1. Reason for enactment

Since the Digital Medical Products Act (Law No. 20139; promulgated on January 23, 2024; implemented on January 24, 2025), which stipulates the matters necessary for the handling, management, and support of digital medical products, including their manufacturing and importation, has been enacted and is due to be enforced, the proposed Enforcement Decree is designed to provide the matters necessary for the development and implementation of a comprehensive plan for the safety management of digital medical products, methods and media for advertising digital medical device software for professionals, matters delegated and entrusted to the Minister of Food and Drug Safety, and matters necessary for their implementation.

2. Main contents

a. Details of the development of a comprehensive safety management plan (Article 2 of the draft).

It provides that the Minister of Food and Drug Safety will publish the comprehensive safety management plan in the Government Gazette and post the implementation plan on the Ministry's website, and also specifically provides the scope of requests for cooperation concerning data and products to the heads of the relevant central administrative agencies, etc. It also provides a system for evaluating and reflecting the performance of the comprehensive safety management plan, etc.

b. Methods and media for advertising digital medical device software for professionals (Article 3 of the draft)

Digital medical device software for professionals may be advertised only in specialized media targeting professionals in the medicine and pharmacy field, etc. excluding from the voluntary deliberation of advertisements under the Medical Devices Act.

c. Standards of facilities of the manufacturers and importers of digital convergence medicines (Articles 4 to 6 of the draft).

The Enforcement Decree also provides the facility standards for manufacturers and importers of digital convergence medicine and the statutory grounds for entrusting or outsourcing manufacturing or testing. It also provides the grounds for manufacturers of digital convergence medicines to utilize their facilities and equipment for other purposes when manufacturing products other than digital convergence medicines.

d. Criteria and procedures for the designation of service agencies, including professional training institutes, digital medical product regulation support centers, and certification services (Articles 7 to 9 of the draft).

It also provides the criteria, application procedures for the designation of service agencies, and changes in and management of designation-related items, including those for specialized training institutes, digital medical product regulation support centers, and certification services.

e. Delegation and entrustment of authority or duties (Article 10 of the draft)

1) The Minister of Food and Drug Safety delegates to the head of the regional food and drug safety agency the authority to issue manufacturing licenses and import business licenses for digital medical devices and digital convergence medicines, orders for the collection, inspection, exchange, abolition, or cessation of sales of digital medical health support devices, and administrative dispositions such as prohibitions of the manufacture, import, and sales of digital medical products.

2) The Minister of Food and Drug Safety designates and entrusts a cooperative agency for the development of industrial standard with such support tasks as investigation, research and development of domestic and foreign standards for the standardization of technologies, standards and methods of assessment of digital medical products, and development of the standardization infrastructure.