Korea KC Certification | GCA

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...

On November 14, 2025, Korea’s Ministry of Food and Drug Safety (MFDS) issued an administrative notice for a proposed amendment to the Regulation on Medical Device Categories and Classification by Product Type. Public comments will be accepted until December 5, 2025. 1. New medical device subcategories: Myopia control lens Vertebral body replacement implant Fixative system for laminoplasty and laminectomy Gown, surgical Sustained release drug delivery 2.  Medical Device Reclassification : Impression, pre-treatment material, gingival retraction cord: Class II → Class I 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 accelera...

On October 22, 2025, the Ministry of Food and Drug Safety (MFDS) issued an administrative pre-announcement of the draft amendment to the Regulation on Reporting the Production, Export/Import, and Repair Performance of Medical Devices. The amendment aligns with the enforcement of the Digital Medical Products Act (effective January 24, 2025) and aims to specify reportable digital medical devices and establish new reporting forms suited to their characteristics, improving the efficiency of the reporting system. Specification of digital medical devices subject to reporting and establishment of new reporting forms for digital medical devices Reportable digital medical devices will be clearly defined, excluding standalone software. New forms will enable reporting by product code for more accurate and efficient submissions. Refinement of employee reporting forms Employee reporting forms will be standardized to ensure consistent classification across the food and drug sectors. Establishm...