11/10/2025
South Korea Establishes Long-Term Follow-Up Requirements for Medical Devices
On August 20, 2025, South Korea’s Ministry of Food and Drug Safety (MFDS) issued Notification No. 2025-52, officially enacting the Regulation on the Designation of Long-Term Follow-Up Medical Devices and Submission of Real-World Use Information under the amended Medical Device Act (Act No. 20753), effective August 1, 2025.
Highlights:
-The regulation defines detailed procedures for designating medical devices that require long-term post-market follow-up and for submitting real-world use data by approved medical institutions.
-Implantable cardiac pacemakers (including electrodes), breast implants, and hip joints are among the devices subject to mandatory long-term follow-up.
-The regulation sets criteria for designation and de-designation, outlines review cycles, and establishes processes for participant registration, approval, and data submission.
-Manufacturers and institutions must submit follow-up reports semiannually or immediately in the case of serious adverse events.
This update reflects Korea’s commitment to strengthening post-market surveillance through the use of real-world evidence (RWE), aligning with global trends toward greater data transparency and patient safety.
Manufacturers operating in Korea should:
-Identify whether their devices are designated for long-term follow-up
-Prepare systems for ongoing data collection and reporting
-Review internal procedures for serious adverse event notifications
As regulatory frameworks across Asia evolve, Korea’s new approach highlights the region’s shift toward evidence, based oversight and harmonized medical device regulation.
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For the full regulation text, visit the MFDS Medical Device Regulation section:
🔗https://hubs.ly/Q03StxWN0
