Presidential Decree No. 30652, Apr. 28, 2020
| Article 1 (Purpose) |
| Article 2 (Clinical Performance Study Institutions) |
| 1. | The Public Health and Environment Research Institute under the Public Health and Environment Research Institute Act; |
| 2. | Medical schools having courses in the fields of diagnostic laboratory medicine or pathology; |
| 3. | Institutions having a full-time medical specialist in diagnostic laboratory medicine or pathology, among the institutions entrusted by the State, local governments, medical institutions, etc. with the analysis and examination, etc. of specimens. |
| Article 3 (Entrustment of Certification of In Vitro Diagnostic Test in Clinical Laboratories) |
| Article 4 (Standards and Procedures for Imposition of Penalty Surcharges) |
| (1) | The standards for imposing a penalty surcharge under Article 20 (1) of the Act shall be as specified in attached Table 1. |
| (2) | Where the Minister of Food and Drug Safety intends to impose a penalty surcharge pursuant to Article 20 (1) of the Act, he or she shall give a written notice of the payment of the penalty surcharge specifying the type of violation involved, the amount of such surcharge, the method for filing an objection, the period for raising an objection, etc. |
| (3) | A person in receipt of a notice under paragraph (2) shall pay a penalty surcharge to a collecting agency determined by the Minister of Food and Drug Safety within 20 days from the date of receipt of such notice: |
| (4) | A collecting agency that has received a penalty surcharge under paragraph (3) shall issue a receipt to the payer and notify the Minister of Food and Drug Safety of the such fact without delay. |
| Article 5 (Extension of Deadline for Payment of Penalty Surcharges and Installment Payment) |
| (1) | Where the amount of a penalty surcharge to be paid by a person subject to the imposition of the penalty surcharge pursuant to Article 20 (1) of the Act (hereinafter referred to as "person liable to pay a penalty surcharge") is not less than one million won but it is deemed difficult for the person to pay the full amount of the penalty surcharge in a lump sum due to any of the following grounds, the Minister of Food and Drug Safety may extend the deadline for payment or allow the person to pay it in installments. In such cases, the Minister of Food and Drug Safety may, if necessary, have the person liable pay a penalty surcharge provide collateral: |
| 1. | Where the person suffers a serious loss in property due to a natural disaster or other catastrophe; |
| 2. | Where the person is in a serious crisis due to the worsening of business conditions; |
| 3. | Where the person is expected to face substantial financial difficulties if he or she pays the penalty surcharge in a lump sum; |
| 4. | Where the Minister of Food and Drug Safety deems that he or she is subject to a cause similar to any of subparagraphs 1 through 3. |
| (2) | Where a person liable to pay a penalty surcharge intends to extend the deadline for payment of the penalty surcharge or to pay the penalty surcharge in installments pursuant to paragraph (1), he or shes shall file an application with the Minister of Food and Drug Safety along with documents evidencing the grounds for the extension of the deadline for payment or payment in installments 10 days prior to the deadline for payment. |
| (3) | Where the deadline for payment of a penalty surcharge is extended or payment in installments is permitted pursuant to paragraph (1), the deadline for payment shall be extended within the scope of one year from the month following the month to which the deadline for payment belongs, and the interval of installed payments shall be fixed within the scope of four months and the number of installed payments shall be limited to three times. |
| (4) | Where a person liable to pay a penalty surcharge granted an extension of the deadline for paying such penalty surcharge or permitted to pay such penalty surcharge in installments under paragraph (1) falls under any of the following cases, the Minister of Food and Drug Safety may revoke the decision to extend such deadline for payment or to permit the payment in installments and collect the penalty surcharge in a lump sum: |
| 1. | Where the person fails to pay a penalty surcharge determined to be paid in installments by the deadline for payment; |
| 2. | Where the person fails to comply with the order of the Minister of Food and Drug Safety as necessary for the change or supplementation of collateral; |
| 3. | Where the Minister of Food and Drug Safety deems it impossible to collect the full amount of the penalty surcharge or the remainder thereof, due to the compulsory execution, the commencement of an auction, a declaration of bankruptcy, the dissolution of a corporation, or cases where a person liable to pay a penalty surcharge is subject to measures to collect delinquent national tax or local tax; |
| 4. | Where the person is deemed able to pay the penalty surcharge in lump sum as any of the grounds provided in the subparagraphs of paragraph (1) has ceased to exist. |
| Article 6 (Procedures for Disposition Taken against Persons Who Fail to Pay Penalty Surcharges) |
| (1) | Where a person liable to pay a penalty surcharge fails to pay a penalty surcharge by the deadline for payment (where the payment of a penalty surcharge in installments is permitted pursuant to Article 5 (1) but the determination of payment in installments is revoked pursuant to paragraph (4) of the same Article, referring to the deadline for lump-sum payment of the relevant penalty surcharge), the Minister of Food and Drug Safety shall issue a reminder to the person liable to pay a penalty surcharge within 15 days from the date on which the deadline for payment elapses. In such cases, the deadline for payment shall be within 10 days from the date on which a reminder is issued. |
