CHAPTER I GENERAL PROVISIONS
The purpose of this Act is to contribute to the improvement of public health and the development of digital medical products by prescribing matters necessary for handling, managing, and supporting the manufacture, import, etc. of digital medical products, thereby ensuring the safety and efficacy of digital medical products and improving the quality thereof.
The terms used in this Act are defined as follows: <Amended on Feb. 20, 2024>
| 1. | The term "digital medical product" means digital medical devices, digital convergence drugs, and digital medical or health support devices; |
| 2. | The term "digital medical device" means a medical device defined in Article 2 (1) of the Medical Devices Act (including in vitro diagnostic medical devices defined in subparagraph 1 of Article 2 of the Act on In Vitro Diagnostic Medical Devices) to which advanced technologies prescribed by Prime Ministerial Decree, such as intelligent information technology, robot technology, and information and communications technology (hereinafter referred to as "digital technology"), are applied, or a product that combines such device with digital medical or health support devices, which falls under any of the following items: |
| a. | A product used for the purpose of diagnosis, treatment, or prognosis of diseases; |
| b. | A product used for the purpose of predicting the response to and outcome of the treatment of a disease; |
| c. | A product used for the purpose of monitoring the effects or side effects of the treatment of a disease; |
| d. | Other products designated by the Minister of Food and Drug Safety, which are used for the purpose of assisting rehabilitation; |
| 4. | The term "digital medical or health support device" means a device, machine, equipment, software, or similar products designated by the Minister of Food and Drug Safety, which does not fall under digital medical devices, but monitors, measures, collects, and analyzes biological signals for the purpose of supporting medical services or maintaining and improving health or records and analyzes lifestyle habits for the purpose of providing health management information such as diet and exercises; |
| 5. | The term "clinical study" means a study or research involving human subjects to prove the safety and efficacy of digital medical devices and digital convergence drugs; |
| 6. | The term "clinical performance study" means a study or research that analyzes a specimen (a specimen as defined in subparagraph 2 of Article 2 of the Act on In Vitro Diagnostic Medical Devices; hereinafter the same shall apply) to predict clinical, physiological, or pathological conditions or to verify the results thereof for the purpose of proving the performance of a digital medical device; |
| 7. | The term "digital medical device software" means software that constitutes a part of a digital medical device or on its own is a digital medical device, which falls under any of the following items: |
| a. | Software in a medical device: Software installed in a digital medical device or connected by wire or wireless to a digital medical device, which is used for the purpose of controlling and operating the digital medical device, or storing data generated from the digital medical device, processing signals and images, etc.; |
| b. | Software as a medical device: An independent form of software that operates in an environment equivalent to a general-purpose computer, etc. without being connected to hardware such as electronic or mechanical devices, and on its own is a digital medical device; |
| c. | Software similar to those referred to in item a or b, as designated by the Minister of Food and Drug Safety. |
| Article 3 (Classification and designation of product classes) |
| (1) | The Minister of Food and Drug Safety may classify and designate digital medical product classes so as to ensure a systematic and reasonable safety management based on differences in their intended use, functions, and potential risks to human bodies when it is used, etc.; provided, if necessary, the classification and the designation of class may be made temporarily. |
| (2) | Matters necessary for the classification and the designation of digital medical product classes under paragraph (1) shall be prescribed by Prime Ministerial Decree. |
| Article 4 (Responsibilities of the State) |
| (1) | The State and local governments shall endeavor to ensure that digital medical products are used in a safe and effective manner for the diagnosis and treatment of diseases, maintenance and promotion of health, etc. |
| (2) | The State shall establish a relevant system in order to develop a method for promptly predicting and assessing the performance, safety, and efficacy of digital medical products. |
| (3) | In order to facilitate the use of digital medical products, the State shall formulate policy measures to provide information related to digital medical products. |
| Article 5 (Relationship to other statutes) |
| (2) | Except as otherwise provided in other statutes, this Act shall apply to digital medical or health support devices. |
CHAPTER II FORMULATION OF COMPREHENSIVE SAFETY MANAGEMENT PLANS
| Article 6 (Comprehensive safety management plan for digital medical products) |
| (1) | The Minister of Food and Drug Safety shall formulate and implement a comprehensive plan for the safety management of digital medical products (hereinafter referred to as "comprehensive safety management plan") every 3 years in order to ensure the safety and efficacy, promote research and development, and strengthen the international competitiveness of digital medical products. |
| (2) | A comprehensive safety management plan shall include the following matters: |
| 1. | Policy objectives and directions for the regulatory support and safety management of digital medical products, and measures to procure financial resources; |
| 2. | Measures to improve the laws and systems related to the regulatory support and safety management of digital medical products and to advance the regulatory system; |
| 3. | Measures to support research and development to ensure the safety and efficacy of digital medical products; |
| 4. | Regulatory support for clinical studies and clinical performance studies of digital medical products, and measures to secure the safety and efficacy of digital medical products; |
| 5. | Other matters necessary for the regulatory support and safety management of digital medical products. |
| (3) | When the Minister of Food and Drug Safety formulates a comprehensive safety management plan, he or she shall consult with the heads of relevant central administrative agencies. |
| (4) | The Minister of Food and Drug Safety shall notify the heads of the relevant central administrative agencies of the established comprehensive safety management plan. |
| (5) | The Minister of Food and Drug Safety shall formulate and implement an annual implementation plan (hereinafter referred to as "implementation plan") in accordance with a comprehensive safety management plan. |
| (6) | If necessary to formulate and implement a comprehensive safety management plan and an implementation plan, the Minister of Food and Drug Safety may request the heads of relevant central administrative agencies and the heads of relevant institutions and organizations to provide necessary cooperation, such as submission of relevant data. |
| (7) | A person in receipt of a request for cooperation under paragraph (6) shall comply with such request, unless there is good cause. |
| (8) | Matters necessary for the formulation and implementation of comprehensive safety management plans and implementation plans shall be prescribed by Presidential Decree. |
| Article 7 (Advisory on digital medical products) |
| (1) | The Minister of Food and Drug Safety may, if necessary, seek advice from the following committees with regard to specialized or technical fields of digital medical products: <Amended on Feb. 20, 2024> |
| (2) | Other matters necessary for the procedures, methods, etc. for advisory shall be prescribed by Prime Ministerial Decree. |
CHAPTER III DIGITAL MEDICAL DEVICES
SECTION 1 Manufacture and Import of Digital Medical Devices
| Article 8 (Manufacturing business permission for digital medical devices) |
| (1) | A person who intends to engage in the business of manufacturing digital medical devices shall obtain manufacturing business permission from the Minister of Food and Drug Safety. In such cases, a person who has obtained manufacturing business permission (hereinafter referred to as "manufacturer of digital medical devices") shall be deemed to have obtained manufacturing business permission under Article 6 (1) of the Medical Devices Act only for digital medical devices. |
| (2) | None of the following persons may obtain manufacturing business permission: |
| 2. | A person under adult guardianship or a person who has been declared bankrupt and has not been reinstated; |
| 3. | An addict to narcotics, psychotropic drugs, or cannabis; |
| 4. | A person who has been sentenced to imprisonment without labor or a heavier punishment for violating this Act, the Medical Devices Act, or the Act on In Vitro Diagnostic Medical Devices, and for whom the sentence was not completely executed or the non-execution of such sentence has not become final and conclusive; |
| 5. | A person in whose case 1 year has not passed since his or her manufacturing business permission was revoked (excluding where his or her manufacturing business permission was revoked because he or she fell under any of subparagraphs 1 through 3) for violating this Act, the Medical Devices Act, or the Act on In Vitro Diagnostic Medical Devices. |
| (3) | A manufacturer of digital medical devices shall obtain manufacturing permission or manufacturing certification from, or file a manufacturing notification with, the Minister of Food and Drug Safety for the digital medical devices he or she intends to manufacture according to the following categorization; in such cases, a person who has obtained manufacturing permission or manufacturing certification or filed a manufacturing notification shall be deemed a person who has obtained manufacturing permission or manufacturing certification or filed a manufacturing notification pursuant to Article 6 (2) of the Medical Devices Act: |
| 1. | A digital medical device determined and publicly notified by the Minister of Food and Drug Safety, which are unlikely to cause any risk to life or health even if a failure or malfunction occurs due to the low potential risk to human body: Manufacturing permission, manufacturing certification, or manufacturing notification by product group; |
| 2. | A digital medical device other than those referred to in subparagraph 1: Manufacturing permission, manufacturing certification, or manufacturing notification by product. |
| (4) | A person who intends to obtain manufacturing business permission under paragraph (1) and a person who intends to obtain manufacturing permission or manufacturing certification or file a manufacturing notification pursuant to paragraph (3) shall first establish necessary facilities and manufacturing and quality management systems as prescribed by Prime Ministerial Decree and then apply for permission or certification or file a notification; provided, this shall not apply to cases prescribed by Prime Ministerial Decree, such as the entrustment of testing for quality management or manufacturing processes. |
| (5) | If a manufacturer of digital medical devices intends to obtain manufacturing permission or manufacturing certification or file a manufacturing notification pursuant to paragraph (3), he or she shall submit necessary data, such as manufacturing and quality management system data and clinical study data, to the Minister of Food and Drug Safety, as prescribed by Prime Ministerial Decree. In such cases, data on performance certification under Article 34 (2) shall be submitted for a digital medical or health support device constituting a part of a digital medical device. |
| (6) | If a digital medical device constitutes a part of a digital convergence drug for which permission by item has been granted pursuant to Article 29 (2), it shall be deemed that it has obtained manufacturing permission or manufacturing certification or has filed a manufacturing notification pursuant to paragraph (3). |
