph (1) 1 or 2, he or she shall grant the parties involved in the relevant agenda item with an opportunity to make oral or written statements (including electronic documents). |
| (6) | An ethics committee may organize and operate a specialized advisory group for each field in accordance with the standards determined and publicly notified by the Minister of Health and Welfare, if necessary for the professional review of the matters to be deliberated and decided on under its jurisdiction. |
| (7) | Except as provided in paragraphs (1) through (6), matters necessary for operating an ethics committee or a specialized advisory group for each field under paragraph (6) shall be prescribed by each central association's articles of incorporation. |
[This Article Added on Dec. 18, 2018]
| Article 10-3 (Disqualification of, challenge to, or refrainment by, members) |
| (1) | Any of the following ethics committee members shall be disqualified from deliberations and decisions of the ethics committee: |
| 1. | Where the member, or his or her spouse or ex-spouse is a party to the agenda item subject to deliberations and decisions of the ethics committee (hereafter referred to as "relevant agenda item" in this Article) or is holding any right or duty jointly with the party to such agenda item; |
| 2. | Where the member is or was a relative of a party to the relevant agenda item; |
| 3. | Where the member has given any testimony, statement or advice regarding the relevant agenda item; |
| 4. | Where the member works or worked for an institution to which a party to the relevant agenda item has belonged within the last three years. |
| (2) | If the circumstances indicate that it would be impracticable to expect impartial deliberations and decisions by a member of the ethics committee, any party to the relevant agenda may file a request for a challenge to the member with the ethics committee, which shall make a decision thereon with the attendance of a majority of the committee members and by the concurring vote of a majority of those present. In such cases, the member subject to such request for challenge shall not participate in the resolution. |
| (3) | Where a member of the ethics committee falls under any ground for disqualification under each subparagraph of paragraph (1), he or she shall voluntarily refrain from deliberations and decisions on the relevant agenda item. |
[This Article Added on Dec. 18, 2018]
| Article 10-4 (Dismissal of members) |
Where a member of the ethics committee falls under any of the following cases, the head of a central association may dismiss such member from his or her office:
| 1. | Where he or she becomes incapable of performing his or her duties due to mental or physical disability; |
| 2. | Where he or she engages in misconduct in connection with his or her duties; |
| 3. | Where he or she is deemed unsuitable for a member due to delinquency of duties, injury to dignity, or any other reason; |
| 4. | Where he or she fails to refrain him or her despite falling under any subparagraph of Article 10-3 (1); |
| 5. | Where he or she voluntarily declares that it is impracticable to perform his or her duties. |
[This Article Added on Dec. 18, 2018]
| Article 11 (Refresher training) |
| (1) | The following are prescribed as hours, methods, and curricula of refresher training referred to in Article 20 (1) of the Act (hereinafter referred to as "refresher training"): <Amended on Dec. 18, 2018> |
| 1. | Hours of refresher training: At least eight hours a year; |
| 2. | Methods of refresher training: Face-to-face programs or online programs using an information and communications network; |
| 3. | Curricula of refresher training shall include the following: |
| (a) | Ethics and codes of conduct; |
| (b) | Matters related to improving the expertise and working practices; |
| (c) | Matters related to complying with medicine-related laws; |
| (d) | Other matters similar to those referred to in items (a) through (c), deemed necessary by the Minister of Health and Welfare to be included in refresher training. |
| (2) | With regard to recognition of the training hours referred to in paragraph (1) 1, the Minister of Health and Welfare shall prescribe and notify criteria for the recognition, criteria for the operation and evaluation of training, and other related matters. |
[This Article Added on Nov. 29, 2016]
| Article 12 (Re-issuance of licenses) |
| (1) | The following are prescribed as any ground for re-issuing a license under Article 21 (2) of the Act: |
| 1. | Where a license has been revoked on the grounds provided for in subparagraphs 1 through 3 of Article 5 of the Act: When the grounds for revocation of the license cease to exist; |
| 2. | Where a license has been revoked on the grounds provided for in subparagraph 4 of Article 5 of the Act: When one year has passed since the execution of the sentence imposed on a medical technologist, etc. was completed or remitted and the medical technologist, etc. is deeply remorseful of his or her violation; |
