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Korean MFDS Announces Guidelines for Generative AI-Based Medical Devices

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The Ministry of Food and Drug Safety (MFDS) announced on January 24, 2025 , the publication of the world’s first "Approval and Review Guidelines for Generative AI-Based Medical Devices" . These guidelines are designed to support the safety and efficacy evaluation of medical devices utilizing generative artificial intelligence (AI) technology. For more details, please check the News section on the GCA KOREA website ! 👉 Contact GCA Tel. +82-31-360-8180 Email: forest.lee@gca-kr.com GCA Global Website

KATS 2025 Product Market Surveillance Plan

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South Korea's Korean Agency for Technology and Standards (KATS) has announced its 2025 Product Safety Investigation Plan with key initiatives to strengthen consumer safety and market trust. Key Initiatives: Expansion of Safety Investigations for Overseas Direct Purchase Products Strengthening Safety for Domestically Distributed Products Crackdown on Illegal Products and Strengthening Private Sector Cooperation Enhancing Recall Product Management Learn more about the full plan and how it impacts product compliance on our website! Is Your Product KC Certified? All electrical and electronic products sold in South Korea require KC certification . Ensure compliance with GCA KOREA’s expert services! 📧 forest.lee@gca-kr.com 🌐 Visit GCA KOREA

Korea RRA: USB Type-C Standards to Be Enforced in 2025

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From February 14, 2025 , USB Type-C receptacle connectors will be required for broadcasting and communication devices, including mobile and smart devices . This move seeks to align charging standards and enhance device interoperability. What You Need to Know: Devices Covered : Mobile phones, tablets, laptops, headphones, and other related equipment. Enforcement Timeline : February 14, 2025, for most devices. Laptops must comply by April 1, 2026. 🔎 Looking for More Details? Comprehensive guidance regarding the scope and application methods for conformity assessments can be accessed directly on our website. 🌐 Learn More on Our Website If you have any further questions or need assistance with KC Certification , we encourage you to contact us through our website. 👉 Contact GCA Tel. +82-31-360-8180 Email: forest.lee@gca-kr.com GCA Global Website

China CNCA Updates Wire Assembly Certification Standards

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China Compulsory Certification (CCC) The Certification and Accreditation Administration of China (CNCA) has announced an update to the certification standard for wire assemblies. The revised standard, GB/T 15934-2024 , will replace the previous standards and take effect on October 1, 2025 . To learn more about the changes and their impact, visit our official website: 👉 GCA KOREA Website Stay informed about the latest certification updates! 👉 Contact GCA Tel. +82-31-360-8180 Email: forest.lee@gca-kr.com GCA Global Website

KC Certification Requirements for Vehicle Keyfobs in Korea

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What You Need to Know About Selling Vehicle Keyfobs in Korea Does your Keyfob rely on vehicle power and operate at 433MHz for transmission and 125kHz for reception ? If so, obtaining KC Conformity Certification is essential to comply with Korea's EMC and RF regulations. This certification ensures that your product meets required standards for reliability and compliance in the Korean market. Important: This certification is applicable only to Keyfobs that are powered directly by a vehicle's electrical system. To obtain KC Certification, you must prepare specific documentation and follow the appropriate procedures. → Check out the detailed timeline and the list of required documents for KC Certification. At GCA KOREA , we are experts in facilitating KC Certification for various electrical and electronic products, including vehicle Keyfobs. Our team ensures a smooth and efficient certification process, helping you enter the Korean market with confidence. Partner with GCA KOREA ...

Korean EMC Standards Revised: Effective January 3, 2025

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Exciting updates to the Korean EMC standards have been announced, effective January 3, 2025. Learn about the key revisions and how they might impact your compliance needs. 👉 Read the full article on our website: Korean EMC Standards Updated with Partial Revisions 👉 Contact GCA Tel. +82-31-360-8180 Email: forest.lee@gca-kr.com GCA Global Website

Korea Proposes New Standards for Earth Station Radio Equipment

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The Korean government has announced a proposed amendment to introduce technical standards for earth stations (user terminals) that communicate with low Earth orbit satellites. This move is aimed at ensuring reliable operations in the 11 ~ 14 GHz frequency band, for satellites operating at altitudes of 1,100 km to 1,300 km. What’s Changing? 1️⃣ Defining Operational Parameters The amendment specifies key operational details, such as counterpart space stations and the frequencies required for earth stations. 2️⃣ Strengthening Radio Station Requirements Essential features like satellite tracking and transmission control will be outlined to enhance operational standards. 3️⃣ Protecting Against Interference Transmission and reception parameters for earth stations will be regulated to minimize interference with other radio stations. Why This Matters As the demand for satellite communication grows, especially in low Earth orbit, ensuring a robust regulatory framework is critical. This amendmen...