| (7) | A person who intends to obtain manufacturing business permission pursuant to paragraph (1) shall have a quality manager and have him or her perform functions under Article 6-2 (1) of the Medical Devices Act, as prescribed by Prime Ministerial Decree. |
| (8) | The Minister of Food and Drug Safety shall notify an applicant of whether to grant manufacturing business permission within 25 days from the date of receiving an application for manufacturing business permission under the former part of paragraph (1). |
| (9) | If the Minister of Food and Drug Safety fails to notify an applicant of whether to grant manufacturing business permission or of an extension of the handling period under statutes or regulations related to handling civil petitions within the period prescribed in paragraph (8), permission shall be deemed granted on the day following the date on which the period (where the handling period is extended or re-extended pursuant to statutes or regulations related to handling civil petitions, referring to the relevant handling period) ends. |
| (10) | Upon receipt of a manufacturing notification under paragraph (3), the Minister of Food and Drug Safety shall review the details thereof and accept the manufacturing notification if it complies with this Act. |
| (11) | Matters necessary for the subjects, procedures, standards, etc. of manufacturing business permission under the former part of paragraph (1) and manufacturing permission, manufacturing certification, or manufacturing notification under paragraph (3) shall be prescribed by Prime Ministerial Decree. |
| Article 9 (Approval of clinical study protocols) |
| (1) | A person who intends to conduct a clinical study with a digital medical device shall prepare a clinical study protocol and obtain approval from the Minister of Food and Drug Safety. The same shall also apply to any change to a clinical study protocol. |
| (2) | Notwithstanding paragraph (1), approval under paragraph (1) need not be obtained for any of the following clinical studies: |
| 1. | A clinical study for observing the clinical effects of a digital medical device on the market in terms of licensed or certified matters; |
| 2. | A clinical study which poses a low risk to human bodies, as prescribed by Prime Ministerial Decree. |
| (3) | A person who intends to manufacture or import a digital medical device for a clinical study approved pursuant to paragraph (1) shall manufacture the digital medical device in a manufacturing facility meeting the standards prescribed by Prime Ministerial Decree or import a digital medical device manufactured in such facility. In such cases, notwithstanding Articles 8 (3) and 12 (2), he or she may manufacture or import a digital medical device manufactured without obtaining permission or certification or filing a notification. |
| (5) | Notwithstanding paragraph (4), any of the following clinical studies may be conducted at an institution other than a clinical study site, as prescribed by Prime Ministerial Decree; in such cases, prior approval shall be obtained from the Minister of Food and Drug Safety, and the same shall also apply to any change to approved matters: |
| 1. | A study that collects data from a large number of people by means of communications or networks, etc.; |
| 2. | Other studies prescribed by Prime Ministerial Decree, which can be conducted by an institution other than a clinical study site in light of the characteristics of clinical studies. |
| (6) | A person who intends to conduct a clinical study with a digital medical device shall comply with the following matters: |
| 1. | A person who are confined in a social welfare facility or other communal facilities prescribed by Prime Ministerial Decree (hereinafter referred to as "institutionalized individual") shall not be selected as a subject of a clinical study; provided, if it is inevitable to select an institutionalized individual as a subject of a clinical study due to the characteristics of the clinical study and if the standards prescribed by Prime Minister Decree are met, such person may be selected as a subject of a clinical study; |
| 2. | He or she shall explain to the subject of a clinical study the details of the study, potential damage that could occur to the health of the subject during the clinical study, the details of compensation for such damage, the procedures for compensation, and other relevant matters, and obtain consent from the subject. |
| (7) | If a clinical study under paragraph (1) or (2) is deemed to pose or are likely to pose a serious risk to public health and hygiene and falls under any of the following cases, the Minister of Food and Drug Safety may change or revoke such clinical study or take other necessary measures; provided, this shall not apply where such clinical study does not negatively affect the safety, rights, or welfare of subjects or the efficacy of such clinical study or if the violation is neither repetitive nor intentional in cases falling under subparagraph 4 or 5: |
| 1. | Where a subject of a clinical study is likely to be exposed to an unexpected serious disease or injury; |
| 2. | Where a digital medical device for a clinical study is provided for commercial purposes other than for clinical studies; |
| 3. | Where it is found that the digital medical device for a clinical study is not effective; |
| 4. | Where a clinical trial violates matters for which approval or approval for change has been obtained under paragraphs (1) and (5); |
| 5. | Where a clinical study violates the standards for conducting and managing clinical studies of digital medical devices prescribed by Prime Ministerial Decree. |
| (8) | Except as provided in paragraphs (1) through (7), matters to be included in a clinical study protocol, matters necessary for the details, timing, and methods of consent from subjects of clinical studies, standards and methods for conducting and managing clinical studies, and other necessary matters shall be prescribed by Prime Ministerial Decree. |
| Article 10 (Approval of clinical performance study protocol) |
| (1) | A person who intends to conduct a clinical performance study with a digital medical device shall prepare a clinical performance study protocol and obtain approval from an institutional review board pursuant to Article 8 (2) of the Act on In Vitro Diagnostic Medical Devices, and the same shall also apply to any change to a clinical performance study protocol; provided, in cases of any of the following clinical performance studies, he or she shall obtain approval or approval for change from the Minister of Food and Drug Safety: |
| 1. | Where the method of extracting a specimen from a human body is highly risky; |
| 2. | Where it is impossible to verify the results of a clinical performance study with an already established medical diagnostic method or an authorized or certified digital medical device; |
| 3. | Where a clinical performance study is to be conducted with a digital medical device constituting a part of a digital convergence drug; provided, that this shall be limited to cases where the intended use, the operating principles, etc. are not equivalent to those of a digital medical device that has already obtained permission or certification. |
| (2) | A person who intends to manufacture or import a digital medical device for a clinical performance study approved pursuant to paragraph (1) shall manufacture the medical device in a manufacturing facility meeting the standards prescribed by Prime Ministerial Decree or import a medical device manufactured in such facility. In such cases, notwithstanding Articles 8 (3) and 12 (2), he or she may manufacture or import a digital medical device manufactured without obtaining permission or certification or filing a notification. |
| (4) | Notwithstanding paragraph (3), any of the following clinical performance studies may be conducted at an institution other than a clinical performance study site, as prescribed by Prime Ministerial Decree; in such cases, a prior approval shall be obtained from the institutional review board which has approved the clinical performance study pursuant to paragraph (1) or the Minister of Food and Drug Safety, and the same shall also apply to any change to approved matters: |
| 1. | A test that collects data from a specimen by means of communications or a network, etc.; |
| 2. | Other tests prescribed by Prime Ministerial Decree, which can be conducted at an institution other than a clinical performance study site due to the characteristics of a clinical performance study. |
| (5) | A person who intends to conduct a clinical performance study with a digital medical device shall comply with the following matters: |
| 1. | No institutionalized individual shall be selected as a subject of a clinical performance study; provided, if it is inevitable to select an institutionalized individual as a subject of a clinical performance study due to the characteristics of the clinical performance study, and if the standards prescribed by Prime Ministerial Decree are met, an institutionalized individual may be selected as a subject of a clinical performance study. |
| 2. | If a medical institution intends to use remaining specimens for a clinical performance study after using them for diagnostic or therapeutic purposes, it shall obtain written consent from the relevant specimen provider, as prescribed by Prime Ministerial Decree; provided, this shall not apply where it is exempted from written consent pursuant to the Bioethics and Safety Act; |
| 3. | A clinical performance study shall be conducted by anonymizing (referring to anonymization defined in subparagraph 19 of Article 2 of the Bioethics and Safety Act) the personal information (referring to personal information defined in subparagraph 18 of Article 2 of the Bioethics and Safety Act) of a specimen provider under subparagraph 2, as prescribed by Prime Ministerial Decree; provided, this shall not apply where the specimen provider consents to the inclusion of personally identifiable information (referring to personally identifiable information defined in subparagraph 17 of Article 2 of the Bioethics and Safety Act). |
| 4. | He or she shall comply with other standards for conducting and managing clinical performance studies prescribed by Prime Ministerial Decree. |
| (6) | If the Minister of Food and Drug Safety deems that a clinical performance study poses or is likely to pose risks to public health and hygiene, he or she may change or revoke the clinical performance study or take other necessary measures. |
| (7) | Except as provided in paragraphs (1) through (6), matters to be included in a clinical performance study protocol, matters necessary for the details, timing, and methods of consent from the subject of a clinical performance study, and standards, methods, etc. for conducting and managing clinical performance study, shall be prescribed by Prime Ministerial Decree. |
| Article 11 (Permission for change) |
| (1) | If any important matter prescribed by Prime Ministerial Decree affecting the safety and efficacy of digital medical devices among the matters for which permission or certification has been obtained or notified pursuant to Article 8 (1) and (3) has been changed, the manufacturer of digital medical devices shall obtain permission for change or certification of change from or file a notification of change with the Minister of Food and Drug Safety. In such cases, a person who has obtained permission for change or certification of change or notified change shall be deemed a person who has obtained permission for change or certification of change or notified change pursuant to Article 12 (1) of the Medical Devices Act. |
| (2) | In cases of changes not falling under paragraph (1), a manufacturer of digital medical devices shall prepare and retain records of changes and report them to the Minister of Food and Drug Safety. |
| (3) | The Minister of Food and Drug Safety shall notify an applicant of whether to grant permission for change of manufacturing business within 15 days from the date of receipt of an application for permission for change of manufacturing business under paragraph (1). |
| (4) | If the Minister of Food and Drug Safety fails to notify an applicant of whether to grant permission for change of manufacturing business or of an extension of the handling period under statutes or regulations related to handling civil petitions within the period prescribed in paragraph (3), permission shall be deemed granted on the day following the date on which the period (where the handling period is extended or re-extended pursuant to statutes or regulations related to handling civil petitions, referring to the relevant handling period) ends. |
