Posts

Showing posts with the label MarketAccess

Korea Announces Revision to KC Safety Standards for Sports Helmets

Image
On December 22, 2025, the Korean Agency for Technology and Standards (KATS) issued an administrative pre-announcement of revisions to the Standards for Handling Nonconformity with Household Product Safety Standards and the Operational Guidelines for the Safety Management of Electrical Appliances and Household Products , with the aim of enhancing the safety management efficiency of protective helmets for sports users and clarifying the scope of safety application by type. This revision serves as a follow-up to the upcoming amendment of safety standards for sports helmets , effective February 2, 2026. Public opinions will be collected until January 12, 2026. Key Revision Details Alignment of test items (materials, performance, etc.) with the updated safety standards Improved non-compliance handling criteria reflecting real-world hazard levels, such as retention system performance Addition of missing model classifications for hiking and ski helmets Clarification of types for ba...

KC Certification Requirements for Portable Bluetooth Speakers in Korea

Image
Planning Korean market entry? Master the KC certification essentials for Portable Bluetooth Speakers to enable legal sales and distribution. KC Certification Requirements for Portable Bluetooth Speakers 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 KC-approved battery shall be used. If not, the batteries must obtain safety confirmation approval. If RF module installed in the product is approved, RF test is not needed. 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 GCA Korea today to streamline your certification process and accelerate market access...

What Are the KC Certification Requirements for Smartwatches in Korea?

Image
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

Image
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...