GCA | Korea KC Mark Certification

  Medical Devices (MFDS) The Ministry of Food and Drug Safety (MFDS) has announced a partial amendment to the Enforcement Rule of the Medical Devices Act.  Public opinions will be collected until July 23, 2024. • The basis for the disclosure of comprehensive plans and implementation plans for medical device safety management will be established. • The reporting procedure will be clarified to allow the manufacturing and import of low-risk Class I medical devices through manufacturing and import notification only. • To clarify the medical device notification acceptance procedure, the acceptance period will be set to 5 days, matching the Class II certification period, and a new form for the notification acceptance certificate (including conditional certificates) will be established. • Clinical trials with minimal risk to participants will be exempt from clinical trial plan approval. • Clinical trials that non-clinical trial institutions can participate in will be defined, and guidelines f

The first trilateral industry ministers' meeting between South Korea, the United States, and Japan was held   On June 26, Minister Ahn Deok-geun of the Ministry of Trade, Industry and Energy held the first trilateral industry ministers' meeting in Washington D.C. with U.S. Commerce Secretary Gina Raimondo and Japanese Minister of Economy, Trade and Industry Saito Ken.   This meeting was a follow-up action to the agreement made by the leaders of South Korea, the United States, and Japan during their summit at Camp David in August last year. The three countries' industry ministers discussed strategies to promote the development of critical and emerging technologies and to strengthen their economic security through their first trilateral conference.   The industry ministers agreed to expand collaboration on semiconductor and critical mineral supply chains, protect advanced technologies through export controls, enhance joint research in AI and other advanced tech, and strengthe

  Marine Radio Devices Technical regulations regarding marine radio devices are planned to be revised in accordance with international standards (ITU/IMO).  Please refer to the details below.  Public opinions will be collected until August 23, 2024. ■ Location Transmitter for Search and Rescue: The regulations on technical standards for search and rescue, which were stricter than international standards, will be relaxed to the level of international standards. ■ Satellite Emergency Position Indicating Radio Beacon (EPIRB): In accordance with international standards, the content is updated to mandate that the Satellite EPIRB be equipped with an Automatic Identification System (AIS) function. ■ Onboard Communication Station: Analog transmitters using a channel spacing of 25 kHz are specified to have an occupied bandwidth of 16 kHz, and analog transmitters using a channel spacing of 12.5 kHz are specified to have an occupied bandwidth of 8.5 kHz. ■ Autonomous Maritime Radio Equipment: To

Second General Meeting of the Industrial Artificial Intelligence International Certification Forum Held   South Korea can now issue industrial AI certifications based on international standards. Hyundai Autoever was the first to receive this certification on June 25 for its AI-driven smart vision technology for detecting surface defects, marking a milestone with the country's first international-standard AI test report.   The Ministry of Trade, Industry and Energy announced that the second general meeting of the 'Industrial Artificial Intelligence International Certification Forum' was held on June 25 in Seoul. Since its founding in June 2023, the forum has designated accredited testing labs for six international standards related to AI to boost the export competitiveness of AI products and services. This initiative has led to the recent issuance of certifications.   Additionally, during the general meeting, a Memorandum of Understanding (MOU) was signed to expa

  Federal Communication Commission (FCC, US) On June 12, 2024, the Wireless Telecommunications Bureau (WTB) and the Office of Engineering and Technology (OET) of the Federal Communications Commission (FCC) issued a public notice allowing certified Spectrum Access System (SAS) administrators to modify the aggregate interference model used to regulate Citizens Broadband Radio Service (CBRS) operations in the 3.55-3.7 GHz (3.5 GHz) band. The public notice can be viewed here . 👉 Contact GCA Tel. +82-31-360-8180 Email: forest.lee@gca-kr.com GCA Global Website

Changes to the conformity assessment of targeted equipment scheduled for June 30   The changes to the conformity assessment of targeted equipment are due to the implementation of the revised "Notification on Conformity Assessment of Broadcasting and Telecommunication Equipment," which was amended in December 2023 and is set to take effect on June 30, 2024.   1.      Items moving from non-targeted to targeted for conformity assessment Targeted equipment Types of Conformity Assessment Laser welders and cutters Registered with designated testing agency LiDAR lamps Scalp LED helmets Registered with designated testing agency (Self-registration for models operating on USB or battery power) Tufting guns Automatic can sealers Laser engravers Laser marking coders Hot air shrinkers Self-test registration DC powered pr

Government and industry unite to drive growth in the EV battery service sector   Electric vehicle (EV) battery services cover the entire lifecycle of a battery, from installation to recycling, generating added value through charging, maintenance, and more. As the global adoption of EVs increases, this emerging industry is gaining attention. Reflecting this potential, on June 18th, South Korea's ministries responsible for trade, transportation, and the environment co-hosted a meeting to promote the EV battery service industry.   At the meeting, the industry presented eight promising service models that it had selected. These include subscription services and financial services aimed at reducing the cost burden of purchasing electric vehicles, performance diagnostic services designed to extend the life and safety of batteries, and services that generate additional revenue through carbon credit trading and power trading using EV batteries.   A "Public-Private Joint Co

