KRTA

Article 1 (Purpose)

The purpose of this Decree is to provide for matters prescribed by the Medical Technologists, etc. Act and those necessary for the enforcement thereof.

[This Article Wholly Amended by Presidential Decree No. 23802, May 22, 2012]

Article 1-2 (Duties of Medical Technicians by Type)

“Duties prescribed by Presidential Decree” in Article 2 (2) of the Medical Technologists, etc. Act (hereinafter referred to as the “Act”) shall be as follows:

1. Medical laboratory technicians: The following duties related to various chemical or physiological tests:

(a) Duties related to keeping, managing, and using laboratory equipment, instruments, reagents, etc.;

(b) Duties related to collecting and testing clinical materials, etc.;

(c) Other duties related to medical laboratory tests, such as collecting and preparing blood and preparing reagents for clinical tests;

2. Physical therapists: Such duties as using and managing equipment, drugs, and medical supplies, related to physiotherapy treatments for body correction and rehabilitation;

3. Occupational therapists: Such duties as analyzing and assessing patients’ task performance in relation with occupational therapies to help the patients recover from physical or mental functional disorders;

4. Dental hygienists: Duties related to diagnostic radiography for mouth performed within a healthcare institution or medical institution, conducted for preventing teeth and dental diseases, controlling dental hygiene, and other related purposes.

[This Article Newly Inserted by Presidential Decree No. 27633, Nov. 29, 2016]

Article 2 (Scope, etc. of Duties Performed by Medical Technologists, Health Record Administrators, and Opticians) (1) The following are prescribed as the scope and limit of the duties performed by medical technologists, health record administrators, and opticians referred to in Article 3 of the Act (hereinafter referred to as “medical technologist, etc.”):  <Amended by Presidential Decree No. 26130, Mar. 3, 2015; Presidential Decree No. 27633, Nov. 29, 2016>

1. Medical laboratory technologists: The following duties required for conducting medical laboratory tests in the fields of pathology, microbiology, physiological chemistry, parasitology, hematology, serology, forensic medicine, urine chemistry, and cytopathology; and for conducting tests and physiological tests (referring to electrocardiogram, electroencephalograph, and tests of cardiopulmonary functions, base metabolism, and other physiological functions) of clinical materials, etc. using the radioactive isotopes:

(a) Keeping, managing, and using laboratory equipment, instruments, reagents, etc.;

(b) Collecting and testing clinical materials, etc.;

(c) Preparing reagents for clinical tests;

(d) Collecting, preparing, processing, separating, storing, and supplying blood;

(e) Other duties related to the medical laboratory tests;

2. Radiological technologists: Handling ionizing radiation and unionizing radiation; conducting nuclear medicine examinations using the radioactive isotopes; handling medical imaging equipment and ultrasonic diagnostic equipment; and selecting and managing radiographic equipment and accessory devices and supplies;

3. Physical therapists: Conducting hyperthermia, electrotherapy, light therapy, hydrotherapy, and therapy using equipment and devices; administering massage, functional training, body correctional exercises, and rehabilitation training; using and managing instruments and medication necessary therefor; and performing other physiotherapy treatments;

4. Occupational therapists: Conducting sensory and activity training, occupational training for daily activities, rehabilitation treatments of cognitive impairment, and rehabilitation treatment of dysphagia utilizing objects or tools used in patients’ daily life to ensure smooth recovery from physical and mental functional disorders; manufacturing upper limb prostheses and training the patients to use them; analyzing and assessing the patients’ task performance; and conducting other occupational therapeutic training and treatments;

5. Dental technicians: Making, repairing, or fabricating dental devices necessary for dentists to treat patients, including dental molds, dental prostheses (including aesthetic prostheses and maxillofacial prostheses), customized implant abutments and crowns, inlays and onlays, and orthodontic appliances; and performing other duties of dental technicians;

6. Dental hygienists: Removing plaque and deposits; applying fluorides; placing temporary filling and fixtures; removing the temporary fixtures; making impressions of the teeth; placing and removing orthodontic braces and wires; and performing other duties required for preventing teeth and oral diseases and teeth and oral hygiene. In this regard, the dental hygienists may expose and process dental x-rays within a healthcare institution or medical institution equipped with a diagnostic radiation generator in compliance with the safety control standards referred to in Article 37 (1) of the Medical Service Act;

7. Health record administrators: Classifying records on diseases and operations at medical institutions; analyzing medical records; collecting and compiling statistics on medical records; registering cancer patients; and maintaining and verifying various health-related documentation and records, including transcription;

8. Opticians: Dispensing and selling glasses (limited to those for the correction of a person’s vision; hereinafter the same shall apply); selling contact lenses (including those used not for the correction of a person’s vision; hereinafter the same shall apply). In this regard, the options may conduct eye examinations to verify the correct prescription in a pair of eyeglasses or contact lenses (excluding the eye examination conducted using drugs and objective eye refraction tests conducted without using an automated refractor): Provided, That dispensing and selling glasses and selling contact lenses to children aged six or under requires a doctor’s prescription.

