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ENFORCEMENT DECREE OF THE DIGITAL MEDICAL PRODUCTS ACT

Presidential Decree No. 35230, Jan. 23, 2025

 Article 1 (Purpose)
The purpose of this Decree is to prescribe matters mandated by the Digital Medical Products Act and matters necessary for the enforcement thereof.
 Article 2 (Formulation of comprehensive safety management plans and implementation plans)
(1) When the Minister of Food and Drug Safety formulates a comprehensive plan for the safety management of digital medical products under Article 6 (1) of the Digital Medical Products Act (hereinafter referred to as the "Act") (hereinafter referred to as "comprehensive safety management plan") and an annual implementation plan under paragraph (5) of that Article (hereinafter referred to as "implementation plan"), he or she shall publish the respective details thereof by posting them on the website of the Ministry of Food and Drug Safety.
(2) The Minister of Food and Drug Safety shall evaluate the performance results of an implementation plan and reflect the results thereof in the subsequent comprehensive safety management plan and implementation plan, respectively.
(3) The Minister of Food and Drug Safety may request the heads of relevant central administrative agencies or the heads of relevant institutions or organizations to provide necessary cooperation, such as submission of data or provision of information related to the following matters, pursuant to Article 6 (6) of the Act:
1. Reorganization of policies, systems, statutes, and regulations related to the safety of digital medical products;
2. Research and development related to the safety of digital medical products;
3. Electronic intrusion and security regarding digital medical products;
4. Training human resources in field of the regulatory support and safety management of digital medical products;
5. Retention and management of records related to the safety and efficacy of digital medical products
6. Other matters deemed necessary by the Minister of Food and Drug Safety to formulate a comprehensive safety management plan and implementation plan.
 Article 3 (Facility standards for manufacturers of digital convergence drugs)
(1) A person who intends to engage in the business of manufacturing digital convergence drugs pursuant to the former part of Article 29 (1) of the Act shall be equipped with the following facilities (including apparatus; hereinafter the same shall apply) to obtain manufacturing business permission:
1. A workshop for manufacturing work;
2. A laboratory for managing the quality of raw materials, materials, and products;
3. A repository for storing raw materials, materials and products;
4. Facilities necessary for manufacturing and quality management.
(2) The facilities referred to in paragraph (1) shall meet the requirements classified as follows:
1. In the case of a drug constituting a digital convergence drug: Facilities meeting the detailed standards under Article 9 of the Decree on Facility Standards for Manufacturing Business and Importers of Drugs;
2. In the case of a digital medical device constituting a digital convergence drug: Facilities meeting the facility standards under Article 8 (4) of the Act;
3. In the case of a digital medical or health support device constituting a digital convergence drug: Facilities publicly notified by the Minister of Food and Drug Safety, such as workshops and laboratories for maintaining and managing performance certification under Article 34 (2) of the Act.
(3) Where a person falling under any subparagraph of paragraph (5) intends to manufacture a digital convergence drug, all or part of the facilities for manufacturing the goods or the components of the digital medical product may substitute the facilities for manufacturing the digital convergence drug if the facilities for manufacturing the goods or the components of a digital medical product referred to in the subparagraphs of paragraph (5) meet all of the following requirements:
1. The facilities intended to be used for the manufacture of digital convergence drugs among the facilities for the manufacture of goods other than digital convergence drugs or components of digital medical products shall comply with the subparagraphs of paragraph (1);
2. They shall be facilities without concern for contamination, electronic intrusion, or competition between digital convergence drugs and goods other than digital convergence drugs or between components of digital medical products.
(4) Notwithstanding paragraphs (1) and (2), if a person who intends to engage in the business of manufacturing digital convergence drugs entrusts a person who has obtained manufacturing business permission under Article 29 (1) of the Act (hereinafter referred to as "manufacturer of digital convergence drugs") with testing for the manufacture or quality management of digital convergence drugs, he or she need not be equipped with facilities related to the entrusted functions among facilities under paragraph (1). In such cases, the scope of entrusted persons and matters to be observed by entrusted persons shall be prescribed by Prime Ministerial Decree.