| 3. | Where a license has been revoked on the grounds provided for in Article 21 (1) 3 or 4 of the Act: When one year has passed since the license for a medical technologist, etc. was revoked and the medical technologist, etc. is deeply remorseful of his or her misconduct; |
| 4. | Where a license has been revoked on the grounds provided for in Article 21 (1) 3-2 of the Act: When six months have passed since the license for a medical technologist, etc. was revoked and the medical technologist, etc. is deeply remorseful of his or her misconduct. |
| (2) | Procedures and methods for re-issuing licenses under paragraph (1) and other necessary matters shall be prescribed by Ministerial Decree of the Health and Welfare. |
[This Article Wholly Amended on May 22, 2012]
| Article 13 (Scope of loss of dignity by medical technologists, etc.) |
The following are prescribed as the scope of loss of dignity referred to in Article 22 (1) 1 of the Act: <Amended on Dec. 18, 2018> | 1. | Performing the duties beyond the duties of medical technologists, etc. provided for in Article 2; |
| 2. | Performing the duties provided for in Article 2 without the instruction of a physician or dentist (excluding health information technologist and opticians); |
| 3. | Performing duties in a scientifically or ethically unacceptable manner; |
| 4. | Making a misrepresentation of any laboratory result. |
[This Article Wholly Amended on May 22, 2012]
| Article 14 (Entrustment of duties) |
| (1) | Pursuant to Article 28 (2) of the Act, the Minister of Health and Welfare shall outsource the duties of receiving reports filed under Article 11 (1) of the Act to the associations established based on the types of medical technologist licenses, etc. pursuant to Article 16 of the Act (hereafter referred to in this Act as "central associations"). <Amended on Dec. 18, 2018> |
| (2) | Any central association to which the duties are outsourced under paragraph (1) shall report the results of the outsourcing to the Minister of Health and Welfare, as prescribed by Ministerial Decree of the Health and Welfare. <Amended on Dec. 18, 2018> |
| (3) | Pursuant to Article 28 (2) of the Act, the Minister of Health and Welfare shall outsource refresher training for medical technologists, etc. provided for in Article 20 of the Act to any of the following institutions recognized as capable of conducting such refresher training: <Amended on Dec. 18, 2018> |
| 1. | A junior college or higher-level school that has major courses related to the licenses for medical technologists, etc. among the schools referred to in Article 2 of the Higher Education Act; |
| 2. | A central association; |
| 3. | A research institute related to the duties of medical technologists, etc. |
| (4) | Where the Minister of Health and Welfare outsources refresher training under paragraph (3), he or she shall publish the institutions to which refresher training is outsourced and the duties outsourced. |
[This Article Wholly Amended on Nov. 19, 2014]
| Article 14-2 (Handling of sensitive information and personally identifiable information) |
The Minister of Health and Welfare; a Special Self-Governing City Mayor; a Special Self-Governing Province Governor; the head of a Si/Gun/autonomous Gu (including persons to whom the authority of said persons has been delegated or entrusted, if applicable); or the managing institution of national examinations may handle health-related information referred to in Article 23 of the Personal Information Protection Act; information that constitutes a criminal history record referred to in subparagraph 2 of Article 18 of the Enforcement Decree of said Act; or data that contains a resident registration number or an alien registration number referred to in subparagraph 1 or 4 of Article 19 of the Enforcement Decree of said Act, if essential to performing the following duties: <Amended on Nov. 19, 2014; Presidential Decree No. 26130, Mar. 3, 2015> | 1. | Administering national examinations under Article 6 of the Act; |
| 2. | Verifying eligibility to apply for national examinations under Article 7 of the Act; |
| 3. | Registering licenses of medical technologists, etc. and issuing licenses under Article 8 of the Act; |
| 3-2. | Deleted; <Dec. 20, 2022> |
| 4. | Deleted; <Dec. 20, 2022> |
| 5. | Deleted; <Dec. 20, 2022> |
| 6. | Deleted; <Dec. 20, 2022> |
| 7. | Issuing administrative dispositions under Articles 21 through 26 of the Act; |
| 8. | Re-issuing licenses under Article 12 of the Act. |
[This Article Wholly Amended on May 22, 2012]
| Article 15 (Criteria for imposing administrative fines) |
Criteria for imposing administrative fines provided for in Article 33 (1) and (2) of the Act are as specified in Appendix 2. <Amended on Nov. 29, 2016; Dec. 18, 2018> [This Article Wholly Amended on Nov. 16, 2011]
ADDENDA <Presidential Decree No. 14983, Apr. 19, 1996>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation.
