MDREX Newsletter

2024.6.12.

MDREX, Implementation of Renewal for Medical Device Product Approval/ Certification/Notification by the Ministry of Food and Drug Safety

Starting from January 2025, the Ministry of Food and Drug Safety (MFDS) will implement administrative measures such as suspension of manufacturing, import, and sales for medical devices that have not been renewed. Accordingly, for products with renewal periods expiring in 2025, the MFDS requires submission of renewal applications between 9 months (270 days) and 6 months (180 days) prior to the expiration of the renewal period. (Currently, renewal applications are being accepted).

The renewal system for medical devices (renewal every 5 years for product approval/ certification/ notification) was newly introduced in 2020. Products approved/certified/notified before 2020 are required to be renewed sequentially from 2025 to 2029. For products approved/certified/notified after 2020, the expiration date of renewal period is indicated on the individual product’s approval certificate.

The MFDS has announced that through the renewal review process, it will verify that medical device manufacturers and importers possess test reports conducted according to the latest standards notified by the MFDS. Furthermore, if manufacturers or importers produce or import products without test reports in accordance with the latest standards (for which the renewal period has expired), the MFDS will impose strict administrative measures, including a 6-month suspension of manufacturing and import activities for all medical devices handled by the respective manufacturers and importers.

Medical device manufacturers and importers must secure test reports conducted according to the latest standards set by the MFDS before the renewal application period. While regions like Europe and the United States publish lists of harmonized standards or recognized consensus standards, South Korea specifies the latest standards through administrative rules and requires them to be documented as "applicable test standards" on the individual product’s approval/certification/notification certificate.

If the latest standards are updated, the company must comply with the requirements for manufacturers/ importers under the Medical Device Act by maintaining test reports that reflect the latest standards (including submission of test data). These reports must be verified by the MFDS (Ministry of Food and Drug Safety) through the renewal process. This is similar to the European concept of SOTA (State of the Art), but Korea uniquely requires "applicable test standards" for each product. Therefore, it is necessary to confirm these standards and prepare the relevant test reports accordingly.

For any questions regarding the domestic renewal system and the latest standards, please contact MDREX at Pro@mdrex.co.kr. If you would like to learn more about Korea's Medical Device Approval Regulations, Insurance, and Market access procedures, please visit https://www.youtube.com/@RA_QA_MA.

Thank you