| (5) | Matters necessary for permission for change, certification of change, or notification of change under paragraph (1), subjects, procedures, methods, and deadline for reporting changed matters under paragraph (2), and other matters shall be prescribed by Prime Ministerial Decree. |
| Article 12 (Import business permission for digital medical devices) |
| (1) | A person who intends to engage in the business of importing digital medical devices shall obtain import business permission from the Minister of Food and Drug Safety. In such cases, a person who has obtained import business permission (hereinafter referred to as "importer of digital medical devices") shall be deemed to have obtained import business permission pursuant to Article 15 (1) of the Medical Devices Act only for digital medical devices. |
| (2) | An importer of digital medical devices shall obtain import permission or import certification from or file an import notification with the Minister of Food and Drug Safety for the digital medical devices to be imported by the Minister of Food and Drug Safety according to the following categorizations; in such cases, a person who obtains import permission or import certification or files an import notification shall be deemed a person who obtains import permission or import certification or files an import notification pursuant to Article 15 (2) of the Medical Devices Act: |
| 1. | A digital medical device determined and publicly notified by the Minister of Food and Drug Safety, which are unlikely to cause any risk to life or health even if a failure or malfunction occurs due to the low potential risk to human body: Import permission, import certification, or import notification by product group; |
| 2. | Digital medical devices other than those referred to in subparagraph 1: Import permission, import certification, or import notification by product. |
| (3) | A person who intends to obtain import business permission pursuant to paragraph (1) or to obtain import permission or import certification or to file an import notification pursuant to paragraph (2) shall first establish facilities and quality management systems necessary for quality inspection and then file an application for permission or certification or file an import notification, as prescribed by Prime Ministerial Decree; provided, this shall not apply to cases prescribed by Prime Ministerial Decree, such as the entrustment of testing for quality management. |
| (4) | Article 8 (2), (5) through (11), and Article 11 shall apply mutatis mutandis to digital medical devices imported pursuant to paragraphs (1) through (3) and the importers thereof. In such cases, "manufacturing business" shall be construed as "import business", "manufacturing business permission" as "import business permission", "manufacturer of digital medical devices" as "importer of digital medical devices", "manufacturing permission" as "import permission", "manufacturing certification" as "import certification", "manufacturing notification" as "import notification", and "manufacturing and quality management system" as "quality management system", respectively. |
| Article 13 (Matters to be observed by manufacturers of digital medical devices and importers of digital medical devices) |
A manufacturer of digital medical devices and an importer of digital medical devices (hereinafter referred to as "manufacturer, etc. of digital medical devices") shall comply with the following matters, as prescribed by Prime Ministerial Decree:
| 1. | Continuously collect, manage, or remediate problems caused by defects or errors in products, such as malfunctions of digital medical devices and inadequate functions; |
| 2. | Continuously remediate vulnerabilities to electronic intrusion (hacking, computer viruses, logic or mail bombs, denial of service, high-power electromagnetic waves, etc., which affect the safety, efficacy, performance, etc. of digital medical devices; hereinafter the same shall apply); |
| 3. | Other matters prescribed by Prime Ministerial Decree for the safety management of digital medical devices and the protection of consumers. |
| Article 14 (Measures for protection from electronic intrusion) |
| (1) | In order to safely protect digital medical devices from electronic intrusion, the Minister of Food and Drug Safety shall prepare guidelines on physical and technical management systems for continuously monitoring vulnerabilities of digital medical devices and responding to electronic intrusion (hereinafter referred to as "security guidelines"). |
| (2) | A manufacturer, etc. of digital medical devices (including a person entrusted with the maintenance and management of digital medical device software pursuant to Article 26; hereafter in this Article the same shall apply) shall comply with security guidelines. |
| (3) | The Minister of Food and Drug Safety may take necessary measures, such as technical assistance, etc., for manufacturers of digital medical devices, etc. to prevent electronic intrusion and the spread thereof. |
| Article 15 (Real-world assessment) |
| (1) | A manufacturer, etc. of digital medical devices may assess the safety and efficacy of digital medical devices based on information collected and generated in the course of actual use of digital medical devices (hereinafter referred to as "real-world assessment"). |
| (2) | Notwithstanding Article 13 (3) of the Medical Devices Act, a manufacturer, etc. of digital medical devices who intends to conduct a real-world assessment may provide digital medical devices subject to the assessment to medical personnel or founders of medical institutions (including the representative or directors of a corporation, and other employees thereof) and employees of medical institutions within the scope prescribed by Prime Ministerial Decree, in order to collect data necessary for the real-world assessment. In such cases, a manufacturer, etc. of digital medical devices may make a request to medical personnel or founders and employees of medical institutions, who use the digital medical devices subject to the assessment, for the perusal of records on the relevant digital medical devices or the provision of such data. |
| (3) | The Minister of Food and Drug Safety may use data from real-world assessments submitted by manufacturers, etc. of digital medical devices for manufacturing permission, manufacturing certification, and manufacturing notification under Article 8 (3), permission for change, certification of change, and notification of change under Article 11, and import permission, import certification, import notification, etc. under Article 12 (2). |
| (4) | Details of the subjects of and procedures for real-world assessments under paragraphs (1) through (3) and the methods and procedures for the perusal or provision of copies of records under paragraph (2) shall be prescribed by Prime Ministerial Decree. |
| Article 16 (Certification of good management system) |
| (1) | The Minister of Food and Drug Safety may grant certification of a good management system to manufacturers, etc. of digital medical devices (hereinafter referred to as "certification of a good management system") in order to ensure the safety of digital medical devices and to maintain the quality thereof. |
| (2) | The standards for the certification of a good management system shall include the following matters: |
| 1. | Quality management of digital medical devices, such as development, testing, maintenance, and management thereof; |
| 2. | Safety management, such as provision of information to consumers and a response system in case of side effects; |
| 3. | A system for the prevention of and response to electronic intrusion; |
| 4. | Other matters determined by the Minister of Food and Drug Safety. |
| (3) | The valid period of certification shall be 3 years from the date the certification is granted. |
| (4) | Details of standards for the certification of a good management system under paragraph (2) shall be determined by the Minister of Food and Drug Safety. |
| Article 17 (Application for and assessment of certification of good management system) |
| (1) | A manufacturer, etc. of digital medical devices who intends to obtain the certification of a good management system shall file an application for certification with the Minister of Food and Drug Safety, as prescribed by Prime Ministerial Decree. |
| (2) | The Minister of Food and Drug Safety shall assess whether the manufacturer, etc. of digital medical devices manufacturers who have applied for the certification of a good management system meet the standards for the certification of a good management system. In such cases, the Minister of Food and Drug Safety may conduct necessary inspections, as prescribed by Prime Ministerial Decree. |
| (3) | The Minister of Food and Drug Safety may issue a certificate to a manufacturer, etc. of digital medical devices who has obtained the certification of a good management system and allow him or her to use a mark indicating certification (hereinafter referred to as "certification mark") after issuing a certificate. |
| (4) | No person who has not obtained the certification of a good management system shall manufacture or use a certificate or certification mark thereof, or use any other means to misrepresent the certification of a good management system. |
| (5) | Matters necessary for the design, method of labeling, etc. of the certification mark shall be prescribed by Prime Ministerial Decree. |
| Article 18 (Preferential treatment for manufacturers, etc. of digital medical devices who have obtained certification of good management system) |
| (1) | The Minister of Food and Drug Safety may partially exempt a manufacturer, etc. of digital medical devices who has obtained the certification of a good management system from submitting materials necessary for manufacturing permission, manufacturing certification, or manufacturing notification under Article 8 (3) and import permission, import certification, and import notification under Article 12 (2), or may determine different timing, methods, etc. for submission. |
| (2) | A manufacturer, etc. of digital medical devices who has obtained a certification of a good management system shall be deemed to have received a certification of compliance with the digital medical device software quality management standards under Article 24 (2). |
| Article 19 (Revocation of certification of good management system) |
| (1) | If a manufacturer, etc. of digital medical devices who has obtained the certification of a good management system falls under any of the following subparagraphs during the valid period under Article 16 (3), the Minister of Food and Drug Safety may revoke the certification of a good management system or order him or her to suspend the use of the certification mark or to take corrective measures; provided, if the manufacturer, etc. falls under subparagraph 1, the Minister of Food and Drug Safety shall revoke the certification of a good management system: |
| 1. | Where he or she has obtained the certification of a good management system by fraud or other improper means; |
| 2. | Where a material fact that forms the premise or basis for the certification of a good management system is changed; |
| 3. | Where he or she fails to meet the standards for certification under Article 16; |
| 4. | Where he or she violates an order to suspend the use of the certification mark or to take corrective measures. |
| (2) | Procedures necessary for the revocation of the certification of a good management system and the suspension of use of a certification mark, standards for dispositions, etc. shall be prescribed by Prime Ministerial Decree. |
| Article 20 (Digital medical device repair business) |
SECTION 2 digital medical device software
| Article 21 (digital medical device software for professional use only) |
When the Minister of Food and Drug Safety deems it necessary for professionals, such as medical personnel, to use digital medical device software in consideration of the intended use, performance, etc. of such digital medical device software, he or she may require labeling to the effect that such digital medical device software is for profession use only, as prescribed by Prime Ministerial Decree.
