New Classification Criteria for Self-Testing IVDs Take Effect in Korea, November 2025
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: Need for General Public Use: The device allows non-professionals to check their own physiological condition. Ease of specimen collection: The device uses easily obtainable specimens such as saliva or urine. User-friendliness: The device is designed for use by the general public without professional knowledge, featuring easy-to-understand usage procedures. Low Risk: The device for which testing errors are unlikely to pose potential harm to individuals or public health. Note : Even if all...