1. Reason for the Enactment

The regulations prescribe the necessary matters related to the licensing, certification, reporting, and examination of digital medical products in accordance with the newly enacted Digital Medical Products Act (Law No. 20139; promulgated on January 23, 2024; effective from January 24, 2025) and its Enforcement Rules.

2. Main Contents

a. Definition (Draft Article 2)

The regulations clearly define the terms used in the provisions related to the licensing, certification, reporting, examination, etc. of digital medical products.

b. Provision of criteria or guidelines for licensing, certification, and reporting of digital medical products and product groups (Draft Articles 3 to 9)

The regulations provide detailed provisions on the requirements for the licensing, certification, reporting, examination, etc. of digital medical products (including those subject to exemptions), and the criteria or guidelines for permitting changes.

c. Provision of guidelines on the items to be included in applications for digital medical device licenses, certification application and declaration forms (Draft Articles 10 to 21)

The regulations provide detailed guidelines on the items to be included in applications submitted for and notification of approval, certification, or declaration of digital medical devices.

d. Provision of criteria or guidelines for digital medical devices subject to review (Draft Article 22)

The regulations provide detailed provisions on the digital medical devices subject to review and those exempted from review.

e. Provision of criteria or guidelines for digital medical devices eligible for an expedited review (Draft Article 23)

The regulations provide detailed provisions based on which the Commissioner of the Korea Food and Drug Administration (KFDA), the head of an agency providing certification services, etc. may review and approve digital medical devices expeditiously on a priority basis.

f. Criteria or guidelines for reviewing digital medical devices (Draft Article 24)

The regulations provide detailed guidelines on the reviewing of digital medical devices when the Commissioner of the Korea Food and Drug Administration (KFDA) or the head of a certification service agency, etc. receives an application for approval or certification of digital medical devices.

g. Provision of guidelines or standards for data attached to digital medical devices (Draft Articles 25 to 27)

The regulations provide detailed guidelines on the types of data or documents to be submitted for reviews of digital medical devices, cases eligible for exemption, requirements for data, etc.

h. Provision of guidelines or criteria for using the results of practical assessments (Draft Article 28)

The regulations provide detailed guidelines, including digital medical devices for which manufacturers and importers of digital medical devices may conduct a practical assessment and the method of preparing a practical use assessment plan, etc.

i. Provision of guidelines for preferential treatment based on certification of best management systems (Draft Article 29)

The regulations provide detailed provisions on the granting of preferential treatment to manufacturers that have received a certification of their best management systems.

j. Provision of procedures for approving digital convergence drugs (Draft Articles 30 to 31)

The regulations provide detailed provisions such as application form, documents to be attached, and other regulations to be considered during the examination when applying for a license for the manufacturing, sales, and importation of digital convergence drugs.

k. Provision of guidelines for assessing the performance of digital medical product components (Draft Articles 32 to 33)

The regulations provide detailed provisions on the scope of the components of digital medical products subject to a performance assessment and the requirements for the documents to be attached to the performance assessment.

l. Provision of guidelines or criteria for designating software of professional digital medical devices (Draft Article 34)

The regulations provide detailed provisions on the targets to be designated as “professional digital medical device software”, the contents to be indicated on their licenses and certificates, and advice or consultation to the Committee.

m. Provision of details for providing information on digital medical device software (Draft Article 35)

The regulations provide the details for which information should be provided on digital medical device software which incorporate artificial intelligence technologies.

o. Relationship with other notices (Draft Article 36)

The regulations provide detailed provisions on the application, with necessary modifications, of other notices for any matters that are not prescribed in relation to digital medical devices.

o. Consultation or advice (Draft Article 37)

The regulations provide detailed provisions on consultation or advice to be provided to the relevant committee as required for the licensing, certification, declaration or review of digital medical devices.

p. Verification of reliability of attached documents (Draft Article 38)

The regulations provide detailed provisions on how to verify the reliability of the test certificates or data submitted.

q. Request for and supplementation of data (Draft Article 39)

The regulations provide detailed provisions for cases in which an application for or certification of licensing, written declaration, or attachments are not created or provided in accordance with the applicable requirements.

r. Video conferencing (Draft Article 40)

The regulations provide detailed provisions for cases in which an applicant for the licensing of a digital medical product requests a meeting to be held.