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Usability Data Becomes Mandatory in South Korea’s IVD Regulations

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On September 4, 2025, South Korea’s Ministry of Food and Drug Safety (MFDS) issued an advance notice of partial amendment to the Regulation on the Permission, Notification, and Review of In Vitro Diagnostic Medical Devices . Key Changes Self-testing in vitro diagnostic (IVD) reagents and devices must submit usability data as part of the review documents. Acceptable usability data now includes reports from MFDS-designated institutions, reports from domestic or international professional institutions after testing, and data generated under the manufacturer’s quality management system. Comments may be submitted to MFDS by September 25, 2025. The amended provisions may also be applied to applications submitted before the enforcement date, including approvals, certifications, and technical document reviews. GCA Korea provides expert support for global companies navigating South Korea’s regulatory requirements. Our specialties include  KC EMC ,  KC Safety ,  KC Ener...

Is Your IoT Device Certified? South Korea Highlights IoT Security Certification

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On September 2, 2025, South Korea’s Ministry of Science and ICT (MSIT) highlighted the importance of IoT security certification to strengthen protection for Internet of Things (IoT) products. As robot vacuums, smart refrigerators, IP cameras, and digital door locks become everyday household items, concerns over hacking are growing. IoT security certification, based on Article 48-6 of the Act on Promotion of Information and Communications Network Utilization and Information Protection, verifies compliance with core requirements such as authentication, encryption, software, and network security. To date, around 450 products have been certified, demonstrating stronger protection than uncertified ones. For a safer digital lifestyle, consumers are encouraged to look for IoT security certification, set strong passwords, use official apps, and keep devices updated. GCA Korea provides expert support for global companies navigating South Korea’s regulatory requirements. Our specialt...

Proposed ICT Standards Update from RRA – September 2025

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On September 1, 2025, the National Radio Research Agency (RRA) announced the proposed enactment, revision, and repeal of Information and Communication Technology (ICT) Standards. Enactments (2) KS C IEC 61000-4-41: Electromagnetic compatibility (EMC) – Part 4-41: Testing and measurement techniques – Broadband radiated immunity tests KS C IEC 61000-5-6: Electromagnetic compatibility (EMC) – Part 5-6: Installation and mitigation guidelines – Mitigation of external EM influences Revisions (sample 2 of 8) KS R ISO 11451-1: Road vehicles — Vehicle test methods for electrical disturbances from narrowband radiated electromagnetic energy – Part 1: General principles and terminology KS C IEC 61000-4-12: Electromagnetic compatibility (EMC) – Part 4-12: Testing and measurement techniques – Ring wave immunity test Repeals (2) KS C CISPR 20: Sound and television broadcast receivers and associated equipment – Immunity characteristics – Limits and methods of measurement KS C C...

RRA Announces Amendment to the Conformity Assessment Notification

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Effective immediately. On August 29, 2025, the National Radio Research Agency (RRA) announced an amendment to the Notification on Conformity Assessment of Broadcasting and Communications Equipment . The revision aims to resolve issues identified after the introduction of the Supplier’s Declaration of Conformity (SDoC) system and the reorganization of the equipment classification framework. Key Revisions Improvements to the SDoC system Clearer and updated classification of target equipment 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 (ATEX, IECEx) , or  MFDS (Korean Medical Devices) . For tailored certification and regulatory assistance, contact GCA Korea. We’re here to streamline your market access in South Korea. Contact  ⬇ Tel. +82-31-360-8180 E-mail: forest.lee@gca-kr.com GCA Gl...

South Korea Updates Medical Device Standards and Specifications in Line with IEC/ISO

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On August 27, 2025, South Korea’s Ministry of Food and Drug Safety (MFDS) announced amendments to medical device standards and specifications to align with international standards (IEC, ISO). The revision aims to enhance the safety and quality of medical devices and to prevent potential risks to public health proactively. New standards were introduced for six product categories, including condensation silicone impression materials for dental use and high-intensity focused ultrasound surgical systems. Additionally, testing standards for 17 categories, including anesthesia gas machines and infant incubators, were revised to comply with IEC/ISO requirements. Applications already submitted under the previous regulations will continue to be reviewed according to the former rules. 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 Automot...

Stricter password requirements are going to be implemented for IP cameras

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Stricter password requirements are going to be implemented to image information processing devices(including IP cameras) on Feb. 20, 2026. The password required for image information processing devices shall meet the following conditions: The password shall consist of at least 8 characters using a combination of 3 types among uppercase letters, lowercase letters, numbers, and special characters, or at least 10 characters using a combination of 2 types. If the password is entered incorrectly a certain number of consecutive times (up to 5 times), access shall be blocked for a certain period of time (30 seconds to 60 minutes). 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 (ATEX, IECEx) , or  MFDS (Korean Medical Devices) . For tailored certification and regulatory assistance, contact GCA Korea. We’...

KC Energy Efficiency Management Regulation has been revised and is scheduled to be implemented soon

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For the purpose of achieving energy savings through strengthening item-specific standards and expanding the scope of equipment subject to energy efficiency management as part of improving the energy efficiency management system, the regulation on the operation of energy efficiency management equipment is scheduled to be revised as follows. The following content is scheduled to be implemented soon after collecting public opinions until September 10. Item Key details Expected date of implementation Fan -Expansion of application scope(addition of circulators and BLDC) -Upgrading of efficiency grades and minimum energy performance standards(MEPS) 2027.1.1 Clothes dryer Upgrading of efficiency grades and minimum energy performance standards(MEPS) 2026.10.1 Household gas boiler -Efficiency grades -> minimum standards -Upgrading of minimum energy performance standards (MEPS) 2026.10.1 Air fryer New one of energy efficiency management equipment(efficiency grade) 2027.1.1 Printer New one o...