(5) If a manufacturer of digital convergence drugs falls under any of the following cases, he or she may use the manufacturing facilities of digital convergence drugs for the manufacturing of goods other than digital convergence drugs or components of digital medical products to the extent that there is no concern for contamination, electronic intrusion, competition of facilities, etc. between digital convergence drugs and goods other than digital convergence drugs or between components of digital medical products:
1. A person who has obtained permission for drug manufacturing business pursuant to Article 31 of the Pharmaceutical Affairs Act;
2. A person who has obtained permission for advanced biological product manufacturing business pursuant to Article 23 of the Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products;
3. A person who has filed for registration of the business of manufacturing or processing foods or the business of manufacturing food additives pursuant to Article 37 (5) of the Food Sanitation Act;
4. A person who has obtained permission for health functional food manufacturing business pursuant to Article 5 of the Health Functional Foods Act;
5. A person who has obtained permission for medical device manufacturing business pursuant to Article 6 of the Medical Devices Act;
6. A person who has filed for registration of cosmetic manufacturing business pursuant to Article 3 of the Cosmetics Act;
7. A person who has obtained permission for digital medical device manufacturing business pursuant to Article 8 (1) of the Act;
8. A person who has filed a manufacturing or import notification for digital medical or health support devices pursuant to Article 33 (1) of the Act;
9. A person who has undergone a performance assessment of components of a digital medical product, such as sensors and artificial intelligence algorithms, pursuant to Article 40 (3) of the Act.
 Article 4 (Facility standards for importers of digital convergence drugs)
(1) A person who has filed a notification of digital convergence drug import business pursuant to Article 30 (3) of the Act shall be equipped with the following facilities:
1. Places of business and warehouses;
2. Laboratories and facilities necessary for testing.
(2) A warehouse referred to in paragraph (1) 1 shall be capable of preventing rats, pests, etc. and shall meet the standards according to the following classifications:
1. Digital convergence drugs that require storage in low-temperature and shaded conditions: It shall be possible to store such drugs in low-temperature, shaded areas;
2. In the case of digital convergence drugs comprised of biological products: It shall be possible to store biological products;
3. In the case of digital convergence drugs consisting of narcotics and psychotropic substances: It shall be possible to store narcotics and psychotropic substances;
4. In the case of digital convergence drugs for which the storage method has been determined: It shall be possible to maintain the storage conditions.
(3) Notwithstanding paragraph (1), if a person who intends to import digital convergence drugs falls under any of the following subparagraphs, he or she need not be equipped with the following facilities among the facilities under the subparagraphs of paragraph (1):
1. Where he or she is a manufacturer of digital convergence drugs or a drug wholesaler who has obtained permission pursuant to Article 45 of the Pharmaceutical Affairs Act, and has the facilities referred to in the subparagraphs of paragraph (1): The facilities he or she owns among the facilities referred to in the subparagraphs of paragraph (1);
2. Where testing for the quality management of digital convergence drugs are entrusted, as prescribed by Prime Ministerial Decree: Facilities related to the entrusted functions.
 Article 5 (Designation of institutions for training specialized human resources)
(1) “Institutions equipped with facilities and human resources prescribed by Presidential Decree, such as universities and research institutes” in Article 43 (2) of the Act means institutions meeting all of the following standards:
1. It shall be any of the following institutions:
a. A school in which a department or faculty related to digital medical products or an organization or major corresponding thereto is established among the schools under Article 2 of the Higher Education Act;
b. A research institute established under Article 8 of the Act on the Establishment, Operation and Fostering of Government-Funded Science and Technology Research Institutes;
c. A corporation established under Article 32 of the Civil Act or the Act on the Establishment and Operation of Public Interest Corporations, which performs functions related to digital medical products;
2. It shall be equipped with the following facilities and human resources to perform the functions prescribed in Article 43 (1) of the Act:
a. An office and an education room (if an office and an education room is leased or jointly used, referring to the right to use such office and education room);
b. A person who have general supervision and control of the functions and a full-time employee who performs the functions;
c. A separate organization dedicated to the performance of the functions;
d. Other facilities and human resources publicly notified by the Minister of Food and Drug Safety as deemed necessary to train specialized human resources.
