Korea Pushes for New Medical Device Categories and Class Classification
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 a...