Usability Data Becomes Mandatory in South Korea’s IVD Regulations

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On September 4, 2025, South Korea’s Ministry of Food and Drug Safety (MFDS) issued an advance notice of partial amendment to the Regulation on the Permission, Notification, and Review of In Vitro Diagnostic Medical Devices.


Key Changes

  • Self-testing in vitro diagnostic (IVD) reagents and devices must submit usability data as part of the review documents.
  • Acceptable usability data now includes reports from MFDS-designated institutions, reports from domestic or international professional institutions after testing, and data generated under the manufacturer’s quality management system.

Comments may be submitted to MFDS by September 25, 2025.


The amended provisions may also be applied to applications submitted before the enforcement date, including approvals, certifications, and technical document reviews.

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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