(2) A person who intends to be designated as an institution for training specialized human resources under Article 43 (2) of the Act (hereinafter referred to as "institution for training specialized human resources") shall submit an application for an institution for training specialized human resources prescribed by Prime Ministerial Decree to the Minister of Food and Drug Safety, along with the following documents:
1. A business plan for training specialized human resources;
2. Data on the status of facilities and human resources related to education and training;
3. A plan to secure funding to cover operating expenses related to education and training;
4. Operational regulations on education and training;
5. Documents publicly notified by the Minister of Food and Drug Safety as deemed necessary for training specialized human resources.
(3) Upon receipt of an application under paragraph (2), the Minister of Food and Drug Safety shall verify a corporate registration certificate (applicable only to a corporation) through administrative data matching under Article 36 (1) of the Electronic Government Act.
(4) If the Minister of Food and Drug Safety designates an institution for training specialized human resources, he or she shall issue a certificate of designation prescribed by Prime Ministerial Decree to the applicant.
(5) If the Minister of Food and Drug Safety designates an institution for training specialized human resources pursuant to Article 43 (2) of the Act or revokes the designation thereof pursuant to paragraph (3) of that Article, he or she shall publish such fact on the website of the Ministry of Food and Drug Safety.
(6) Matters necessary for the change, etc. of the designated details of an institution for training specialized human resources pursuant to paragraph (4) shall be prescribed by Prime Ministerial Decree.
 Article 6 (Designation of regulatory support center for digital medical products)
(1) “Specialized institution, organization, or corporation that meets the standards prescribed by Presidential Decree, such as dedicated human resources and management organizations” in the provisions, with the exception of the subparagraphs, of Article 45 (1) of the Act means specialized institutions, organizations, or corporations that meet all of the following standards:
1. It shall be any of the following specialized institutions, organizations, or corporations:
a. An organization established with authorization from the Minister of Food and Drug Safety under Article 47 of the Act;
b. A corporation established under Article 32 of the Civil Act or the Act on the Establishment and Operation of Public Interest Corporations, which performs functions related to digital medical products;
c. A specialized institution, organization, or corporation publicly notified by the Minister of Food and Drug Safety as a specialized institution, organization, or corporation equivalent to those provided in items (a) and (b);
2. It shall have the following dedicated human resources, management organizations, etc. necessary to perform the functions prescribed in the subparagraphs of Article 45 (1) of the Act:
a. A person who has general supervision and control of the functions and full-time employees who perform the functions referred to in Article 45 (1) 1 through 4 of the Act and the subparagraphs of paragraph (2) of this Article;
b. A separate organization dedicated to the performance of the functions;
c. An office necessary for performing the functions (where an office is leased or jointly used, referring to the right to use such office);
(d) Other human resources and organizations publicly notified by the Minister of Food and Drug Safety as deemed necessary for regulatory support of digital medical products.
(2) “Functions prescribed by Presidential Decree” in Article 45 (1) 5 of the Act means the following functions:
1. Support for the prevention of electronic intrusion and the spread thereof under Article 14 (3) of the Act;
2. Support for the performance certification of digital medical or health support devices under Article 34 of the Act;
3. Support for the performance assessments of components of digital medical products under Article 40 of the Act;
4. Support for research and development under Article 42 (1) of the Act;
5. Support for international cooperation related to the regulation of digital medical products under Article 44 of the Act.
(3) A person who intends to be designated as a regulatory support center for digital medical products under Article 45 (1) of the Act (hereinafter referred to as "regulatory support center") shall submit an application prescribed by Prime Ministerial Decree to the Minister of Food and Drug Safety, along with the following documents:
1. An operational plan for the regulatory support center;
2. Data on the current status of securing human resources, organization, facilities, and equipment of the regulatory support center;
3. A plan to secure funding to cover the operating expenses of the regulatory support center;
4. Operational regulations of the regulatory support center.
(4) Upon receipt of an application under paragraph (3), the Minister of Food and Drug Safety shall verify a corporate registration certificate (applicable only to a corporation) through administrative data matching under Article 36 (1) of the Electronic Government Act.
