New Classification Criteria for Self-Testing IVDs Take Effect in Korea, November 2025

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On November 21, 2025, Korea’s Ministry of Food and Drug Safety (MFDS) issued a notification announcing a partial amendment to the Regulation on the Categories of In Vitro Diagnostic Medical Devices and Their Grades. The amendment establishes new classification criteria for self-testing in vitro diagnostic medical devices (IVDs) and took effect on the same day.


An in vitro diagnostic medical device may be classified as self-testing if it satisfies all four of the following conditions:

  1. Need for General Public Use: The device allows non-professionals to check their own physiological condition.
  2. Ease of specimen collection: The device uses easily obtainable specimens such as saliva or urine.
  3. User-friendliness: The device is designed for use by the general public without professional knowledge, featuring easy-to-understand usage procedures.
  4. Low Risk: The device for which testing errors are unlikely to pose potential harm to individuals or public health.


Note: Even if all four conditions are not met, a device may still be classified as a self-testing in vitro diagnostic medical device when necessary for public health emergency response or for the prevention and measures of infectious diseases.


GCA Korea provides expert support for global companies navigating South Korea’s regulatory requirements, including KC Certification. Our expertise covers KC EMC, KC Safety, KC Energy Efficiency, KC Automotive Components, KCsEx (ATEX, IECEx), and MFDS (Korean Medical Devices). Contact GCA Korea today to streamline your certification process and accelerate market access in South Korea.


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