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  The Ministry of Food and Drug Safety (MFDS) has announced a proposed amendment to regulations on pharmaceutical safety on November 29 to facilitate regulatory innovation in the pharmaceutical field. This draft is open for public opinion until January 28 next year. ● The key contents of the amendment proposal 1. When applying for a manufacturing permit for products under full-process outsourcing, exempt the submission of pharmaceutical manufacturing and quality management standards evaluation data, and allow the substitution of some documents with a statement of reasons when applying for approval for essential national medicines with no alternative. 2. Clearly specify the submission of necessary data for approval during the approval of the clinical trial plan. 3. Improve the reporting deadline for drug supply discontinuation from the current 60 days to 180 days in advance, require reporting even in the case of shortages, and strengthen administrative sanctions for failure to report. 4

  'System standardization' aims to develop standards ensuring interoperability across entire systems or between systems, departing from the traditional focus on individual components. On November 30, the National Institute of Technology Standards held a forum to share achievements in system standardization in areas such as 'AI speakers for the elderly' and 'low-voltage direct current distribution' among domestic companies. Notably, development requirements for services like medication time alerts in AI speakers for the elderly and safety guidelines for household low-voltage direct current distribution have been proposed as international standards (IEC) and are currently in progress.   At the forum, the Korea Electronics Technology Institute shared guidelines and programs developed through the National Standard Technology Enhancement Project for the system standard development approach. They also presented practical interoperability cases in low-voltage direct c

  The plan for the development of Energy Storage System (ESS) to supplement volatility and ensure stable operation of the power system, in response to the expansion of renewable energy, is expected to be pursued expeditiously. The Ministry of Trade, Industry, and Energy held the first Energy Storage System (ESS) Industry Development Council on November 24th. The council is organized into four subcommittees: technology development, market mechanisms, industry promotion, and export support. Experts in each field, as well as representatives from energy public agencies and financial institutions, will participate in implementing a flexible power system. The plan is to review the progress and performance in achieving the goals outlined in the Energy Storage System (ESS) Industry Development Strategy announced last October, which aims to achieve a 35% market share in the global ESS market by 2036. At the meeting on that day, various approaches to Energy Storage System (ESS) technology develo

  Samsung Electronics plans to incorporate AI technology into smartphones, laptops, and other products starting next year. Samsung Electronics is expected to apply on-device AI technology using its internally developed generative AI model, "Samsung Gauss," to new laptops. Samsung Gauss is the next-generation generative AI capable of performing three functions: language and code, as well as image generation. On-device AI refers to AI operations that mostly run on the device itself, closely connected to the user, and only occasionally connect to the cloud when necessary. This allows consumers to use features like device control, sentence summarization, and grammar correction more easily and conveniently without the need for transmitting personal information.   Samsung Electronics is currently conducting beta tests for Samsung Gauss internally and plans to gradually expand it to the general consumers. 👉 Contact GCA Tel. +82-31-360-8180 Email: forest.lee@gca-kr.com GCA

  The Ministry of Environment will hold the first meeting in Seoul on November 27th after the launch of the 'Electric Vehicle Charging Alliance.'   This alliance includes 76 companies engaged in the production and operation of charging stations, accounting for 96.1% of the nationwide charging stations. Additionally, government bodies, academia, research institutions, and industry representatives have participated in the alliance. The meeting will cover topics like enhancing charging station certification, supporting exports, preventing electric vehicle fires during charging, improving key component quality, and exploring regulatory enhancements to support the industry. The goal is to share insights and collaborate on industry support.   Additionally, the meeting will address the composition and operational direction of the alliance, along with recent suggestions from charging operators and electric vehicle users regarding charging facilities. If you need information

  The National Institute of Technology Standards under the Ministry of Trade, Industry, and Energy launched the "Semiconductor Standardization Forum" on November 24 in Pangyo, with the participation of over 50 semiconductor standard experts from companies such as Samsung Electronics and SK hynix.   Sejong University Professor Kim Deok-gi presented developments in three new international standards related to the performance and reliability verification of neuromorphic devices, which aim to mimic the information processing methods of neurons in the human brain using semiconductor technology. Neuromorphic devices represent a next-generation semiconductor technology designed to perform advanced cognitive functions in artificial intelligence by emulating the information processing methods of neurons in our brains. These standards were developed through the National Standard Technology Enhancement Project and were adopted as new development items by the International Electro

  LG Electronics is entering the U.S. electric vehicle charger market with a lineup of slow and fast chargers. In the first half of next year, they plan to release a slow charger with a charging capacity of 11 kW and a fast charger with a charging capacity of 175 kW in the United States. The slow charger is characterized by its flexible space utilization, such as wall mounting or standing freely. It is also equipped with a load management solution that automatically controls the output based on the power situation in commercial spaces like shopping malls and supermarkets where chargers are installed. This ensures a stable charging service even with limited power capacity. The fast charger supports both CCS1 (Combined Charging System) and NACS (North American Charging Standard) charging methods simultaneously. It provides a convenient charging experience through a touch display and offers additional revenue opportunities through advertising. LG Electronics plans to expand its lineup of