Article 2 (Partial exemption, etc. from written examination for persons eligible for transitional measures concerning national examinations for opticians)
| (1) | Any person who has at least five years' experience in making and selling glasses as of May 28, 1998, among those eligible to apply for the national examination for opticians pursuant to Article 4 of the Addenda to the Medical Service Technologists Act (amended by Act No. 3949) shall be exempt from a written examination conducted pursuant to Article 3 (2) of this Decree. |
| (2) | Any person who intends to be exempt from a written examination under paragraph (1) shall file an application, to be accompanied by a written confirmation issued by the head of the public health clinic having jurisdiction over the place of his or her eyeglass shop. |
| (3) | Any person who has passed a practical examination among those who have been exempt from a written examination under paragraph (1) shall be issued a license upon completing in-service training for a prescribed period, as prescribed by Ministerial Decree of the Health and Welfare. |
Article 3 (Duties of persons engaged in practice of physiological tests)
Any person who has passed the national examination for clinical laboratory technoloists pursuant to Article 7 (2) of the Addenda to the Act shall conduct physiological tests (referring to electrocardiogram, electroencephalograph, and tests of cardiopulmonary functions, base metabolism, and other physiological functions); and manage equipment necessary for physiological tests and accessories and supplies for such equipment.
ADDENDUM <Presidential Decree No. 15598, Dec. 31, 1997>
This Decree shall enter into force on January 1, 1998.
ADDENDUM <Presidential Decree No. 15886, Sep. 14, 1998>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 16426, Jun. 30, 1999>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 18312, Mar. 17, 2004>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 20679, Feb. 29, 2008>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 22075, Mar. 15, 2010>
Article 1 (Enforcement date)
This Decree shall enter into force on March 19, 2010. (Proviso Omitted.)
ADDENDA <Presidential Decree No. 23296, Nov. 16, 2011>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation: provided, the amended provisions of the former part of Article 2 (1) 6 shall enter into force one year and six months after the date of its promulgation. Article 2 (Transitional measures concerning administrative fines)
Criteria for imposing administrative fines for any violation committed before this Decree enters into force, shall be governed by the former provisions, notwithstanding the amended Appendix.
ADDENDA <Presidential Decree No. 23488, Jan. 6, 2012>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
ADDENDA <Presidential Decree No. 23759, May 1, 2012>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
Article 2 (Applicability to public notice of examination)
The provision of this Decree that amends the deadline for publishing examinations, etc., shall begin to apply from the examinations conducted on or after January 1, 2013.
ADDENDUM <Presidential Decree No. 23802, May 22, 2012>
This Decree shall enter into force on May 23, 2012: provided, the amended provisions of the former part of Article 2 (1) 6 shall enter into force on May 17, 2013.
ADDENDUM <Presidential Decree No. 25738, Nov. 19, 2014>
This Decree shall enter into force on November 23, 2014.
ADDENDA <Presidential Decree No. 26130, Mar. 3, 2015>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation.
Article 2 (Transitional measures concerning administrative fines)
| (1) | Guidelines for imposing administrative fines for any violation committed before this Decree enters into force shall be governed by the former provisions, notwithstanding the amended Appendix. |
| (2) | An administrative fine imposed for a violation committed before this Decree enters into force shall be disregarded for the purposes of counting the number of violations provided for in the amended Appendix. |
ADDENDA <Presidential Decree No. 26742, Dec. 22, 2015>
Article 1 (Enforcement date)
This Decree shall enter into force on December 23, 2015.
ADDENDA <Presidential Decree No. 27633, Nov. 29, 2016>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation: provided, the amended provisions of Article 11 shall enter into force on November 30, 2016. Article 2 (Special cases concerning refresher training)
| (1) | Notwithstanding the amended proviso to Article 11 (1) 1, a person who intends to resume practice as a medical technologist, etc. after having not practiced for at least one year shall undergo the first refresher training for at least eight hours until December 31, 2016. |
| (2) | Notwithstanding the amended provisions of Article 11 (2), recognition of hours of refresher training that medical technologists, etc. have completed shall be as provided for by the head of an institution to which such refresher training is outsourced under Article 14 (3) until December 31, 2016. |
ADDENDA <Presidential Decree No. 29383, Dec. 18, 2018>
Article 1 (Enforcement date)
This Decree shall enter into force on December 20, 2018.
ADDENDUM <Presidential Decree No. 29950, Jul. 2, 2019>
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
ADDENDUM <Presidential Decree No. 33112, Dec. 20, 2022>
This Decree shall enter into force on the date of its promulgation.