| Article 22 (Matters to be Stated in Digital Medical Device Software) |
A manufacturer, etc. of digital medical devices who intends to manufacture or import and distribute digital medical device software shall label or attach the following information on the digital medical device software, as prescribed by Prime Ministerial Decree:
| 1. | The trade name and address of the manufacturer of digital medical devices; |
| 2. | In the case of imported goods, the trade name and address of the importer of digital medical devices, and the manufacturer (the name of the manufacturing country and the name of the manufacturer); |
| 3. | Permission (certification or notification) number, name (product name and model name); in such cases, the product name shall apply only where the product name exists; |
| 4. | Batch number, manufacturing date, and version information; |
| 5. | Labeling that states "digital medical device software"; |
| 6. | Labeling that states "For Professional Use Only" for digital medical device software that is required to be labeled as such by the Minister of Food and Drug Safety under Article 21; |
| 7. | Unique device identifiers on medical devices determined by the Minister of Food and Drug Safety in consultation with the Minister of Health and Welfare pursuant to the Medical Devices Act; |
| 8. | Other matters prescribed by Prime Ministerial Decree. |
| Article 23 (Advertisement of digital medical device software) |
| (2) | Notwithstanding paragraph (1), with respect to advertisements of digital medical device software which is required by the Minister of Food and Drug Safety to label to the effect that such software is for professional use only pursuant to Article 21, the methods of advertisements, media, etc. may be separately prescribed by Presidential Decree. |
| Article 24 (Certification of compliance with quality management standards for digital medical device software) |
| (1) | The Minister of Food and Drug Safety may establish standards for quality management of digital medical device software (hereinafter referred to as "quality management standards") in order to prevent accidents that may occur due to defects, errors, malfunctions, etc. of digital medical device software without electronic intrusion. |
| (2) | A manufacturer, etc. of digital medical devices shall obtain a certification of compliance from the Minister of Food and Drug Safety that digital medical device software which he or she intends to manufacture or import and distribute complies with the quality management standards (hereinafter referred to as "certification of compliance"). |
| (3) | If a manufacturer, etc. of digital medical devices intends to change any matter for which a certification of compliance is obtained, he or she shall obtain a certification of compliance for such change; provided, this shall not apply where he or she intends to change any minor matter prescribed by Prime Ministerial Decree. |
| (4) | A manufacturer, etc. of digital medical devices who intends to obtain a certification of compliance or a certification of compliance for changes pursuant to paragraph (2) or (3) shall submit data on quality management, as prescribed by Prime Ministerial Decree. |
| (5) | The valid period of a certification of compliance shall be 3 years from the date on which the certification of compliance is issued. |
| Article 25 (Confirmation and inspection of certification of compliance) |
| (1) | The Minister of Food and Drug Safety shall regularly verify and inspect whether manufacturers, etc. of digital medical devices, who have obtained a certification of compliance, conforms to the quality management standards (hereinafter referred to as "regular inspection"); provided, if the Minister of Food and Drug Safety deems it necessary, he or she may conduct occasional verifications and inspections. |
| (2) | If the Minister of Food and Drug Safety deems it appropriate according to the results of a regular inspection, he or she may extend the valid period of a certification of compliance by up to 3 years. |
| (3) | In any of the following cases, the Minister of Food and Drug Safety may take necessary measures, such as revoking the certification of compliance of the relevant digital medical device software or issuing a corrective order, according to the results of verification and inspection under paragraph (1), as prescribed by Prime Ministerial Decree; provided, in cases falling under subparagraph 1 or 2, the certification of compliance shall be revoked. |
| 1. | Where it obtains a certification of compliance or a certification of compliance for changes under Article 24 (3) by fraud or other improper means; |
| 2. | Where it is subject to a disposition of business suspension under Article 50 for failing to comply with quality management standards; |
| 3. | Where it fails to comply with other matters prescribed by Prime Ministerial Decree, among other matters regarding quality management standards. |
| (4) | Matters necessary for verification and inspection under paragraph (1) shall be prescribed by Prime Ministerial Decree. |
| Article 26 (Entrustment of maintenance and management of digital medical device software) |
A manufacturer, etc. of digital medical devices may entrust a third party with the maintenance and management of digital medical device software.
| Article 27 (Special cases concerning distribution of software as a medical device) |
Notwithstanding Article 17 (1) and (2) of the Medical Devices Act, if a person who has obtained manufacturing permission or manufacturing certification or has filed a manufacturing notification pursuant to Article 8 (3) or a person who has obtained import permission or import certification or has filed an import notification pursuant to Article 12 (2) distributes software as a medical device manufactured or imported by his or her own company in the form of subscription to or provision of information and communications services, electronic installation, etc., he or she need not file a notification of distribution business, as prescribed by Prime Ministerial Decree.
| Article 28 (Partial exclusion from application of the Medical Devices Act to software as a medical device) |
CHAPTER IV DIGITAL CONVERGENCE DRUG
| Article 29 (Manufacturing business permission for digital convergence drugs) |
| (1) | A person who intends to engage in the business of manufacturing digital convergence drugs shall have necessary facilities in accordance with the facility standards prescribed by Presidential Decree and obtain permission for manufacturing business from the Minister of Food and Drug Safety. In such cases, a person who has obtained permission for manufacturing business (hereinafter referred to as "manufacturer of digital convergence drugs") shall be deemed a person who has obtained permission for manufacturing business pursuant to Article 31 (1) of the Pharmaceutical Affairs Act only for digital convergence drugs. |
| (2) | If a manufacturer of digital convergence drugs intends to distribute a digital convergence drug that he or she has manufactured (including where he or she entrusts another manufacturer of digital convergence drugs with manufacturing), he or she shall submit the following data and obtain permission for the manufacture and distribution of each item from the Minister of Food and Drug Safety (hereinafter referred to as "permission by item"); in such cases, a person who has obtained permission by item shall be deemed a person who has obtained permission by item pursuant to Article 31 (2) of the Pharmaceutical Affairs Act: |
| 1. | Data on safety and efficacy; |
| 2. | Data on manufacturing and quality management standards; |
| 3. | With respect to a digital medical device constituting a part of a digital convergence drug, data necessary for obtaining manufacturing permission or manufacturing certification or for filing a manufacturing notification, such as manufacturing and quality management system data and clinical study data under Article 8 (5); provided, if manufacturing permission or manufacturing certification is obtained or a manufacturing notification is filed for the relevant digital medical device pursuant to Article 8 (3), a permit, certificate, or notification acceptance letter may be submitted in lieu of such data; |
| 4. | Data on performance certification under Article 34 (2) with respect to a digital medical or health support device constituting a digital convergence drug; |
| 5. | Other data prescribed by Prime Ministerial Decree, as necessary for permission and safety management. |
| (3) | If a person other than a manufacturer of digital convergence drugs intends to distribute digital convergence drugs by entrusting the manufacturing of digital convergence drugs to a manufacturer of digital convergence drugs, he or she shall file a notification of a contract manufacturing and distribution business with the Minister of Food and Drug Safety and obtain permission by item. In such cases, a person who has filed a notification of contract manufacturing and distribution business shall be deemed a person who has filed a notification of contract manufacturing and distribution business under Article 31 (3) of the Pharmaceutical Affairs Act, and a person who has obtained a permission by item shall be deemed a person who has obtained a permission by item pursuant to Article 31 (3) of the Pharmaceutical Affairs Act only for digital convergence drugs. |
| (4) | A person who has obtained permission by item pursuant to paragraphs (2) and (3) may establish a place of business, as prescribed by Prime Ministerial Decree. |
| (5) | Any of the following persons shall be prohibited from obtaining permission for manufacturing business of digital convergence drugs or filing a notification of contract manufacturing and distribution business. The same shall also apply if the representative of a corporation falls under any of the following cases: |
| 1. | A mentally ill person defined in subparagraph 1 of Article 3 of the Act on the Improvement of Mental Health and the Support for Welfare functions for Mental Patients; provided, this shall not apply to a person deemed appropriate by a specialist to take charge of pharmaceutical affairs; |
| 2. | A person under adult guardianship or a person who has been declared bankrupt and has not been reinstated; |
| 3. | An addict to narcotics, psychotropic drugs, or cannabis; |
