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Real-World Data Collection for High-Risk Implantable Medical Devices Now Allowed in South Korea

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The amended Enforcement Decree of the Medical Device Act took effect upon promulgation on July 22, 2025. Provisions related to processing personal information will come into force on August 1, 2025. The amendment provides a legal basis for Korea’s Minister of Food and Drug Safety (MFDS) and local governments to process sensitive and personally identifiable information when necessary to collect, analyze, and evaluate real-world data generated during the use of certain medical devices. This change follows a revision to the Medical Device Act that enables the designation of devices requiring long-term follow-up due to frequent or serious adverse effects after insertion into the human body. Personal information may also be processed when responding to adverse events, including reporting, recall, and notification involving patients who have used the relevant devices. For any inquiries regarding medical device certification in South Korea, don’t hesitate to reach out to GCA KOREA. O...
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New Maritime Radio Rules Now in Effect in South Korea

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On June 23, 2025, South Korea’s National Radio Research Agency (RRA) issued a notification revising the technical standards for maritime radio equipment. This amendment aims to enhance maritime safety by eliminating outdated provisions and harmonizing Korea’s standards with international regulations. The revision took effect immediately, and equipment certified or authorized under previous rules remains valid. Key Highlights: Relaxed SAR Transmitter Requirements:  Technical requirements for Search and Rescue (SAR) location transmitters have been eased and clarified with diagrams, aligning them with international standards. EPIRB AIS Support Mandated: Satellite Emergency Position-Indicating Radio Beacons (EPIRBs) are now required to support the Automatic Identification System (AIS). Clear Occupied Bandwidth Specifications for Ship Stations: Occupied bandwidths are now clearly defined as 16   kHz for 25   kHz channel spacing and 8.5   kHz for 12.5   kHz spacing. ITU Compliance fo...
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Child-Resistant Packaging Mandated for Coin Batteries in South Korea

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On July 16, 2025, the Korean Agency for Technology and Standards (KATS) announced a proposed amendment to the Operational Guidelines for Safety Management of Electrical Appliances and Consumer Products. The revision aims to classify button- and coin-type primary batteries as products that require child-resistant packaging (CRP) and to update the criteria for CRP registration number assignment. These batteries are widely used in everyday products such as toys, remote controls, and small electronics. However, if swallowed by children, they can cause severe internal injuries—including burns, perforations, and ulcers—due to electrochemical reactions within the body. In serious cases, failure to remove the battery promptly can be fatal. In the United States, a tragic incident in 2020 involving 18-month-old Reese Hamsmith, who swallowed a coin battery, led to the enactment of Reese’s Law. Starting in March 2024, the law implements stricter packaging and labeling requirements for these ba...
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New Safety Criteria Proposed in South Korea for Electrical Products

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On July 15, 2025, the Korean Agency for Technology and Standards (KATS) issued an administrative notice announcing a proposed revision to the Criteria for Handling Nonconformities with Electrical Appliance Safety Standards. The revision aims to align the standards with international practices. The proposed changes specify procedures for handling nonconformities and update the list of regulated items. Notably, due to changes in product category names, the item “Accessories and Connectors for Electric Vehicles” will be removed and replaced with a new category, “Automobile Adapter.” Stakeholders, including individuals, companies, or organizations, may submit their comments on the proposed revision to KATS by September 14, 2025. We’re your go-to team for KC certification in South Korea. At GCA KOREA, we support global manufacturers through every step of the certification process, from paperwork to testing, so that you can enter the Korean market with confidence. Our goal is to m...
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New EMC Testing Standards Now in Effect in South Korea

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On July 11, 2025, South Korea’s National Radio Research Agency (RRA) revised the country’s electromagnetic compatibility (EMC) testing methods to incorporate updates to national standards (KS) and correct minor typographical errors and inaccuracies. The revision improves alignment with international standards and provides greater clarity in regulatory application. The updated methods adopt newly revised KS standards for various categories of wireless and electrical equipment. Key examples include: KS X 3124:2024: Common technical requirements KS X 3126:2024: Specific conditions for Broadband Data Transmission Systems KS X 3128:2024: Specific conditions for Digital Enhanced Cordless Telecommunications (DECT) equipment KS B ISO 8102-1:2020: Electrical requirements for lifts, escalators and moving walks — Part 1: Electromagnetic compatibility with regard to emission KS C IEC 60947-1:2014 / KS C IEC 60947-2:2019 / KS C IEC 60947-4-1:2018: Low-voltage switchgear and controlgear ...
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Automotive Software Updates Must Now Be Reported in South Korea

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On July 9, 2025, South Korea’s Ministry of Land, Infrastructure and Transport (MOLIT) announced a proposed regulation requiring automakers to submit documentation verifying compliance with safety and cybersecurity standards when performing software updates. This reflects the ongoing shift toward software-driven vehicle technologies and the increasing integration of communication-based connectivity between vehicles and external systems, alongside the growing need to address cybersecurity risks. Under the amended Automobile Management Act, effective August 14, 2025, vehicle manufacturers and related entities must provide evidence that their software updates meet applicable requirements. The regulation outlines five key categories of documentation: Inter-System Impact and Update Verification: Documentation of interactions with other systems and assessment of functional changes Compliance with Safety Standards: Confirmation of software and hardware configurations, and evaluation of...
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3-Year Certificate System for Automotive Cybersecurity Introduced in South Korea

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On July 9, 2025, South Korea’s Ministry of Land, Infrastructure and Transport (MOLIT) released an administrative preannouncement introducing a new automotive cybersecurity certification system. The system responds to the growing risks of cyberattacks as vehicle technologies shift to software-based systems and external connectivity becomes more widespread. The proposed rules include requirements for pre-submission documents, audit procedures, certificate issuance and reissuance, and the submission of data after certification to ensure compliance and oversight. Key Highlights Application Process: Requirements for documentation, facility readiness, and certification updates Certification Criteria: Standards for cybersecurity management systems Audit and Appeals: Procedures for document review, on-site audits, and appeals Certificate Management: Issuance, renewal, and return rules with 3-year validity Post-Certification Oversight: Ongoing incident reporting and response requi...
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