Korea KC Certification | GCA

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) 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...