| 5. | A person in whose case 3 years have not passed since his or her license was revoked for committing a crime under Article 347 of the Criminal Act, or a person in whose case 2 years have not passed since his or her license was revoked for violating statutes or regulations governing pharmaceutical affairs; |
| 6. | A person in whose case 1 year has not passed since his or her manufacturing business permission was revoked or his or her contract manufacturing and distribution business establishment was closed under Article 50 or the Pharmaceutical Affairs Act; provided, this shall not apply to any of the following cases: |
| a. | Where he or she is deemed appropriate by a psychiatrist to take charge of pharmaceutical affairs after his or her manufacturing business permission is revoked or the contract manufacturing and distribution business establishment is closed for falling under subparagraph 1 or 3; |
| b. | Where a decision to terminate adult guardianship is made by the family court after manufacturing permission is revoked or a contract manufacturing and distribution business establishment is closed for falling under subparagraph 2. |
| (6) | When a person intends to change matters prescribed by Prime Ministerial Decree among matters permitted or notified pursuant to paragraphs (1) through (3), he or she shall obtain permission for change or file a notification of change. In such cases, a person who has obtained permission for change or filed a notification of change shall be deemed a person who has obtained permission for change or filed a notification of change pursuant to Article 31 (9) of the Pharmaceutical Affairs Act. |
| (7) | Upon receipt of a notification under paragraph (3) or (6), the Minister of Food and Drug Safety shall review the details of the notification and accept it if it complies with this Act. |
| (8) | Matters necessary for the subjects, standards, procedures, and methods of manufacturing business permission, permission by item, and notification of contract manufacturing and distribution business under paragraphs (1) through (3), and the procedures, methods, etc. for permission for and notification of change under paragraph (6) shall be prescribed by Prime Ministerial Decree. |
| Article 30 (Permission for import of digital convergence drugs) |
| (1) | A person who intends to engage in the business of importing digital convergence drugs shall file a notification of import business with the Minister of Food and Drug Safety and obtain permission for each item from the Minister of Food and Drug Safety. The same shall also apply where he or she intends to change any notified or permitted matter. |
| (2) | A person who has filed a notification of import business pursuant to paragraph (1) (hereinafter referred to as "importer of digital convergence drugs") shall be deemed an importer who has filed a notification pursuant to the former part of Article 42 (1) of the Pharmaceutical Affairs Act only for digital convergence drugs; a person who has obtained permission by item shall be deemed a person who has obtained permission by item pursuant to the former part of Article 42 (1) of the Pharmaceutical Affairs Act; and a person who has filed a notification of change or obtained permission for change shall be deemed a person who has filed a notification of change or obtained permission for change pursuant to the latter part of Article 42 (1) of the Pharmaceutical Affairs Act. |
| (3) | An importer of digital convergence drugs shall be equipped with necessary facilities, such as a place of business, in accordance with the facility standards prescribed by Presidential Decree. |
| (4) | Any of the following persons shall be prohibited from filing a notification of import business under paragraph (1). The same shall also apply where the representative of a corporation falls under any of the following cases: |
| 1. | A person who falls under any subparagraph of Article 29 (5) (excluding subparagraph 6); |
| 2. | A person in whose case 1 year has not passed since his or her place of business was closed pursuant to Article 50 or the Pharmaceutical Affairs Act; provided, any of the following cases shall be excluded herefrom: |
| a. | Where he or she is deemed appropriate by a psychiatrist to take charge of pharmaceutical affairs after the place of business is closed for falling under Article 29 (5) 1 or 3; |
| b. | Where a decision to terminate adult guardianship is made by the family court after his or her place of business is closed for falling under Article 29 (5) 2. |
| (5) | Article 29 (2) shall apply mutatis mutandis to digital convergence drugs imported pursuant to paragraph (1) and the importers thereof. In such cases, "manufacturing" shall be construed as "import", and "manufacturer of digital convergence drugs" or "person who has obtained permission by item" shall be construed as "importer of digital convergence drugs", respectively. |
| (6) | Upon receipt of a notification under paragraph (1), the Minister of Food and Drug Safety shall review the details of the notification and accept it if it complies with this Act. |
| (7) | If an importer of digital convergence drugs intends to import a digital convergence drug for which permission by item has been granted pursuant to paragraph (1), he or she shall file for registration of matters prescribed by Prime Ministerial Decree, such as the name and location of the overseas factory (referring to facilities located overseas that perform manufacturing and quality management), with the Minister of Food and Drug Safety. |
| (8) | If an importer of digital convergence drugs intends to change any matter prescribed by Prime Ministerial Decree among the matters registered pursuant to paragraph (7), he or she shall file for registration of change with the Minister of Food and Drug Safety, and if he or she changes any matter other than those prescribed by Prime Ministerial Decree, he or she shall file a notification thereof with the Minister of Food and Drug Safety. |
| (9) | Matters necessary for the subjects, standards, procedures, and methods of the notification of import business, permission by item, permission for changes, and notification of changes pursuant to paragraph (1), and the procedures and methods of registration, registration of change, and notification of change pursuant to paragraphs (7) and (8) shall be prescribed by Prime Ministerial Decree. |
| Article 31 (Clinical study of digital convergence drugs) |
| (2) | Notwithstanding paragraph (1), clinical studies of drugs constituting a part of digital convergence drugs, clinical studies of digital medical devices, and clinical performance studies of digital medical devices may be conducted separately. In such cases, paragraph (1) shall apply to clinical studies of drugs, and Articles 9 and 10 shall apply to clinical studies of digital medical devices and clinical performance studies of digital medical devices. |
| Article 32 (Application of measures to protect digital medical devices constituting part of digital convergence drugs from electronic intrusion) |
Measures for protection from electronic intrusion under Article 14, real-world assessments under Article 15, a certification of compliance with the quality management standards of digital medical device software and confirmation and inspection of compliance therewith under Articles 24 and 25 shall apply to digital medical devices constituting a part of digital convergence drug.
CHAPTER V DIGITAL MEDICAL OR HEALTH SUPPORT DEVICES
| Article 33 (Notification of manufacture or importation of digital medical or health support devices) |
| (1) | A person who intends to manufacture or import and distribute digital medical or health support devices may notify the Minister of Food and Drug Safety of the digital medical or health support devices he or she intends to distribute, as prescribed by Prime Ministerial Decree. |
| (2) | The Minister of Food and Drug Safety may register products that are notified pursuant to paragraph (1) or have obtained performance certification pursuant to Article 34 (2) in a management list (referring to a list in which the Minister of Food and Drug Safety classifies and manages digital medical or health support devices in consideration of the intended use, performance, etc. and may disclose information on the website, etc. of the Ministry of Food and Drug Safety. |
| (3) | Matters necessary for notification under paragraph (1) and disclosure of information under paragraph (2) shall be prescribed by Prime Ministerial Decree. |
| Article 34 (Performance certification of digital medical or health support devices) |
| (1) | A person who intends to manufacture or import and distribute a digital medical or health support device notified pursuant to Article 33 (1) may obtain a performance certification for the product he or she intends to distribute by filing an application for performance certification with the Minister of Food and Drug Safety. An application for performance certification may be filed simultaneously with a notification under Article 33 (1). |
| (2) | Upon receipt of an application for performance certification under paragraph (1), the Minister of Food and Drug Safety shall inspect the performance of the product, and shall grant performance certification if the product meets the performance certification standards determined by the Minister of Food and Drug Safety. |
| (3) | The Minister of Food and Drug Safety may allow the use of a mark determined by the Minister of Food and Drug Safety on packages, containers, promotional materials, etc. of products for which performance certification has been granted pursuant to paragraph (2). |
| (4) | No person who fails to obtain performance certification under paragraph (2) shall use the mark under paragraph (3). |
| (5) | The Minister of Food and Drug Safety may have a corporation or organization designated by the Minister of Food and Drug Safety as a corporation or organization whose main business is to examine the manufacturing conditions or quality of products or a testing laboratory affiliated with a State agency conduct a performance inspection under paragraph (2) on his or her behalf. |
| (6) | Except as provided in paragraphs (1) through (5), procedures and standards for performance certification, standards and procedures for designating performance inspection agencies, and other necessary matters shall be prescribed by Prime Ministerial Decree. |
| Article 35 (Distribution management of digital medical or health support devices) |
