MFDS Korea Proposes Simplifying Import Procedures for Personal-Use Medical Devices

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 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 opinion letters) by exempting their repeated submission, while also helping ensure continued access to necessary treatment.


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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