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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...