South Korea Sets Criteria for Designating Medical Devices Requiring Long-Term Follow-Up Studies

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Effective August 1, 2025, South Korea’s amended Enforcement Rule of the Medical Device Act will require implantable devices with frequent or potentially serious adverse events to be formally designated for mandatory long-term follow-up. The revision introduces a framework for the systematic collection, analysis, and evaluation of real-world data (RWD) generated during the use of these devices, sets out the criteria the Minister of Food and Drug Safety must apply when making designations, and authorizes the Korea Medical Device Safety Information Center to carry out the related tasks.


Key Points

  • Defines criteria for designating devices that require long-term follow-up studies
  • Empowers the Korea Medical Device Safety Information Center to collect, analyze, and evaluate RWD
  • Provides a legal basis for the Center to recruit physicians and dentists for follow-up participation
  • Specifies the RWD that participants must submit, including the date and details of device use and any associated adverse events

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.



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

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