(5) If the Minister of Food and Drug Safety designates a regulatory support center, he or she shall issue a certificate of designation prescribed by Prime Ministerial Decree to the applicant. In such cases, the Minister of Food and Drug Safety may designate a regulatory support center by specifying the scope of regulatory support functions.
(6) A person designated as a regulatory support center shall submit a business plan, budget bill, and statement of accounts related to the relevant regulatory support functions to the Minister of Food and Drug Safety and obtain approval therefor from the Minister of Food and Drug Safety every year by the date classified as follows, and report the business results:
1. A business plan and a budget bill: December 31 of the immediately preceding business year;
2. The statement of accounts and the business results: January 31 of the following business year.
(7) Matters necessary for change, etc. of the designated details of a regulatory support center pursuant to paragraph (5) shall be prescribed by Prime Ministerial Decree.
 Article 7 (Designation and operation of agency for certification affairs)
(1) “Institution that meets the standards prescribed by Presidential Decree, such as dedicated human resources and management organizations” in the provisions, with the exception of its subparagraphs, of Article 48 (1) of the Act means any of the following institutions:
1. The National Institute of Medical Device Safety Information under Article 42 of the Medical Devices Act;
2. An institution that meets all of the following requirements necessary for performing the functions prescribed in the subparagraphs of Article 48 (1) of the Act:
a. The business details of the relevant institution shall include functions regarding the certification, notification, determination, and assessment of digital medical products under Article 48 (1) of the Act (hereinafter referred to as "certification affairs, etc.");
b. There shall be a person who has general supervision and control of the functions and a full-time employee who performs the functions for each certification affairs, etc.; provided, the requirements for full-time employees shall not apply to authentication and notification of changes under Article 48 (1) 2 of the Act;
c. It shall have an organization dedicated to performing certification affairs, etc.;
d. It shall be equipped with an exclusive business space and facilities necessary for conducting certification affairs, etc.;
e. It shall have the financial capacity to perform certification affairs, etc. (excluding impact assessment under Article 48 (1) 6 of the Act);
f. It shall meet the standards publicly notified by the Minister of Food and Drug Safety as deemed necessary for certification affairs, etc.
(2) A person who intends to be designated as an agency for certification affairs, etc. under Article 48 (1) of the Act (hereinafter referred to as "agency for certification affairs, etc.") shall submit an application prescribed by Prime Ministerial Decree to the Minister of Food and Drug Safety, along with the following documents:
1. Documents regarding the current status of organizational structure and human resources of the agency for certification affairs, etc.;
2. Documents regarding operational standards for the agency for certification affairs, etc.;
3. Documents proving that the personnel performing the functions have expertise in the certification affairs, etc. which the agency for certification affairs, etc. intends to perform;
4. Documents publicly notified by the Minister of Food and Drug Safety, which verify that an agency for certification affairs, etc. has financial capacity to perform certification affairs, etc. (excluding impact assessment under Article 48 (1) 6 of the Act).
(3) Upon receipt of an application under paragraph (2), the Minister of Food and Drug Safety shall verify a corporate registration certificate (applicable only to a corporation) through administrative data matching under Article 36 (1) of the Electronic Government Act.
(4) Upon receipt of an application under paragraph (2), the Minister of Food and Drug Safety may conduct an on-site inspection to evaluate whether the details of the application meet the standards for designation.
(5) If the Minister of Food and Drug Safety designates an agency for certification affairs, etc., he or she shall issue a certificate of designation prescribed by Prime Ministerial Decree to the applicant.
(6) Matters necessary for the change, etc. of the designated details of an agency for certification affairs, etc. pursuant to paragraph (5) shall be prescribed by Prime Ministerial Decree.
(7) The Minister of Food and Drug Safety shall regularly verify the following matters with respect to an agency for certification affairs, etc.:
1. Whether it has violated the Act in the course of performing certification affairs, etc.;
2. The current status of the management of fees;
3. Other matters publicly notified by the Minister of Food and Drug Safety as necessary for performing certification affairs, etc.