| (1) | The Minister of Food and Drug Safety may formulate and implement a plan for the distribution and management of digital medical or health support devices to verify the safety, quality, and performance of digital medical or health support devices in distribution, as prescribed by Prime Ministerial Decree. |
| (2) | If the Minister of Food and Drug Safety deems it necessary for the distribution and management of digital medical or health support devices, he or she may collect and inspect digital medical or health support devices in distribution. |
| (3) | The Minister of Food and Drug Safety may order the manufacturer, importer, or distributor of a digital medical or health support device which is deemed to pose or is likely to pose a serious risk to public health, such as false or exaggerated labeling or advertising, according to the results of collection and inspection under paragraph (2), to recall, exchange, or destroy such digital medical or health support device or suspend the distribution thereof, as prescribed by Prime Ministerial Decree. |
| (4) | If the relevant digital medical or health support devices have already been distributed and are in use, the manufacturer, importer, or distributor who has been ordered to recall, exchange, or destroy the devices, or suspend the distribution thereof pursuant to paragraph (3) shall notify the purchasers of such fact and take necessary measures, such as recall or exchange, as prescribed by Prime Ministerial Decree. |
| (5) | When the Minister of Food and Drug Safety orders recall, exchange, destruction, or suspension of distribution pursuant to paragraph (3), he or she shall publish such fact on the website, etc. of the Ministry of Food and Drug Safety, as prescribed by Prime Ministerial Decree. |
| (6) | The Minister of Health and Welfare may request the Minister of Food and Drug Safety to provide data collected and inspected pursuant to paragraph (2). |
CHAPTER VI ESTABLISHMENT OF FOUNDATION FOR DEVELOPMENT OF DIGITAL MEDICAL PRODUCTS
| Article 36 (Performance of digital-based service) |
| (1) | When the Minister of Food and Drug Safety formulates and implements policies related to digital medical products, he or she shall endeavor to ensure that each stage is continuously and complementarily implemented in consideration of the life-cycle of digital medical products which encompasses development, use, and assessment. |
| (2) | The Minister of Food and Drug Safety may establish and operate an information system based on digital technology to promptly and efficiently perform functions, such as permission, certification, notification, approval, application, determination, and assessment under this Act for the life-cycle management of digital medical products. |
| Article 37 (Impact assessment of digital medical products) |
| (1) | The Minister of Food and Drug Safety may investigate and assess the impact of the use and spread of digital medical products on the society, economy, culture, and public health (hereinafter referred to as "impact assessment"). |
| (2) | The Minister of Food and Drug Safety shall endeavor to reflect the results of impact assessment in the formulation and implementation of policies related to digital medical products. |
| (3) | The Minister of Health and Welfare may request the Minister of Food and Drug Safety to provide the results of impact assessment under paragraph (1). |
| (4) | The subjects, standards, intervals, methods, and details of the impact assessment under paragraphs (1) and (2), and other necessary matters shall be prescribed by Prime Ministerial Decree. |
| Article 38 (Request for review of health insurance benefits) |
| (1) | The Minister of Food and Drug Safety may request the Minister of Health and Welfare to expedite the determination of whether a digital medical product is eligible for health insurance benefits pursuant to Article 41(3) of the National Health Insurance Act if it is found that prompt use is necessary to improve public health based on the results of the impact assessment under Article 37. In such cases, the Minister of Health and Welfare shall comply with such request unless there is a compelling reason not to do so. |
| (2) | If the Minister of Food and Drug Safety conducts an impact assessment of the digital medical product again after making a request under paragraph (1), the Minister of Food and Drug Safety shall inform the Minister of Health and Welfare of the results. |
| Article 39 (Preliminary review of permission and notification) |
| (1) | Any of the following persons may request the Minister of Food and Drug Safety to conduct a preliminary review on data necessary for permission, certification, notification, approval, assessment, etc. of digital medical products: |
| 1. | A person who intends to obtain manufacturing permission or manufacturing certification or file a manufacturing notification pursuant to Article 8 (3); |
| 2. | A person who intends to conduct a clinical study pursuant to Article 9 or a clinical performance study pursuant to Article 10; |
| 3. | A person who intends to obtain import permission or import certification or to file an import notification pursuant to Article 12 (2); |
| 4. | A person who intends to obtain permission by item pursuant to Article 29 (2) or to obtain import permission pursuant to Article 30 (1); |
| 5. | A person who intends to obtain performance certification under Article 34; |
| 6. | A person who intends to undergo a performance assessment pursuant to Article 40. |
| (2) | Upon receipt of a request for review under paragraph (1), the Minister of Food and Drug Safety shall verify the request and notify the applicant of the results thereof in writing (including electronic documents). |
| (3) | The Minister of Food and Drug Safety shall take into account the results of review under paragraph (2) for purposes of permission, certification, notification, approval, assessment, etc. falling under the subparagraphs of paragraph (1). |
| (4) | Matters necessary for the subjects, scope, procedures, methods, etc. of preliminary reviews under paragraph (1) shall be prescribed by Prime Ministerial Decree. |
| Article 40 (Performance assessment of components of digital medical products) |
| (1) | The Minister of Food and Drug Safety may assess the performance of components that may affect the functions of digital medical products, such as sensors and artificial intelligence algorithms. |
| (2) | A person who intends to undergo an assessment under paragraph (1) shall file an application with the Minister of Food and Drug Safety. |
| (3) | Upon receipt of an application under paragraph (2), the Minister of Food and Drug Safety shall assess the performance of components. |
| (4) | The Minister of Food and Drug Safety may require a person who files an application for assessment pursuant to paragraph (2) to bear expenses incurred in conducting such assessment. |
| (5) | The Minister of Food and Drug Safety shall take into account the results of assessment under paragraph (3) for purposes of permission, certification, notification, approval, assessment, etc. for digital medical products. |
| (6) | Other details necessary for performance assessment, such as methods and procedures for filing an application for performance assessment, methods of assessment, bearing of expenses, etc. shall be prescribed by Prime Ministerial Decree. |
| Article 41 (Support for development of digital medical products and protection of intellectual property rights) |
| (1) | In order to support the development of digital medical products with safety and efficacy, the Minister of Food and Drug Safety may determine and publicly notify development standards in consideration of the following matters: |
| 1. | Application of digital technology; |
| 2. | Clinical studies and clinical performance studies; |
| 3. | Performance of digital medical or health support devices; |
| 4. | Other matters the Minister of Food and Drug Safety deems necessary for the development of digital medical products. |
| (2) | In order to protect the intellectual property rights of digital medical products, the Government may implement necessary policy measures, such as support for the prevention of illegal reproduction and distribution of digital medical products and education and publicity on intellectual property rights. |
| Article 42 (Support for research and development and standardization) |
| (1) | The Minister of Food and Drug Safety may conduct research and development projects necessary for effectively conducting the safety management of digital medical products. |
| (2) | In order to standardize technologies, standards, methods, etc. for assessing digital medical products developed through research and development projects, etc. under paragraph (1), the Minister of Food and Drug Safety may support the survey, research and development of domestic and foreign standards, establishment of infrastructure for standardization, etc. |
| Article 43 (Training of specialized human resources) |
| (1) | The Government shall endeavor to train human resources with expertise in relevant systems, statutes and regulations, control, etc. (hereinafter referred to as "specialized human resources") for the development of digital medical products, support for the commercialization of digital medical products, etc. |
| (2) | The Government may designate an institution equipped with facilities and human resources prescribed by Presidential Decree, such as universities and research institutes, as an institution for training specialized human resources, in order to develop specialized human resources. |
| (3) | If an institution for training specialized human resources designated pursuant to paragraph (2) falls under any of the following cases, the Government may revoke its designation; provided, if it falls under subparagraph 1, it shall revoke its designation: |
| 1. | Where it obtains designation by fraud or other improper means; |
| 2. | Where it ceases to meet the standards for designation of an institution for training specialized human resources for at least 3 months; |
| 3. | Where it treats a person who has not completed education as having completed such education. |
| (4) | Other matters necessary for the designation, revocation of designation, etc. of institutions for training specialized human resources shall be prescribed by Presidential Decree. |
| Article 44 (International cooperation) |
The Minister of Food and Drug Safety shall identify international trends in the regulation of digital medical products and promote international cooperation.
