Korea Pushes for New Medical Device Categories and Class Classification

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On November 14, 2025, Korea’s Ministry of Food and Drug Safety (MFDS) issued an administrative notice for a proposed amendment to the Regulation on Medical Device Categories and Classification by Product Type. Public comments will be accepted until December 5, 2025.


1. New medical device subcategories:

  • Myopia control lens
  • Vertebral body replacement implant
  • Fixative system for laminoplasty and laminectomy
  • Gown, surgical
  • Sustained release drug delivery


2. Device class classification:

  • Impression, pre-treatment material, gingival retraction cord: Class II → Class I

GCA Korea provides expert support for global companies navigating South 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 GCA Korea today to streamline your certification process and accelerate market access in South Korea.


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E-mail: forest.lee@gca-kr.com



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