(2) Medical technologists shall perform the duties provided for in paragraph (1) under the instruction of a doctor or dentist.

[This Article Wholly Amended by Presidential Decree No. 23802, May 22, 2012]

Article 3 (Scope of National Examination) (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 qualifications that each type of medical technologist, etc. must have in such subject areas as clinical pathology, radiation, physiotherapy, occupational therapy, dental technology, dental hygienics, health records, optical science, and healthcare-related laws.

(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, That such 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 applicants, and other necessary matters shall be prescribed by Ordinance of the Ministry of Health and Welfare.

[This Article Wholly Amended by Presidential Decree No. 23802, May 22, 2012]

Article 4 (Conducting and Giving Public Notice of National Examination) (1) The Minister of Health and Welfare shall require 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”) to manage national examinations pursuant to Article 6 (2) of the Act.  <Amended by Presidential Decree No. 26742, Dec. 22, 2015>

(2) To conduct a national examination, the head of the managing institute of national examinations shall give a public notice of the date, time, venues, and subjects of the national examination; the period for filing applications; and other matters necessary for conducting the examination by 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, That the head of the managing institute of national examinations may give a public notice of the venues by 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 by Presidential Decree No. 23802, May 22, 2012]

Article 5 (Examiners)

The head of the managing institute of national examinations shall appoint examiners every time he/she conducts a national examination, from among persons with specialized knowledge about each subject of the examination.

[This Article Wholly Amended by Presidential Decree No. 23802, May 22, 2012]

Article 6 (Applying for National Examination)

A person who intends to take a national examination shall file an application 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 by Presidential Decree No. 23802, May 22, 2012]

Article 7 (Issuance of Licenses) (1) A person who has passed a national examination shall file an application for the issuance of a license, to be accompanied by documents prescribed by Ordinance of the Ministry of 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 the issuance of a license pursuant to paragraph (1), as prescribed by Ordinance of the Ministry of Health and Welfare.

[This Article Wholly Amended by Presidential Decree No. 23802, May 22, 2012]

Article 8 (Reporting on Status, etc.)

Pursuant to Article 11 (1) of the Act, every medical technologist, etc. shall report his/her status and employment status with the Minister of Health and Welfare by December 31 of every third year after he/she first obtains a license issued under Article 7, as prescribed by Ordinance of the Ministry of Health and Welfare: Provided, That 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 been re-issued a license after his/her license was revoked pursuant to Article 21 of the Act: The date of re-issuance of the license;

2. The medical technologist, etc. has filed a report pursuant to Article 3 (1) of the Addenda to the Medical Technologists, etc. Act (partially amended by Act No. 11102): The date of filing the report.

[This Article Wholly Amended by Presidential Decree No. 25738, Nov. 19, 2014]

Article 8-2 (Establishment and Operation of Reporting System) (1) The following are the 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 by Presidential Decree No. 27633, 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 the 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 filing reports on the status and employment status by 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 present materials or opinions, if deemed necessary to establish and operate the reporting system.  <Newly Inserted by Presidential Decree No. 27633, Nov. 29, 2016>

(3) The Minister of Health and Welfare may require the managing institute of national examinations to perform the business affairs relating to the establishment and operation of the reporting system.

[This Article Newly Inserted by Presidential Decree No. 25738, Nov. 19, 2014]

Article 9 Deleted.  <by Presidential Decree No. 16426, Jun. 30, 1999>

Article 10 Deleted.  <by Presidential Decree No. 16426, Jun. 30, 1999>

Article 11 (Refresher Training) (1) The following are prescribed as hours, methods, and content of the refresher training referred to in Article 20 (1) of the Act (hereinafter referred to as “refresher training”):

1. Hours of the refresher training (referring to the training hours recognized by the Minister of Health and Welfare): At least eight hours a year: Provided, That a person who intends to resume practice as a medical technologist, etc. after having not practiced for at least one year shall take the refresher training for the hours specified below in the year during which the person intends to resume practice:

(a) A person who has not practiced for at least one year and less than two years: At least 12 hours;

(b) A person who has not practiced for at least two years and less than three years: At least 16 hours;

(c) A person who has not practiced for at least three years: At least 20 hours;

2. Methods of the refresher training: Face-to-face training or online training using the information and communications network;

3. Content of the 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 the refresher training.

(2) In relation 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 the training, and other related matters.