  Electric Scooter Use of KC Certified Electric Scooters According to the National Fire Information System's fire statistics, there have been 467 electric scooter fires in the past five years, with the number increasing each year, necessitating caution. There were 175 incidents in the summer (June to August), the highest among the seasons, followed by 118 in autumn, 99 in spring, and 75 in winter, making summer fire incidents more than twice those in winter. Especially in summer, the rising temperatures can cause the battery of electric scooters to overheat suddenly, significantly increasing the risk of fire, so extra caution is required. To prevent electric scooter fires, it is crucial to use products that have been certified for safety, such as those with KC certification. Additionally, avoid storing the scooter in high-temperature locations for extended periods, unplug the power cord immediately after charging is complete, and refrain from making unauthorized modifications to in

The selection process for the top 10 leading projects in AI Autonomous Manufacturing has begun   South Korea's Ministry of Trade, Industry, and Energy has begun implementing the AI Autonomous Manufacturing initiative, aiming to enhance key industries by integrating AI-based robotics into manufacturing processes. This effort follows the recent announcement of the "AI Autonomous Manufacturing Strategy 1.0" and the initiation of the selection process for top projects under this strategy.   After announcing the "AI Autonomous Manufacturing Strategy 1.0," South Korea's Ministry of Trade, Industry, and Energy identified over 40 potential projects through surveys and meetings. They began an official demand survey on June 5 and plan to finalize the top 10 projects by August. Additionally, an AI Autonomous Manufacturing Alliance will be launched in July to reveal the list of candidate projects.   The Ministry of Trade, Industry, and Energy in South Korea

  Custom Cosmetics The Ministry of Food and Drug Safety (MFDS) has revised the "Regulations on Reporting Production and Import Performance and Ingredient Lists of Cosmetics" to allow for the reporting of ingredient lists by product group for various customized cosmetics. The revision was announced on June 14. Custom cosmetics sellers are required to report the ingredient lists of custom cosmetics to the MFDS once a year. Custom cosmetics are defined as those where ingredients specified by the MFDS are added or mixed with the base material, considering individual skin characteristics and personal preferences, or where the contents are subdivided. This can result in numerous products depending on the use of various ingredients. Through this revision, custom cosmetics sellers can now report the ingredient lists of custom cosmetics by grouping them into one product category if the base material is the same, even if the product names differ. Previously, they had to report the ingr

Proposed Ordinance to Amend Part of the Enforcement Rules of the Electrical Appliances and Household Products Safety Management Act   Portable ethanol stoves are currently not included in the safety management items regulated under the existing Electrical Appliances and Household Products Safety Management Act, meaning they are distributed without specific safety standards applied. Given the product's susceptibility to fire accidents and the ongoing safety incidents, there are plans to establish safety standards for these products to ensure consumer safety.   The "portable ethanol stove" item will be added to the list of household products that must comply with safety standards.   Comments can be submitted to the relevant authorities until August 14, 2024. 👉 Contact GCA Tel. +82-31-360-8180 Email: forest.lee@gca-kr.com GCA Global Website

  Pharmaceutical Approval and Review The Ministry of Food and Drug Safety announced the pilot operation of a new "Pharmaceutical Approval and Review Coordination Committee," which allows applicants to request adjustments when supplementary documentation is required during the pharmaceutical approval and review process. Documents eligible for coordination requests are those related to safety and efficacy review, quality review, and data protection status. The Ministry of Food and Drug Safety will select the agenda items for the coordination committee meetings after a preliminary review. However, cases where regulations are clear or where advice from the Central Pharmaceutical Affairs Council has been sought or deemed necessary are excluded from the preliminary review process. This coordination committee has been newly established to ensure greater transparency in the pharmaceutical product approval and review process. After a one-year trial period, a decision will be made on w

The 12th Korea-European Union Free Trade Agreement Goods Trade Committee was held   On June 12, the Ministry of Trade, Industry and Energy, and the Ministry of Food and Drug Safety of South Korea held a meeting with the European Union in Brussels to discuss the Free Trade Agreement. The Goods Trade Committee discussed tariff and non-tariff issues, reviewed the Korea-EU Free Trade Agreement's implementation, and explored solutions for market entry challenges faced by businesses from both regions.   At the meeting, South Korea highlighted the difficulties faced by Korean companies due to the EU's stringent environmental regulations, including the Battery Directive, Carbon Border Adjustment Mechanism, and Forest Conversion Prevention Law. This refers to regulations and laws designed to prevent the . The South Korean side emphasized the need for clearer regulations, recognition of diverse carbon reduction efforts, and improvements to reporting systems. They also discussed the EU