  On the 21st, the Hyundai Motor Group announced the official opening of the 'Hyundai Motor Group Singapore Global Innovation Center (HMGICS)' in the Jurong Innovation District in western Singapore.   The Hyundai Motor Group considered Singapore, with its open policies, strong economy, excellent infrastructure, and talented workforce, as the optimal location for a human-centric 'smart urban mobility hub.' 양식의 맨 위 Hyundai Motor Group has implemented advanced technologies such as artificial intelligence (AI) and robotics in HMGICS, establishing a highly automated cell-based flexible production system, efficient production operations based on digital twin technology synchronizing the real and virtual worlds, a data-driven intelligent operational system, and a human-centric manufacturing process where humans and robots harmonize.   Additionally, Hyundai Motor Group emphasizes customer-centricity in the future of mobility innovation. They aim to provide tailored

  The Ministry of Science and ICT will accept applications for the allocation of 28GHz frequencies for new business operators in the 5G sector from November 20 to December 19. The allocation target for 28GHz is the 800MHz band, ranging from 26.5GHz to 27.3GHz. Additionally, a total bandwidth of 20MHz, specifically 738MHz to 748MHz and 793MHz to 803MHz, is also subject to allocation in the anchor frequency 700MHz band. The government has allowed new business operators to have various options and lowered the market entry barrier by permitting both nationwide and regional allocation applications simultaneously. For the obligation of network construction corresponding to the allocation conditions, businesses receiving allocations are required to deploy a total of 6,000 28GHz base station equipment nationwide by the third year from the allocation date. The Ministry of Science and ICT stated that if new business operators focus their investments on the 28GHz band and contribute to ecosystem

The revised Intelligent Robot Act, which came into effect on November 17, 2023, is expected to lead to an increasing encounter with robots delivering food or goods while walking on sidewalks. For the safety of pedestrians, robots allowed to move on sidewalks are restricted to a weight of 500 kg or less and a width of 80 cm or less. The speed of movement is regulated to be 5-15 km/h depending on the weight. To operate a business using robots, it is necessary to obtain operational safety certification from a designated certification authority. The certification authority will issue a safety certification, similar to a 'pedestrian license,' certifying the safe operation of the robot, after evaluating 16 criteria, including compliance with operational zones, pedestrian crossing, dynamic stability, speed control, and remote operation. Furthermore, the robot must comply with traffic laws, and in the case of jaywalking or violation of safety regulations, the operator may be subject to

  The Ministry of Trade, Industry, and Energy, along with the National Standards Committee, will host the "ISO Leadership Development Program" from November 20 to 24 in Seoul. The program will bring together over 20 high-ranking representatives from standardization bodies in 12 countries across the Asia-Pacific and Middle East regions, including Saudi Arabia, Indonesia, and Singapore. As part of the commitment made during the International Organization for Standardization (ISO) annual meeting in September this year, the "ISO Development Country Action Plan" is a program designed to support the increased participation and utilization of international standards by developing countries. It includes initiatives such as technical assistance, education, and training. ISO's support for developing countries is a key policy led by President Cho Seong-hwan. South Korea, having joined the ISO Council in September, plans to assist developing countries in expanding the

  The Ministry of Trade, Industry, and Energy convened a meeting on November 16 with key players in the battery industry, including the Battery Association, Samsung SDI, LG Energy Solution, and SK On, to discuss major trade issues.   The United States released provisional guidelines in March for tax credits under the "Inflation Reduction Act," including criteria for environmentally friendly car batteries. The final guidelines are expected to be announced later this year, with plans to continue discussions   between the government and U.S. authorities to address remaining issues and ensure smooth tax credit receipt for our companies.   The EU is working on regulations for the Battery Act introduced in August, and the Korean government is assessing the readiness of local companies for new environmental rules related to battery carbon footprint and mandatory use of recycled materials.   China announced export control measures on graphite last month, prompting the Sou

  The MFDS (Ministry of Food and Drug Safety) has released and distributed the 'Medical Device GMP Evaluation Casebook,' containing actual cases of conformity assessment examinations for medical device manufacturing and quality management standards, on November 15th. This casebook is structured to assist the industry in preparing for and responding to medical device GMP conformity assessment examinations, covering criteria for selecting items subject to evaluation, considerations for assessing contract manufacturing facilities, necessary documentation for products sterilized by end-users, and criteria for selecting manufacturing facilities for on-site inspections. It is worth noting that this casebook compiles discussions between the MFDS and quality management inspection agencies, categorized by case and stage, from the application for evaluation to the issuance of the compliance certificate. It also consolidates frequently asked questions from the industry regarding GMP confo