| (2) | Where a person liable to pay a penalty surcharge fails to pay a penalty surcharge by the relevant deadline for payment after receiving a written reminder under paragraph (1), the Minister of Food and Drug Safety shall revoke the disposition of imposition of a penalty surcharge pursuant to the main clause of Article 20 (4) of the Act and then issue a disposition of business suspension or collect the penalty surcharge in the same manner as delinquent national taxes are collected: |
| (3) | Where the Minister of Food and Drug Safety revokes the disposition of imposition of a penalty surcharge pursuant to the main clause of Article 20 (4) of the Act and issue a disposition of business suspension, he or she shall notify the person on whom such disposition is to be issued of the details in writing. In such cases, the written notice shall include matters necessary for the disposition of business suspension, such as the grounds for changing the original disposition and the period for the disposition of business suspension. |
| Article 7 (Organization of Committee of Experts on In Vitro Diagnostic Medical Devices) |
| (1) | The term of office of members of Committee of Experts on In Vitro Diagnostic Medical Devices under Article 21 (1) of the Act (hereinafter referred to as “Committee) shall be two years: |
| (2) | Where the Committee deems necessary for efficient examination and deliberation of the Committee, it may organize and operate up to three subcommittees for each field. |
| (3) | The Committee may have up to five researchers to conduct research on and review matters for examination and deliberation by the Committee in advance. |
| Article 8 (Exclusion from, Challenge to, and Refrainment by Members) |
| (1) | Where a member of the Committee falls under any of the following cases, he or she shall be excluded from examination and deliberation of the Committee: |
| 1. | Where a member, or his or her spouse or his or her former spouse is a party to the relevant agenda (including the executive or employee thereof if the party is a corporation, organization, etc.; hereinafter the same shall apply in this subparagraph and subparagraph 2), or is a party and joint holder of rights or joint obligator of the agenda; |
| 2. | Where a member is or was in a relative of a party to the relevant agenda; |
| 3. | Where a member or the corporation, organization, etc. to which the member belongs has offered expert testimony, statement, advice, research, services, or appraisal for the relevant agenda; |
| 4. | Where a member or the legal entity, organization, etc. to which the member belongs is or was an agent for a party to the relevant agenda; |
| 5. | Where a member has served in the corporation, organization, etc. that is a party to the relevant agenda as an executive or employee thereof during the latest three years; |
| 6. | Where the chairperson deems that a member has any substantial grounds that undermine a fair examination and deliberation of the Committee, including direct interest in the relevant agenda. |
| (2) | Where a party finds it difficult to expect a fair examination and deliberation from a member, he or she may file an application with the Committee for challenging the member, and the Committee shall decide on the application by resolution. In such cases, the member against whom the application for challenge is filed may not participate in the resolution. |
| (3) | Where a member falls under a ground for exclusion under the subparagraphs of paragraph (1) or it is deemed impracticable for a member to expect a fair examination and deliberation, he or she shall voluntarily refrain from the examination and deliberation on the relevant agenda. |
| Article 9 (Dismissal of Members) |
| 1. | Where a member becomes unable to perform his or her duties due to mental or physical disability; |
| 2. | Where a member is found to have committed any wrongdoing in connection with his or her duties; |
| 3. | Where a member is deemed unsuitable as a member due to neglect of duties, loss of dignity, or any other reason; |
| 4. | Where a member voluntarily manifests his or her unfitness to perform his or her duties; |
| 5. | Where a member fails to refrain from his or her duties pursuant to paragraph (3) of the same Article, despite falling under any of the subparagraphs of Article 8 (1). |
| Article 10 (Operation of Commission) |
| (1) | The chairperson of the Committee (hereinafter referred to as the "chairperson") shall represent the Committee and preside over the affairs of the Committee. |
| (2) | Where the chairperson is unable to perform any of his or her duties due to any unavoidable reason, a member designated by the chairperson, in advance, shall act on behalf of the chairperson. |
| (3) | 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. |
| (4) | The Committee shall have one executive secretary to conduct its affairs, who shall be appointed by the Minister of Food and Drug Safety from among public officials of the Ministry of Food and Drug Safety. |
| (5) | Where deemed necessary for the examination and deliberation of the Committee, the Committee may request relevant institutions, corporations, organizations, experts, etc. to attend a meeting of the Committee, or to present their opinions or submit materials, etc. |
| Article 11 (Detailed Rules for Operation of Committee) |
| Article 12 (Entrustment of Technical Support Projects) |
