Korea KC Certification | GCA

On October 22, 2025, South Korea’s Ministry of Food and Drug Safety (MFDS) announced an administrative notice on a partial amendment to the Medical Device Good Manufacturing Practice (GMP). The amendment aims to enhance the rationality and efficiency of the medical device conformity assessment system by introducing a basis for expedited review of life-supporting devices, removing duplicate evaluations in contract manufacturing, and clarifying the scope of on-site inspections. Key Details of the Amendment Establishment of Expedited Review Procedures A framework will allow expedited review of medical devices essential for life support, surgery, or emergency care, as well as newly developed or innovative devices. This is intended to minimize commercialization delays and improve patient access when rapid market supply is needed due to manufacturing or import suspension. Streamlining Review Procedures Between Contracting Parties If a manufacturer already holds a valid conformi...

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...

South Korea’s Ministry of Food and Drug Safety (MFDS) has announced the approval status of medical products for August 2025. Last month, a total of 118 medical products received approval, comprising 33 pharmaceuticals, 6 quasi-drugs, and 79 medical devices. This represents 95% of the average monthly approvals from the previous year (124 products) and aligns with the monthly average for the first half of this year (117 products). Notably, the “Sleep Apnea Notification Feature (SANF)”—a portable respiratory analysis software—was approved in the digital medical device sector. SANF analyzes data collected from Apple Watch (Series 9 and later, Ultra 2 and later) to provide notifications for potential sleep apnea. 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 Medic...