Korea KC Certification | GCA

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...

On September 22, 2025, the Korean Agency for Technology and Standards (KATS) issued an administrative notice regarding the revision proposal of the Safety Standards for Consumer Products Subject to Compliance - Appendix 16 (High-visibility warning jackets) . This revision addresses deficiencies identified during the current system's operation by replacing outdated standards with more appropriate, up-to-date ones. Key revision details Replacing abolished related standards with current appropriate standards: KS A 3507 KS T 3507: Standard specification for retroreflective sheeting for traffic control & industrial safety KS K ISO 105-C02 KS K ISO 105-C06: Textiles — Tests for colour fastness — Part C06: Colour fastness to domestic and commercial laundering Individuals, companies, or organizations wishing to provide feedback on the proposal may submit comments to KATS by October 20, 2025. GCA Korea provides expert support for global companies navigating South Korea’s...