Are Your Medical Device Products Affected? MFDS Korea Adds 4 New Device Types and a Class Change

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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 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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