 Article 8 (Delegation of authority)
The Minister of Food and Drug Safety may delegate the following authority to the heads of regional offices of food and drug safety pursuant to Article 54 (1) of the Act:
1. Manufacturing business permission under the former part of Article 8 (1) of the Act;
2. Permission for change of manufacturing business permission and reporting on change under Article 11 (1) through (3) of the Act;
3. Import business permission under the former part of Article 12 (1) of the Act;
4. Permission for change of import business permission and reporting on change under Article 11 (1) through (3) of the Act which shall apply mutatis mutandis pursuant to Article 12 (4) of the Act;
5. Certification of compliance and inspections under Article 25 (1) of the Act;
6. Necessary measures, such as the revocation of certification of confirmation and corrective orders under Article 25 (3) of the Act;
7. Manufacturing business permission and permission for the change thereof under the former part of Article 29 (1) of the Act and paragraph (6) of that Article;
8. Acceptance of the notification of contract manufacturing and distribution business and notification of the change thereof under Article 29 (3), (6), and (7) of the Act;
9. Acceptance of import business notification and notification of the change thereof under Article 30 (1) and (6) of the Act;
10. Collection and inspection of digital medical or health support devices under Article 35 (2) of the Act;
11. An order to recall, exchange, or destroy digital medical or health support devices or to suspend the sale thereof under Article 35 (3) of the Act;
12. Orders to report, and entry, inspection, inquiries, or collection under Article 49 of the Act;
13. Revocation of permission, certification, approval, or acceptance of notification under Article 50 of the Act, closure of an entrusted manufacturing and distribution business establishment or places of business, prohibition of the manufacture, import, or sale of digital medical products, or suspension of all or part of business;
14. Hearings provided in subparagraphs 2 and 4 of Article 53 of the Act.
 Article 9 (Processing of sensitive information and uniquely identifiable information)
The Minister of Food and Drug Safety (including a person to whom the authority of the Minister of Food and Drug Safety is delegated pursuant to Article 54 of the Act) and an agency for certification affairs, etc. (limited to business affairs referred to in subparagraph 3) may manage data containing information on health referred to in Article 23 of the Personal Information Protection Act (limited to business affairs referred to in subparagraphs 1, 2, 4 and 5), information corresponding to criminal history records referred to in subparagraph 2 of Article 18 of the Enforcement Decree of that Act (limited to information violating statutes and regulations related to drugs and medical devices, but limited to business affairs referred to in subparagraphs 1, 2, 4 and 5), and data containing resident registration numbers and alien registration numbers referred to in subparagraphs 1 and 4 of Article 19 of that Enforcement Decree, if it is unavoidable to perform the following functions:
1. Business affairs regarding manufacturing business permission for digital medical devices and permission for the change thereof, etc. under Articles 8 and 11 of the Act;
2. Business affairs regarding import business permission for digital medical devices and permission for the change thereof under Article 12 of the Act;
3. Business affairs regarding the certification of compliance with the quality management standards for digital medical device software under Article 24 of the Act;
4. Business affairs regarding manufacturing business permission of digital convergence drugs, permission for the change thereof, notification of contract manufacturing and distribution business of digital convergence drugs, notification of the change thereof, etc. under Article 29 of the Act;
5. Business affairs regarding notification of import business of digital convergence drugs and notification of the change thereof under Article 30 of the Act;
6. Business affairs regarding the issuance of identification to relevant public officials for entry, inspection, questioning, and collection under Article 49 of the Act to verify their authority;
7. Business affairs regarding administrative dispositions under Article 50 of the Act;
8. Business affairs regarding hearings under Article 53 of the Act.
 Article 10 (Re-examination of regulation)
The Minister of Food and Drug Safety shall examine the appropriateness of the standards for designation of institutions for training specialized human resources under Article 5 every 3 years, counting from January 1, 2025 (referring to the period that ends on the day before January 1 of every 3rd year) and shall take measures, such as making improvements.
 Article 11 (Criteria for imposition of administrative fines)
The standards for imposing administrative fines under Article 61 (1) of the Act shall be as specified in the Appendix.
ADDENDA <Presidential Decree No. 35230, Jan. 23, 2025>
Article 1 (Enforcement date)
This Decree shall enter into force on January 24, 2025; provided, Article 3 (2) 3, (5) 8, 6 (2) 2, and 8 subparagraphs 10 and 11 shall enter into force on January 24, 2026.
Article 2 Omitted.