| (1) | Pursuant to Article 22 (2) of the Act, the Minister of Food and Drug Safety shall entrust technical support projects under the subparagraphs of paragraph (1) of the same Article to the National Institute of Medical Device Safety Information under Article 42 of the Medical Devices Act (hereinafter referred to as the "National Institute of Medical Device Safety Information"). |
| (2) | The National Institute of Medical Device Safety Information entrusted under paragraph (1) shall report matters concerning the project operation plan, status of project implementation, fund management plan, details of fund execution, etc. to the Minister of Food and Drug Safety, as determined by the Minister of Food and Drug Safety. |
| Article 13 (Delegation and Entrustment of Authority or Affairs) |
| (1) | The Minister of Food and Drug Safety may delegate the following authority to the heads of the regional offices of food and drug safety pursuant to Article 26 (1) of the Act: |
| 1. | Manufacturing business permission or notification of whether such manufacturing business permission is granted under the former part of Article 5 (1) of the Act and paragraph (9) of the same Article; |
| 2. | Permission for modification of manufacturing business permission, reports on modification thereof, or notification of whether permission for modification is granted under the provisions of Article 10 (1) through (3) of the Act; |
| 3. | Import business permission under the former part of Article 11 (1) of the Act or notification of whether import business permission is granted under Article 5 (9) of the Act, which is applied |
| 4. | Permission for modification of import business permission, reports on modification thereof, or notification of whether permission for modification is granted under Article 10 (1) through (3) of the Act, which are applied |
| 5. | Orders to report, and entry, inspection, inquiries, or collection under Article 16 of the Act; |
| 6. | Orders to inspect in vitro diagnostic medical devices under Article 17 of the Act; |
| 7. | Revocation of permission or certification, prohibition of manufacturing, import, or distribution of an item category or item, or orders to suspend such business affair under Article 18 of the Act; |
| 8. | Imposition and collection of a penalty surcharge under Article 20 of the Act; |
| 9. | Hearings under subparagraph 1 of Article 25 of the Act. |
| (2) | The Minister of Food and Drug Safety shall entrust the following affairs to the National Institute of Medical Device Safety Information pursuant to Article 26 (2) of the Act: |
| 1. | Manufacturing certification or manufacturing notification under Article 5 (3) of the Act; |
| 2. | Certification of modification, notification of modification, or reports on modification under Article 10 (1) and (2) of the Act; |
| 3. | Import certification or import notification under Article 11 (2) of the Act; |
| 4. | Certification of modification, notification of modification, or reports on modification of import certification or import notification under Article 10 (1) and (2), which are applied |
| (2) | The Minister of Food and Drug Safety may fully or partially subsidize expenses incurred in handling such affairs by the National Institute of Medical Device Safety Information entrusted with the affairs pursuant to paragraph (2), within the budgetary limits. |
| Article 14 (Processing Sensitive Information and Personally Identifiable Information) |
| (1) | Where it is necessary to perform the following affairs, the Minister of Food and Drug Safety (including a person delegated or entrusted with authority or affairs of the Minister of Food and Drug Safety pursuant to Article 13) may manage information on health under Article 23 (1) of the Personal Information Protection Act, information on criminal records under subparagraph 2 of Article 18 of the Enforcement Decree of the same Act, and information containing resident registration numbers or alien registration numbers under the subparagraph 1 or 4 of Article 19 of the same Decree: |
| 1. | Affairs concerning manufacturing business permission, manufacturing permission, manufacturing certification, manufacturing notification, etc. of in vitro diagnostic medical devices under Article 5 of the Act; |
| 2. | Affairs concerning designation of a clinical performance study institution under Article 8 of the Act; |
| 3. | Affairs concerning permission for modification, certification of modification, notification of modification, reports on modification, etc. under Article 10 of the Act; |
| 4. | Affairs concerning import business permission, import permission, import certification, import notification, etc. of in vitro diagnostic medical devices under Article 11 of the Act (including affairs concerning permission for modification, certification of modification, notification of modification, reports on modification, etc., which are applied |
| 5. | Affairs concerning certification of in vitro diagnostic test of a clinical laboratory or revocation of certification thereof under Article 12; |
| 6. | Affairs concerning orders to inspect in vitro diagnostic test under Article 17 of the Act; |
| 7. | Affairs concerning revocation of permission or certification, prohibition of manufacturing, import, or distribution of an item category or item, or orders to suspend such business affair under Article 18; |
| 8. | Affairs concerning revocation of designation of a clinical performance study institution or orders to suspend such business affairs under Article 19 of the Act; |
| 9. | Affairs concerning imposition and collection of a penalty surcharge under Article 20 of the Act; |
| 10. | Affairs concerning hearings under Article 25 of the Act. |
| Article 15 (Standards for Imposing Administrative Fines) |