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MFDS Simplifies Import Procedures for Personal-Use Medical Devices. The Ministry of Food and Drug Safety (MFDS) of Korea has officially announced a partial amendment to the Regulation on Exemption from Import Requirements for Medical Devices , simplifying the process for patients with rare and intractable diseases who regularly import personal-use medical devices with no domestic equivalent for diagnosis or treatment. ( Notification No. 2026-27 ) This amendment took effect on the date of its announcement, March 31, 2026. Key Changes Before: Patients were required to re-submit a medical certificate (or doctor's opinion) every time they reimported a medical device that had previously received an import requirement exemption. After: A medical certificate (or doctor's opinion) is required only for the initial submission. For subsequent reimports, the original documentation on file is accepted in lieu of a new submission. GCA Korea provides expert support for global compan...

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 ,  ...

  The Ministry of Food and Drug Safety (MFDS) has announced a proposed amendment to the Regulation on Exemption from Import Requirements for Medical Devices, which would exempt patients with rare or intractable diseases who regularly import medical devices for personal use, due to the lack of alternative products available in Korea, from repeatedly submitting medical certificates with every import. ( Announcement No. 2026-127 ) Public opinions on the proposed amendment will be accepted until March 29, 2026. Key Changes A medical certificate (or opinion letter) will only need to be submitted only once at the initial application when applying for an import requirement exemption for personal-use medical devices. For subsequent imports, the import requirement confirmation shall be substituted with the previously submitted medical certificate (or opinion letter). The MFDS is expected to reduce the economic and administrative burden associated with obtaining medical certificates (or opin...

The Ministry of Food and Drug Safety (MFDS) has revised the  Regulation on Medical Device Groups and Class by Group  to improve the efficiency of medical device safety management. The revision addresses issues identified during the review and approval processes for medical device licensing, evaluation, and civil service handling. ( Notification No. 2026-18 ) The amendment took effect on March 9, 2026. Key Revisions 1. New Medical Device Subcategories Myopia control lens Vertebral body replacement implant Fixative system for laminoplasty and laminectomy Sustained Release Drug Delivery 2. Medical Device Class Adjustment impression, pre-treatment material, gingival retraction cord: Class II → Class I Note : Medical devices are classified into four classes, from Class I (lowest risk) to Class IV (highest risk), based on their intended use and potential impact on the human body. GCA Korea provides expert support for global companies navigating Korea’s re...

In accordance with the Digital Medical Products Act enacted in January 2025, the Ministry of Food and Drug Safety (MFDS) has officially introduced the Performance Certification System for digital medical or health support devices, effective January 24, 2026, and finalized the specific device categories under Notification No. 2026-4 . What Are Digital Medical or Health Support Devices? These refer to instruments, machines, apparatuses, software, or similar products employing digital technologies that are not classified as digital medical devices, but are used to support medical purposes or promote and maintain health. Such devices monitor, measure, collect, and analyze biometric signals, or record and analyze lifestyle habits to provide health management information (e.g., diet, exercise). Scope of Digital Medical or Health Support Devices: Heart (pulse) rate measurement using PPG (PhotoPlethysmoGram) sensors Oxygen saturation measurement using PPG sensors Body composition ...

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, 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...