MFDS Updates: Did You Know Korea Just Reduced Import Barriers for Personal-Use Medical Devices?

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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 companies navigating 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 ⬇
Tel. +82-31-360-8180
E-mail: forest.lee@gca-kr.com


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