South Korea Designates Long-term Follow-up Medical Devices

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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. Our specialties include KC EMC, KC Safety, KC Energy Efficiency, KC Automotive Components, KCsEx (ATEX, IECEx), or MFDS (Korean Medical Devices). For tailored certification and regulatory assistance, contact GCA Korea. We’re here to streamline your market access in South Korea.



Contact ⬇

Tel. +82-31-360-8180
E-mail: forest.lee@gca-kr.com

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