Clearer Standards Ahead for Self-Testing IVD Items in South Korea

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On September 4, 2025, South Korea’s Ministry of Food and Drug Safety (MFDS) issued an advance notice of a proposed amendment to the Regulation on the Classification and Grading of In Vitro Diagnostic (IVD) Medical Devices. The amendment is intended to clarify the criteria for classifying self-testing IVDs, thereby enhancing regulatory predictability and consistency.


Under the proposal, an IVD may be classified as a self-testing device if it:

  • Is intended for use by the general public rather than healthcare professionals;
  • Uses easily collected samples such as saliva or urine;
  • Can be used without specialized knowledge; and
  • Does not pose significant risks to individuals or public health in the event of an error.

Devices may also be classified as self-testing IVDs when needed to respond to a public health emergency under the Special Act for Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis, or for disease prevention and control under the Infectious Disease Control and Prevention Act.


Public comments on the proposal will be accepted until September 25, 2025.


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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