  South Korea and Nigeria signed a MOU The Ministry of Food and Drug Safety announced that, on the occasion of the Korea-Africa Summit, the Korea Ministry of Food and Drug Safety and the Nigerian Food and Drug Administration have signed a Memorandum of Understanding (MOU) to strengthen mutual cooperation in the field of medical products on the 7th. This Memorandum of Understanding (MOU) was established to promote cooperation and the exchange of technical knowledge regarding the safety of medical products. Both sides have agreed to promote the exchange of information on laws, regulatory systems, knowledge, and regulatory experiences in the field of medical products. They will also conduct regular meetings and exchange visits, provide education and consultation for regulatory agencies and industry, and cooperate to simplify the approval procedures for Korean medical products. 👉 Contact GCA Tel. +82-31-360-8180 Email: forest.lee@gca-kr.com GCA Global Website

South Korea is set to build its first 8-inch power semiconductor fab   South Korea's first 8-inch power semiconductor fab will be constructed in Busan, marking the initial investment following April's announcement of specialized support measures. This new 8-inch fab will increase productivity by approximately 1.8 times compared to the existing 6-inch versions.   On June 5th, Kang Kyung-sung, the First Vice Minister of Trade, Industry, and Energy, attended the groundbreaking ceremony for IQ Lab's new facility in the Busan Power Semiconductor Specialized Complex. IQ Lab is investing 100 billion won to build an 8-inch semiconductor factory for electric vehicles and plans to relocate its headquarters from the Seoul metropolitan area to Busan, aiming to become a comprehensive power semiconductor company.   Since its designation in July 2023, the Busan specialized complex for 8-inch factories has seen its total investment grow to 1.2 trillion won due to new commitment

  Circular Resource Utilization Product Labeling The "Circular Resource Utilization Product Labeling System" is a system that allows products using a certain percentage of quality-certified circular resources to be labeled as circular resource utilization products. Only products that have been confirmed to use 10% or more of quality-certified circular resources, based on the weight of the raw materials used in the manufacturing process per product, can be labeled as circular resource utilization products. Products that have been certified as circular resource utilization products can display the label "Circular Resource Utilization Product, Ministry of Environment" on their packaging or containers. This allows consumers to easily identify products that contribute to resource circulation, and it is expected to help companies promote their products. Korea Certification - EcoAS (K-RoHS | Recycling | K-WEEE) 👉 Contact GCA Tel. +82-31-360-8180 Email: forest.lee@gca-kr.c

  Korea-Indonesia MRA Signing The Ministry of Science and ICT announced on May 27, 2024, that it had signed Phase 1 of the Mutual Recognition Agreement (MRA) for Electromagnetic Compatibility (EMC) evaluation with Indonesia. This MRA was signed to alleviate the inconveniences and cost burdens faced by Korean ICT companies when exporting. With this agreement, companies can use the conformity assessment test reports obtained domestically to receive certification from the Indonesian government, enabling them to export immediately. This will shorten the product launch period and reduce testing costs by approximately 65%, thereby enhancing global competitiveness. Currently, Korea has signed Phase 1 MRAs with 31 countries, including the United States, Vietnam, Chile, the United Kingdom, and the EU (27 countries). Additionally, Korea has signed a Phase 2 MRA with Canada. ※ Mutual Recognition of KC Certification and CE, FCC Certification 👉 Contact GCA Tel. +82-31-360-8180 Email: forest.lee@gc

Administrative Notice of Partial Amendment of Efficiency Management Equipment Operation Regulations   The Ministry of Trade, Industry and Energy has issued an administrative notice of partial amendments to the Efficiency Management Equipment Operation Regulations.   -Television receivers: reset efficiency rating criteria due to changes in KS standard consumption efficiency measurement method and expanded coverage due to increased penetration of large-screen, high-definition models -Electric refrigerators: Reflected the resetting of efficiency rating criteria and the time required for retesting the reported model due to the planned change in the KS standard consumption efficiency measurement method. -Electric cooling and heating equipment: integrated maintenance of electric cooling and heating equipment (integration of air conditioners, air conditioners, EHPs into air conditioners, air conditioners, and EHPs), establishment of technical standards for consumption efficiency, and unificat

  MFDS Sanitary Products The Ministry of Food and Drug Safety (MFDS) announced on May 31 that it will accept public comments until July 15 on the proposed amendments to the Enforcement Rules of the Act on Testing and Inspection in the Field of Food and Drugs, which include expanding the designation of overseas testing and inspection agencies to cover sanitary products. To facilitate the convenience of importers of sanitary products, the designation of overseas testing and inspection agencies has been expanded to include sanitary products. By submitting test reports from overseas testing and inspection agencies designated under the Food and Drug Testing Act when importing sanitary products, import inspections for domestic customs clearance can be waived. Additionally, provisions have been made to issue the designation certificates for testing and inspection agencies online, which were previously issued only as paper documents. Furthermore, when submitting an application for the designat