November 5, 2024

On October 30, 2024, the MFDS made a legislative notice concerning a revised draft of the “Enforcement Rules for the Digital Medical Products Act” (“revised notification”), which was initially announced on July 31, 2024 (“initial notification”). These enforcement rules are scheduled to be enforced starting from January 24, 2025.

Under Article 41(4) of the Administrative Procedures Act, important modifications to the previously announced legislative notices must be re-announced for additional public review. According to Article 43 of the same Act, a minimum of 40-day comment period is required for draft amendments (or a 20-day period for administrative notices). For this re-announcement, the comment period ends on December 9, 2024. Key modifications within the revised notification are outlined below.

In the initial notification, digital medical product distributors were prohibited from selling professional digital medical device software to non-healthcare professionals. This restriction has been eliminated in the revised notification.

This revision appears to be based on the assessment that it would be impractical for digital medical product distributors to verify the professional status or occupation of their customers prior to making the sale.

2. Expansion of Scope for Pre-review (Article 45(1)(11))

In the revised notification, the scope of pre-review has been expanded to include "materials related to the classification and categorization of digital medical products" in addition to the existing pre-review items specified in the initial notification (e.g., materials related to approval assessments, such as clinical trials, etc.).

For reference, the review of medical device regulation applicability under the Medical Devices Act – namely the administrative tasks of classification and categorization (Article 60 of Regulation on the Permission, Notification, Review, etc. of Medical Devices) – is currently considered to be a simple administrative task, not subject of pre-review, with a 10-day statutory processing period and no fee. However, under the Digital Medical Products Act, classification and categorization of digital medical products will be included within the scope of pre-review, with a statutory processing period of 55 days and at a fee of KRW 524,000, following the Medical Devices Act fee structure for pre-reviews.

3. Removal of Recertification Requirements for Manufacturing and Quality Management Systems of Digital Medical Devices (Addendum Article 2)

According to the initial notification (Addendum Articles 2 and 3), when products approved under the Medical Devices Act are reclassified as digital medical devices under the Digital Medical Products Act, manufacturers were required to obtain new licenses (replacement licenses) under the Digital Medical Products Act within 1 year and also complete KGMP re-certification in accordance with the “newly established manufacturing and quality management standards for digital medical devices” within 2 years of the Act's enforcement. However, the revised notification has eliminated the KGMP re-certification requirement while maintaining the license replacement obligation.

Since the revised notification does not include a system for replacing existing KGMP certificates obtained under the Medical Devices Act (unlike the license replacement system), manufacturers will need to carefully review the upcoming 'Regulations on Manufacturing and Quality Management of Digital Medical Products' (MFDS Notification) to understand how to maintain KGMP certification for products reclassified as digital medical devices.

Please consider the above information when establishing your strategy for digital medical product approval. As a specialized consulting firm in the medical device field, MDREX promptly identifies domestic medical device regulations and supports manufacturers and importers in regulatory compliance. For assistance with medical device regulations and market entry, please contact MDREX at pro@mdrex.co.kr