Korea KC Certification | GCA

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...

On November 14, 2025, MCEE* issued a notification on the creation of a List of Products Subject to Sustainable Use under Korea’s Act on Promoting the Circular Economy Transition . The policy extends beyond requiring spare parts availability, mandating manufacturers to design products for easier repair and disclose repair information. This update aligns Korea with global “Right to Repair” initiatives in the EU and the U.S. The target products are those for which the Korea Consumer Dispute Resolution Standards stipulate a parts retention period of three years or more. Targeted categories include: Home appliances: televisions, refrigerators, air conditioners, washing machines, vacuum cleaners, electric cooking devices, etc. Automobiles and motorcycles Boilers Office equipment, electrical and telecommunications devices, optical products Digital pianos and fitness equipment Agricultural and fishery machinery * MCEE: Korea’s Ministry of Climate, Energy and Environment (fo...

KATS* conducted safety inspections on 1,100 products identified as having high noncompliance rates or frequent safety incidents. As a result, the agency ordered recalls for 63 products that failed to meet national safety standards.   Among the recalled products, children’s items accounted for 42 cases, the largest portion of the total, including children’s textiles with unsafe cords or drawstrings and toys containing excessive levels of lead, preservatives, and boron.   Under the Special Act on the Safety of Children’s Products, children’s goods in Korea are managed under three categories: safety certification, safety confirmation, and supplier’s declaration of conformity (SDoC). Even certified products face routine inspections to ensure continued compliance. Noncompliant products may face recalls, sales bans, or corrective orders.   * KATS: Korean Agency for Technology and Standards   GCA KOREA provides a comprehensive one-stop service covering impor...

On November 5, 2025, the MSIT* issued a notification that the Technical Standards for Charging and Data Transmission Methods for mobile and smart devices, originally scheduled to start in February 2025 but delayed, will take effect on November 6, 2026. As previously announced in 2024: The standards apply to mobile and smart devices that support wired charging or both wired charging and data transfer. Products within scope must be equipped with USB Type-C receptacle connectors compliant with the relevant specification, which will be added to the Supplier’s Declaration of Conformity (SDoC) target items under KC EMC once the standards take effect. Covered devices include mobile phones, tablets, digital cameras, headphones, headsets, handheld game consoles, portable speakers, e-book readers, keyboards, mice, portable navigation devices, earphones, and laptops. * MSIT: the Ministry of Science and ICT in Korea GCA Korea provides expert support for global companies navigating ...

On November 3, 2025, the KATS* announced a draft amendment to Appendix 52 (Protective helmets and their visors for motorized vehicle users) of the safety standards for Consumer products subject to safety verification. Public opinions on the proposed changes are accepted until November 28, 2025. Main Amendments Newly cite international standards such as ISO/CIE 11664-1 and ISO/CIE 11664-2, and update helmet types Relax penetration resistance test criteria to align with international standards Expand test headform sizes from 3 to 6 and improve size labeling from XS to XXL for users Establish standards for photochromic eye protectors and add warnings for helmets without chin straps * KATS: Korea Agency for Technology and Standards GCA Korea provides expert support for global companies navigating South Korea’s regulatory requirements. Our specialties include  KC EMC ,  KC Safety ,  KC Energy Efficiency ,  KC Automotive Components ,  KCsEx (...

Under the amended Act on Resource Circulation of Electrical and Electronic Equipment and Vehicles , the scope of products subject to RoHS will expand from the current 50 items to most electrical and electronic products starting January 1, 2028. All low-voltage electrical and electronic products (AC 1,000V or below, DC 1,500V or below) will, in principle, be subject to RoHS. Products that are difficult to collect or recycle will be listed as RoHS exemptions. The following product categories have been newly added to the exemptions as of the 2028 RoHS expansion announced by the MCEE*: Large fixed industrial equipment and installations Devices recoverable only upon building demolition Machinery for construction, agriculture, and manufacturing Fundamental scientific research instruments Research prototypes and samples Medical devices with infection risks Electrical or electronic parts built into furniture or footwear * MCEE: South Korea’s Ministry of Climate, Energy an...