[This Article Newly Inserted by Presidential Decree No. 27633, Nov. 29, 2016]

Article 12 (Re-Issuance of Licenses) (1) Grounds for re-issuing a license under Article 21 (2) of the Act are as follows:

1. Where the license has been revoked on the grounds provided for in subparagraphs 1 through 3 of Article 5 of the Act: When the grounds on which the license has been revoked cease to exist;

2. Where the 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/her violation;

3. Where the license has been revoked on the grounds provided for in Article 21 (1) 3 or 4: When one year has passed since the license of a medical technologist, etc. was revoked and the medical technologist, etc. is deeply remorseful of his/her misconduct;

4. Where the license has been revoked on the grounds provided for in Article 21 (1) 3-2: When six months have passed since the license of a medical technologist, etc. was revoked and the medical technologist, etc. is deeply remorseful of his/her misconduct.

(2) Procedures and methods for re-issuing licenses under paragraph (1) and other necessary matters shall be prescribed by Ordinance of the Ministry of Health and Welfare.

[This Article Wholly Amended by Presidential Decree No. 23802, May 22, 2012]

Article 13 (Scope of Professional Misconduct by Medical Technologists, etc.)

The following are the acts of professional misconduct referred to in Article 22 (1) 1 of the Act:

1. An act inconsistent with the scope of duties of medical technologists, etc. provided for in Article 2;

2. Performing any of the duties provided for in Article 2 without the instruction of a doctor or dentist (excluding health record administrators and opticians);

3. Performing any duty in a manner that is scientifically unproven or ethically prohibited;

4. Making a misrepresentation of any laboratory result.

[This Article Wholly Amended by Presidential Decree No. 23802, May 22, 2012]

Article 14 (Entrustment of Affairs) (1) Pursuant to Article 28 (2) of the Act, the Minister of Health and Welfare shall entrust the affairs of accepting reports filed under Article 11 (1) of the Act to the associations established based on each type of license of medical technologist, etc. pursuant to Article 16 of the Act (hereafter in this Article referred to as “Associations”).

(2) The Associations entrusted with the affairs under paragraph (1) shall report the performance of the entrusted affairs with the Minister of Health and Welfare, as prescribed by Ordinance of the Ministry of Health and Welfare.

(3) Pursuant to Article 28 (2) of the Act, the Minister of Health and Welfare shall entrust the refresher training for medical technologists, etc. provided for in Article 20 of the Act to an institution recognized as capable of conducting such refresher training among the following:

1. A junior college or higher-level school that has major courses related to the licenses for the medical technologists, etc. among the schools referred to in Article 2 of the Higher Education Act;

2. The Associations;

3. A research institute related to the duties of the medical technologists, etc.

(4) Upon entrustment of the refresher training under paragraph (3), the Minister of Health and Welfare shall give a public notice of the entrusted institution and details of the entrusted affairs.

[This Article Wholly Amended by Presidential Decree No. 25738, Nov. 19, 2014]

Article 14-2 (Handling of Sensitive Information and Personally Identifiable Information)

The Minister of Health and Welfare, the Metropolitan Autonomous City Mayor, the Special Self-Governing Province Governor, the head of a Si/Gun/ an 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 inevitable to perform the following duties:  <Amended by Presidential Decree No. 25738, Nov. 19, 2014; Presidential Decree No. 26130, Mar. 3, 2015>

1. Managing 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. Accepting reports on the status and employment status of medical technologists, etc. under Article 11 of the Act;

4. Registering the establishment of dental laboratories under Article 11-2 of the Act;

5. Registering the opening of eyeglass shops under Article 12 of the Act;

6. Accepting reports on closures of and changes in matters registered by dental laboratories and eyeglass shops under Article 13 of the Act;

7. Taking administrative measures under Articles 21 through 26 of the Act;

8. Re-issuing licenses under Article 12 of the Act.

[This Article Wholly Amended by Presidential Decree No. 23802, May 22, 2012]

Article 15 (Criteria for Imposition of Administrative Fines)

Criteria for imposing administrative fines provided for in Article 33 (1) and (2) of the Act are as specified in the attached Table.  <Amended by Presidential Decree No. 27633, Nov. 29, 2016>

[This Article Wholly Amended by Presidential Decree No. 23296, Nov. 16, 2011]