South Korea Designates Long-term Follow-up Medical Devices

This notification enters into force upon promulgation. On August 20, 2025, South Korea’s Ministry of Food and Drug Safety (MFDS) enacted the Regulation on the Designation of Long-term Follow-up Medical Devices and Submission of Real-world Data . Pursuant to the amended Medical Device Act , the regulation sets forth requirements for designating long-term follow-up medical devices and for medical institutions to submit related real-world data. Key Provisions: Designation of devices: Implantable cardiac pacemakers (with electrodes), breast implants, and hip joints. Regular review: Requires periodic reviews of designations and de-designations, including review frequency. Institution participation: Provides for the registration and approval of medical institutions seeking to participate. Data submission: Outlines the items and methods for submitting real-world data. GCA Korea provides expert support for global companies navigating South Korea’s regulatory requirements....