Korea KC Certification | GCA

The Ministry of Food and Drug Safety (MFDS) announced its plan to newly designate three items as self-testing in vitro diagnostic medical devices (IVDs), aiming to enhance rapid test accessibility during infectious disease outbreaks and to promote early detection and appropriate medical response for diseases that are often avoided due to testing reluctance. ( Announcement No. 2026-159 )   Public opinions on the proposed amendment will be accepted until April 14, 2026.   The newly added self-testing IVD items are as follows. IVD reagents for self testing of Influenza virus or SARS-CoV-2 using immunological method IVD reagents for self testing of sexually transmitted infections using immunological method IVD reagents for self testing of drugs of abuse GCA Korea provides expert support for global companies navigating Korea’s regulatory requirements, including KC Certification. Our expertise covers  KC EMC ,  KC Safety ,  KC Energy Efficiency ,  ...

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...