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Showing posts with the label MarketAccess

What Are the KC Certification Requirements for Smartwatches in Korea?

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Planning to enter the Korean market? Understanding the KC certification process is essential to ensure your smartwatch can be legally sold and distributed in Korea. Smartwatches are categorized by their communication method—Cellular or Bluetooth—and the required certifications vary accordingly.   KC Certification Requirements for Smartwatches Cellular Smartwatch (Bluetooth, 3G, LTE, 5G) Power: Battery Certification Type: KC Conformity Certification (EMC/RF/SAR) Sample Quantity: 2 normal (EMC/SAR), 1 conduction (RF)   Bluetooth Smartwatch (Bluetooth only) Power: Battery Certification Type: KC Conformity Registration (EMC/RF) Sample Quantity: 1 normal (EMC), 1 conduction (RF)   Check here for the KC certification timeline and required documents.   Notes If RF module installed in the product is approved, RF test is not needed. KC approved battery shall be used. If not, the batteries must obtain safety confirmation approval. GCA Korea pro...

Korea Pushes for New Medical Device Categories and Classification Adjustment

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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.  Medical Device Reclassification : 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 accelera...