| Article 45 (Regulatory support center for digital medical products) |
| (1) | The Minister of Food and Drug Safety may designate a relevant specialized institution, organization, or corporation that meets the standards prescribed by Presidential Decree, such as dedicated human resources and management organizations, as a regulatory support center for digital medical products, and have it perform the following functions in order to support the examination of the safety and efficacy of digital medical products, regulatory improvements, etc.: |
| 1. | Regulatory support for the assessment of the safety and efficacy of digital medical products, such as development of digital medical products and clinical studies; |
| 2. | Collection and provision of information for the safe use of digital medical products; |
| 3. | Establishment and provision of a standard system for information and communications used for digital medical products; |
| 4. | Collection and provision of information related to regulatory harmonization for digital medical products among countries; |
| 5. | Other functions prescribed by Presidential Decree as necessary for the regulatory support of digital medical products. |
| (2) | The Minister of Food and Drug Safety may fully or partially subsidize expenses incurred by the regulatory support center for digital medical products in performing its services. |
| (3) | Other matters necessary for the designation, operation, etc. of the regulatory support center for digital medical products shall be prescribed by Presidential Decree. |
| Article 46 (Support for use of patient-specific digital medical products) |
| (1) | The Minister of Food and Drug Safety shall formulate assessment standards for the analysis, utilization, etc. of patient data in order to support the use of a digital medical product designed or used to fit the unique physiological and pathological characteristics of a patient. |
| (2) | A person who manufactures digital medical products under paragraph (1) shall comply with the matters determined by the Minister of Food and Drug Safety in relation to the retention and processing of patient data, post-market safety measures, etc. |
| Article 47 (Establishment of organizations) |
| (1) | A person who manufactures or imports digital medical products, etc. may establish an organization after obtaining authorization from the Minister of Food and Drug Safety in order to contribute to the sound development of digital medical products and the improvement of public health. |
| (2) | The organization under paragraph (1) shall be a corporation. |
| (3) | The organization established pursuant to paragraph (1) shall endeavor to maintain sound order in the manufacture, import, and distribution of digital medical products. |
| (4) | Except as provided in this Act, the provisions of the Civil Act governing incorporated associations shall apply mutatis mutandis to the organizations referred to in paragraph (1). |
| Article 48 (Designation of agency for certification affairs) |
| (1) | The Minister of Food and Drug Safety may designate an agency that meets the standards prescribed by Presidential Decree, such as dedicated human resources exclusively and management organizations, as an agency for certification, notification, determination, and assessment of digital medical products (hereinafter referred to as "agency for certification affairs, etc.") and require it to perform the following functions in order to professionally and promptly handle certification, notification, determination, and assessment of digital medical products: |
| 1. | A manufacturing certification and a manufacturing notification under Article 8 (3) and an import certification and an import notification under Article 12 (2); |
| 2. | A certification of change or notification of change under Article 11 (1); |
| 3. | A certification of a good management system; |
| 4. | A certification of compliance with the quality management standards and a certification of compliance for changes under Article 24 (2) and (3); |
| (2) | When an agency for certification affairs, etc. designated pursuant to paragraph (1) performs functions falling under the subparagraphs of paragraph (1), it shall comply with the matters prescribed by Prime Ministerial Decree, such as keeping records on certification, notification, determination, and assessment. |
| (3) | The head of an agency for certification affairs, etc. designated pursuant to paragraph (1) may request cooperation from relevant administrative agencies, institutions, organizations, etc., if necessary to perform functions under the subparagraphs of paragraph (1). |
| (4) | The Minister of Food and Drug Safety may guide and supervise agencies for certification affairs, etc. designated pursuant to paragraph (1) and may partially subsidize expenses incurred in operating such agencies. |
| (5) | Matters necessary for the standards and procedures for designating agencies for certification affairs, etc., the operation, management, etc. of such agencies shall be prescribed by Presidential Decree. |
CHAPTER VII MANAGEMENT AND SUPERVISION
| Article 49 (Reporting and inspection) |
| (1) | If deened necessary for the prevention of risks, the quality management or distribution management of digital medical products, or the management and supervision of an agency entrusted with business affairs related to digital medical products, the Minister of Food and Drug Safety may require a manufacturer, etc. of digital medical devices, a manufacturer, etc. of digital convergence medicines, a person who has obtained a permisison by item for a digital convergence medicine, an importer of digital convergence medicines, a person who has obtained approval for a clinical trial or clinical performance test plan for a digital medical device or digital convergence medicine, or a person who intends to manufacture or import and distribute a digital medical or health support device, a performance inspection agency under Article 34 (5), a regulatory support center for digital medical products under Article 45 (1), or an agency for certification affairs, etc. under Article 48 (1) to file a necessary report, or require a relevant public official to perform any of the following acts: |
| 1. | Entering a factory, warehouse, shop, or office that handles digital medical products, a site or place where a clinical study or clinical performance study is conducted, such as a clinical study site and a clinical performance study site, or any other places where digital medical products are handled for business purposes, and inspecting such facilities or relevant books or documents (including electronic documents), other devices, equipment, and things, or questioning relevant persons; |
| 2. | Collecting the minimum quantity (including electronic collection) of digital medical devices for testing or quality inspection when they are suspected of violating Article 26 of the Medical Device Act or deemed likely to cause serious damage or fatal effects on public health if used; |
| 4. | Collecting the minimum quantity (including electronic collection) of digital medical products for testing or quality inspection. |
| (2) | A public official who intends to make an entry or conduct inspection, questioning, or collection pursuant to paragraph (1) shall carry identification verifying his or her authority and show it to relevant persons. |
| (3) | Matters regarding the authority, scope of duties, identification, etc. of the relevant public officials under paragraphs (1) and (2) shall be prescribed by Prime Ministerial Decree. |
| Article 50 (Suspension of business) |
| (1) | If a manufacturer, etc. of digital medical devices, a manufacturer, etc. of digital convergence drugs, a person who has obtained permission by item for a digital convergence drug, or an importer of digital convergence drugs falls under any of the following cases, the Minister of Food and Drug Safety may revoke permission, certification, approval, or acceptance of notification, close the contract manufacturing and distribution business establishment or place of business (limited to an importer of digital convergence drugs notified pursuant to Article 30 (1); hereafter in Article 53 the same shall apply), issue an order to prohibit the manufacturing, import, or distribution of digital medical products, or order the suspension of all or part of business for a period not exceeding 1 year: |
| 1. | Where he or she has obtained permission or certification or filed a notification under Article 8 (1) or (3) or 12 (1) or (2) by fraud or other improper means; |
| 2. | Where he or she falls under any subparagraph of Article 8 (2) (including cases applied mutatis mutandis in Article 12 (4)); provided, this shall not apply where the heir transfers the status of a manufacturer of digital medical devices or importer of digital medical devices within 6 months pursuant to Article 47 (2) of the Medical Devices Act.; |
| 3. | Where he or she manufactures or imports a digital medical device without obtaining permission or certification or filing a notification, in violation of Article 8 (3) or 12 (2); |
| 4. | Where he or she fails to be equipped with facilities and manufacturing and quality management systems under the main clause of Article 8 (4) or facilities and quality management systems under the main clause of Article 12 (3); |
| 5. | Where he or she fails to appoint a quality manager, in violation of Article 8 (7) (including cases applied mutatis mutandis in Article 12 (4)); |
| 6. | Where he or she has obtained approval or approval for change under Article 9 or 10 by fraud or other improper means; |
| 7. | Where he or she manufactures digital medical devices for a clinical study or clinical performance study in a manufacturing facility not in compliance with the standards or imports digital medical devices manufactured in such facility for a clinical study or clinical performance study, in violation of Article 9 (3) or 10 (2); |
| 8. | Where he or she fails to obtain permission for or certification of change or to file a notification of change, or fails to file a report on changed matters or files a false report, in violation of Article 11 (including cases applied mutatis mutandis in Article 12 (4)); |
| 9. | Where he or she has obtained permission for or certification of change or certification of change or filed a notification of change under Article 11 (1) (including cases applied mutatis mutandis in Article 12 (4)) by fraud or other improper means; |
| 10. | Where he or she fails to comply with the matters to be observed, in violation of Article 13; |
| 11. | Where he or she fails to comply with security guidelines, in violation of Article 14 (2); |
| 12. | Where he or she fails to label or attach any of the matters referred to in the subparagraphs of Article 22 or who labels or attaches false information, in violation of Article 22; |
| 13. | Where he or she fails to obtain a certification of compliance or a certification of compliance for changes, in violation of Article 24 (2) or (3); |
| 14. | Where he or she ceases to meet the facility standards under Article 29 (1) or 30 (3); |
| 15. | Where he or she has obtained permission or permission for change or filed a notification or a notification of change under Article 29 (1), (2), or (6) by fraud or other improper means; |
| 16. | Where he or she fails to obtain permission by item, in violation of Article 29 (2) or (3); |
| 17. | Where he or she falls under any of Article 29 (5) 1 through 5 (in cases falling under subparagraph 5, limited to the importers of digital convergence drugs); provided, this shall not apply where the representative of a corporation falls under any of those provisions and is replaced within 6 months; |
| 18. | Where he or she falls under Article 29 (5) 6 or 30 (4) 2; provided, this shall not apply where the representative of a corporation falls under any of those provisions and is replaced within 6 months; |
| 19. | Where he or she fails to obtain permission or permission for change for each item or to file a notification or a notification of change for each item, in violation of Article 30 (1); |
| 20. | Where he or she obtains permission or permission for change or files a notification or a notification of change under Article 30 (1) by fraud or other improper means; |
| 21. | Where he or she fails to file for registration, registration of change, or notification of change, or files for registration, registration of change, or notification of change by fraud or other improper means, in violation of Article 30 (7) or (8); |
| 22. | Where he or she refuses, obstructs, or evades the entry, inspection, inquiry, questioning, or collection by a relevant public official under Article 49 (1); |
| 23. | Where he or she manufactures, imports, or distributes a digital medical product which poses or is likely to pose risk to public health or which is deemed non-functional, ineffective, or lacking efficacy; |
