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.  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...

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...

The MCEE* announced that, under the amended Act on Resource Circulation of Electrical and Electronic Equipment and Vehicles , the obligation to collect and recycle waste products will be expanded to cover all electrical and electronic products starting January 1, 2026. * MCEE: South Korea’s Ministry of Climate, Energy and Environment (formerly: Ministry of Environment) Previously limited to 50 items like TVs and refrigerators, WEEE obligations will expand from January 1, 2026, to cover all electrical and electronic products operating at AC 1,000V or less, or DC 1,500V or less. This includes mid- and small-sized appliances and IT devices such as clothing care systems, portable fans, and Bluetooth earphones. Exemptions apply to certain medical devices, defense products, industrial equipment, and large fixed installations. GCA Korea provides expert support for global companies navigating South Korea’s regulatory requirements. Our specialties include  KC EMC ,  KC Safety ,...

This notification takes effect on October 27, 2025. On October 27, 2025, the Korean Agency for Technology and Standards (KATS) announced the revision of 34 electrical product safety standards, effective immediately. Revised 34 Electrical Appliance Safety Standards KC 60335-2-10  Household and similar electrical appliances － Safety Part 2-10: Particular requirements for floor treatment machines and wet scrubbing machines KC 60335-2-16  Household and similar electrical appliances - Safety - Part 2-16: Particular requirements for food waste disposers KC 60335-2-21  Household and similar electrical appliances - Safety - Part 2-21: Particular requirements for storage water heaters KC 60335-2-24  Household and similar electrical appliances - Safety - Part 2-24: Particular requirements for refrigerating appliances, ice-cream appliances and ice makers KC 60335-2-28  Household and similar electrical appliances - Safety - Part 2-28: Particular...

On October 24, 2025, South Korea’s Ministry of Land, Infrastructure and Transport (MOLIT) announced a legislative pre-notification for the partial amendment to the Regulations for Performance and Safety Standards of Motor Vehicles and Vehicle Parts. The amendment aims to enhance vehicle safety, align domestic standards with international regulations, and improve system efficiency. Key details of the amendment:   Mandatory installation of a pedal misoperation prevention device   Requirement for electric vehicles to display the remaining life of traction batteries   Harmonization of manufacturer logo lighting and bumper safety standards with international regulations   Correction of an error in the test voltage specification for light sources   Expansion of eligible vehicle categories under the length exemption criteria   Comments on this proposal must be submitted to MOLIT by December 23, 2025. GCA Korea provides expert support for global...

On October 22, 2025, South Korea’s Ministry of Food and Drug Safety (MFDS) announced an administrative notice on a partial amendment to the Medical Device Good Manufacturing Practice (GMP). The amendment aims to enhance the rationality and efficiency of the medical device conformity assessment system by introducing a basis for expedited review of life-supporting devices, removing duplicate evaluations in contract manufacturing, and clarifying the scope of on-site inspections. Key Details of the Amendment Establishment of Expedited Review Procedures A framework will allow expedited review of medical devices essential for life support, surgery, or emergency care, as well as newly developed or innovative devices. This is intended to minimize commercialization delays and improve patient access when rapid market supply is needed due to manufacturing or import suspension. Streamlining Review Procedures Between Contracting Parties If a manufacturer already holds a valid conformi...

On October 22, 2025, the Ministry of Food and Drug Safety (MFDS) issued an administrative pre-announcement of the draft amendment to the Regulation on Reporting the Production, Export/Import, and Repair Performance of Medical Devices. The amendment aligns with the enforcement of the Digital Medical Products Act (effective January 24, 2025) and aims to specify reportable digital medical devices and establish new reporting forms suited to their characteristics, improving the efficiency of the reporting system. Specification of digital medical devices subject to reporting and establishment of new reporting forms for digital medical devices Reportable digital medical devices will be clearly defined, excluding standalone software. New forms will enable reporting by product code for more accurate and efficient submissions. Refinement of employee reporting forms Employee reporting forms will be standardized to ensure consistent classification across the food and drug sectors. Establishm...