| 24. | Where he or she conducts business during the period of business suspension. |
| (2) | The standards for administrative dispositions under paragraph (1) shall be prescribed by Prime Ministerial Decree. |
CHAPTER VIII SUPPLEMENTARY PROVISIONS
| Article 51 (Disclosure of examination results) |
| (1) | If the Minister of Food and Drug Safety grants manufacturing permission or manufacturing certification or accepts a manufacturing notification pursuant to Article 8, grants import permission or certification or accepts an import notification pursuant to Article 12, grants permission by item or accepts a notification by item pursuant to Article 29 or 30, or grants performance certification pursuant to Article 34, he or she shall disclose the results of examination or review thereof; provided, if a person who has obtained permission or certification of a digital medical product, has filed a notification, or has obtained performance certification requests not to disclose the part that falls under business secrets or trade secrets, it may be disclosed except for the relevant part. |
| (2) | Matters necessary for methods, procedures, etc. of disclosing the results of examination or review under paragraph (1) shall be prescribed by Prime Ministerial Decree. |
| (1) | Any of the following persons shall pay fees, as prescribed by Prime Ministerial Decree; provided, if an agency that conducts functions on behalf of the Minister of Food and Drug Safety pursuant to Articles 34 (5) and 48 (1) (hereafter in this Article referred to as "agency") performs performance inspection, certification, notification, determination, and assessment on behalf of the Minister of Food and Drug Safety, or an institution entrusted with the functions of the Minister of Food and Drug Safety pursuant to Article 54 (2) (hereafter in this Article referred to as "entrusted institution") performs the functions entrusted by the Minister of Food and Drug Safety (hereafter in this Article referred to as "entrusted institution"), he or she shall pay fees determined by the agency or the entrusted institution to the agency or the entrusted institution: |
| 1. | A person who intends to obtain permission, certification, performance certification, approval, determination, or assessment, or file a notification under this Act; |
| 2. | A person who intends to change any matter permitted, certified, performance certified, approved, determined, assessed, or notified pursuant to this Act; |
| 3. | A person who intends to undergo a preliminary review pursuant to Article 39 (1). |
| (2) | If an agency or entrusted institution determines fees pursuant to the proviso of paragraph (1), it shall determine the standards therefor and obtain approval from the Minister of Food and Drug Safety. The same shall also apply where it intends to change approved matters. |
| (3) | If an agency or entrusted institution has collected fees pursuant to the proviso of paragraph (1), such fees shall be the revenue of the agency or entrusted institution. |
If the Minister of Food and Drug Safety intends to take any of the following administrative dispositions, he or she shall hold a hearing:
| 1. | The revocation of the certification of a good management system under Article 19 (1); |
| 2. | The revocation of a certification of compliance under Article 25 (3); |
| 3. | The revocation of the designation of an institution for training specialized human resources under Article 43 (3); |
| 4. | The revocation of permission, certification, approval, or acceptance of a notification, closure of a contract manufacturing and distribution business establishment or place of business, prohibition of manufacturing, import, or distribution of digital medical products, or suspension of all or part of business under Article 50. |
| Article 54 (Delegation and entrustment of authority) |
| (1) | The Minister of Food and Drug Safety may delegate part of his or her authority under this Act to the head of a regional office of food and drug safety, the Special Metropolitan City Mayor, a Metropolitan City Mayor, a Special Self-Governing City Mayor, a Do Governor, a Special Self-Governing Province Governor, the head of a Si/Gun/Gu (referring to the head of an autonomous Gu), or the head of a health center, as prescribed by Presidential Decree. |
| (2) | The Minister of Food and Drug Safety may entrust part of his or her functions under this Act to an institution or organization related to digital medical products, as prescribed by Presidential Decree. |
| Article 55 (Legal fiction as public officials for purposes of applying penalty provisions) |
| 1. | An executive officer or employee of an agency or organization that performs the functions of the Minister of Food and Drug Safety on behalf of the Minister pursuant to Article 34 (5) or 48 (1); |
| 2. | An executive officer or employee of an institution or organization engaged in the functions entrusted pursuant to Article 54 (2). |
CHAPTER IX PENALTY PROVISIONS
| Article 56 (Penalty provisions) |
| (1) | Any of the following persons shall be punished by imprisonment with labor for not more than 5 years or by a fine not exceeding 50 million won: |
| 1. | A person who fails to obtain permission or certification or fails to file a notification, in violation of Article 8 (1) or (3) or 12 (1) or (2); |
| 2. | A person who obtains permission or certification or files a notification under Article 8 (1) or (3) or 12 (1) or (2) by fraud or other improper means; |
| 3. | A person who fails to obtain permission or file a notification or who fails to obtain permission for change or file a notification of change, in violation of Article 29 (1) through (3) or (6); |
| 4. | A person who obtains permission or permission for change or files a notification or a notification of change under Article 29 (1) through (3) or (6) by fraud or other improper means; |
| 5. | A person who fails to obtain permission or file a notification, or fails to obtain permission for change or file a notification of change, in violation of Article 30 (1); |
| 6. | A person who obtains permission or permission for change or files a notification or a notification of change under Article 30 (1) by fraud or other improper means; |
| (2) | The imprisonment with labor and the fine referred to in paragraph (1) may be concurrently imposed. |
| Article 57 (Penalty provisions) |
| (1) | Any of the following persons shall be punished by imprisonment with labor for up to 3 years or by a fine not exceeding 30 million won: |
| 1. | A person who violates Article 9 (1), the former part of paragraph (3) of that Article, paragraph (4) of that Article, the latter part of paragraph (5) of that Article, paragraph (6) of that Article, Article 10 (1), the former part of paragraph (2) of that Article, paragraph (3) of that Article, the latter part of paragraph (4) of that Article, paragraph (5) of that Article, or Article 11 (1) (including cases applied mutatis mutandis under Article 12 (4)); |
| 2. | A person who obtains approval or approval for change under Article 9 (1), the latter part of paragraph (5) of that Article, Article 10 (1) or the latter part of paragraph (4) of that Article by fraud or other improper means; |
| 3. | A person who obtains permission for change or certification of change, or files a notification of change under Article 11 (1) (including cases applied mutatis mutandis pursuant to Article 12 (4)) by fraud or other improper means; |
| 4. | A person who fails to obtain a certification of compliance or a certification of compliance for changes, in violation of Article 24 (2) or (3). |
| (2) | The imprisonment with labor and the fine referred to in paragraph (1) may be concurrently imposed. |
| Article 58 (Penalty provisions) |
Any of the following persons shall be punished by a fine not exceeding 5 million won:
| 2. | A person who fails to label or attach any of the matters referred to in the subparagraphs of Article 22 or who labels or attaches false information, in violation of Article 22; |
| 4. | A person who fails to comply with an order to recall, exchange, or destroy a device or discontinue the distribution thereof under Article 35 (3); |
| 5. | A person who refuses, obstructs, or evades the entry, inspection, inquiry, questioning, or collection by a relevant public official under Article 49 (1); |
| 6. | A person who fails to comply with an order to suspend business issued under Article 50. |
| Article 59 (Penalty provisions) |
A person who violates Article 8 (7) (including cases applied mutatis mutandis in Article 12 (4)) shall be punished by a fine not exceeding 3 million won.
| Article 60 (Joint penalty provisions) |
If the representative of a corporation, or an agent, servant or any other employee of a corporation or individual commits a violation under Articles 56 through 59 with respect to the business of such corporation or individual, not only shall the offender be punished but the corporation or individual also shall be punished by a fine under the relevant provisions; provided, this shall not apply to cases where such corporation or individual has not been neglected to pay due attention and supervision concerning the business in order to prevent such violation.
| Article 61 (Administrative fines) |
| (1) | Any of the following persons shall be subject to an administrative fine not exceeding 5 million won: |
| 1. | A person who fails to comply with the matters to be observed, in violation of Article 13; |
| 2. | A person who fails to comply with security guidelines, in violation of Article 14 (2). |
| (2) | Administrative Fines under paragraph (1) shall be imposed and collected by the Minister of Food and Drug Safety, as prescribed by Presidential Decree. |
ADDENDA <Act No. 20139, Jan. 23, 2024>
Article 1 (Enforcement date)
This Act shall enter into force 1 year after the date of its promulgation; provided, Articles 33 through 35 shall enter into force 2 years after the date of its promulgation. Article 2 (Preparatory activities for enforcement of the Act)
The Minister of Food and Drug Safety may engage in preparatory activities necessary to formulate a comprehensive safety management plan under Article 6 and to designate an agency for certification affairs, etc. under Article 48 before this Act enters into force. Article 3 (Special cases concerning partial exclusion from application of the medical devices act to software as a digital medical device) Article 4 (Transitional measures concerning permission, certification, and notification)
| (1) | A person who has obtained manufacturing permission or import business permission under the Medical Devices Act as at the time this Act enters into force and who manufactures or imports digital medical devices shall be deemed to have obtained permission pursuant to Articles 8 (1) and 12 (1). |
| (2) | Pursuant to Article 8 (3) or 12 (2), if manufacturing permission or manufacturing certification, import permission or import certification has been obtained or a manufacturing notification or import notification has been filed with respect to a digital medical device pursuant to the Medical Devices Act as at the time this Act enters into force, it shall be deemed that permission or certification has been obtained or a notification has been filed. |
| (3) | A person who manufactures (including contract manufacturing) or imports digital convergence drugs shall be deemed to have obtained permission or filed notification in accordance with Article 29 (1) or (3) or Article 30 (1) insofar as he or she has obtained permission for drug manufacturing business or has filed a notification of import business or contract manufacturing and business in accordance with the Pharmaceutical Affairs Act at the time of enforcement of this Act. |
| (4) | A person who has obtained permission by item or permission to import an item for digital convergence drugs pursuant to the Pharmaceutical Affairs Act as at the time this Act enters into force shall be deemed to have obtained permission by item pursuant to Article 29 (2) or (3) or 30 (1). |
Article 5 (Transitional measures concerning matters to be stated on digital medical device software)
Article 6 (Transitional measures concerning dispositions)
| (1) | Public notification, disposition, and other acts related to digital medical devices and applications, notifications, and other acts filed with and done by an administrative agency under the Medical Devices Act or the Act on In Vitro Diagnostic Medical Devices before this Act enters into force shall be deemed acts corresponding thereto done by or toward an administrative agency under this Act. |
Article 7 (Transitional measures concerning administrative dispositions and penalty provisions)
ADDENDA <Presidential Decree No. 20331, Feb. 20, 2024>
Article 1 (Enforcement date)
This Act shall enter into force one year after the date of its promulgation. (Proviso Omitted.)