  KC Certification - EcoAS  |  K-RoHS | Recycling | K-WEEE This is a program intended to promote the closed-loop recycling of electrical and electronic products and vehicles and minimize environmental loads by managing the entire lifecycle of products from design and production to disposal. The process includes restricting the use of hazardous substances, increasing the ease of recycling, and recycling waste substances. ▮ Products subject to certification Products that require post-management 50 items including refrigerator, electric water purifier, air conditioner, dehumidifier, TV, computer, monitor, printer, scanner, wired/wireless router, cellphone, washing machine, microwave, humidifier, iron, toaster, and coffee maker Products that require pre-management 49 items including refrigerator, electric water purifier, air conditioner, dehumidifier, TV, computer, monitor, printer, scanner, wired/wireless router, cellphone, was

  The Ministry of Trade, Industry and Energy held a meeting on November 16 at the Seongil Hi-Tech Gunsan Plant for companies participating in the pilot project for the recycled material certification system.   EU and other advanced nations are promoting mandatory regulations on the use of recycled materials, particularly for batteries and plastic products. This is expected to significantly increase the demand for certification of recycled material usage among South Korean export companies. However, the absence of a domestic certification system has led businesses to rely on foreign certifications.   The Ministry of Trade, Industry, and Energy is developing a certification system to trace the use of recycled materials from raw materials to final products. The pilot project, initiated this year, involves five products, including battery materials and home appliances like refrigerators, TVs, washing machines, and soundbars.   The Ministry of Trade, Industry, and Energy aims to

  SK Eco Plant succeeded in internalized key technologies, including high recovery rates for nickel, cobalt, and lithium, waste reduction in effluents, and fire prevention in high-speed discharging, across the entire process of recycling and post-processing used batteries.   SK Eco Plant achieves a 97% recovery rate for rare metals nickel and cobalt using a solvent extraction method from used batteries. The purity of the recovered nickel and cobalt reaches 99.9%, equivalent to mineral levels used in battery manufacturing.   SK Eco Plant achieves a 90% recovery rate for lithium, a key rare metal used in battery cathodes. The company optimizes the recovery process using a solvent extraction method, deviating from the conventional dry process, and integrates technology to produce lithium hydroxide used in batteries.   SK Eco Plant has advanced its technology for the discharge of used batteries. Typically, it takes about a day to fully discharge spent batteries, but through col

  The National Radio Research Agency, known as RRA, and the Korea Radio Promotion Association, referred to as RAPA, jointly organized the 2023 Global Wireless Power Transfer Conference on November 14. This conference is an annual event held to enhance information exchange and foster communication and collaboration among domestic and international stakeholders in the latest wireless power transfer technologies, services, standardization, regulations, and related areas. Wireless power transfer technology is gaining attention as a next-generation innovation in wireless technology, allowing the transmission of electric energy in space without the need for wires. This technology is recognized for its freedom and convenience compared to traditional wiring, and it is expanding into various fields such as mobile phones, electric vehicles, robots, wireless charging for medical devices, contributing to the emergence and growth of a new digital economy. At this conference, three sessions were hel

  Battery Consortium Submits Proposal for Used Battery Management System and Legislation The battery consortium involving three major battery manufacturers and Hyundai Motor submitted a 'Integrated Management System for Used Batteries' proposal and supporting legislation to the government on November 14.   The industry proposal redefines used batteries as those separated from electric vehicles and designated for remanufacturing, reuse, and recycling.   The industry proposal focuses on allowing various transactions while ensuring fairness and efficiency. It sets minimum qualifications for those dealing with used batteries and requires recording all transaction outcomes in the government system.   Businesses handling batteries must input comprehensive information into the system throughout the battery's life cycle.   The industry proposal suggests a three-step inspection system, including pre-utilization inspection, product safety inspection, and post-inspecti

  Apple to Bring OLED to iPad Pro Models Apple plans to equip OLED panels on the 11-inch and 12.9-inch iPad Pro models, set to be released in the second quarter of next year.   LG Display is reported to have received orders from Apple for 60% of the 10 million OLED panels intended for the iPad. LG Display plans to commence the initial production of iPads at its G6 line in Paju City in the first quarter of next year (January to March). Apple's adoption of OLED displays is expected to expand gradually, starting with the iPhone 15. Apple is also reportedly pushing for the incorporation of OLED screens in MacBook models and foldable iPad models scheduled for release in 2026. With Apple incorporating OLED panels into tablets and notebooks, it is anticipated that the IT OLED market will rapidly expand. This move by Apple may also lead to other competitors significantly expanding their OLED product offerings. If you need information or have inquiries related to testing and certi

  South Korea Speeds Up Domestication of Advanced HVDC Technology The Ministry of Trade, Industry and Energy announced that it will hold the 'Domestication of Voltage-Type Ultra-High-Voltage Direct Current (HVDC) Transmission Technology Development Achievement Presentation' on November 10.   HVDC transmission utilizes the ultra-high-voltage direct current method, offering advantages such as long-distance, high-capacity transmission, power flow control, and the absence of electromagnetic waves compared to traditional alternating current transmission. South Korea accelerates domestication of advanced Voltage Source Converter-based Ultra-High-Voltage Direct Current (VSC-HVDC) technology, known for real-time bidirectional power flow control and grid stability advantages.   Korea plans to achieve domestication of VSC-HVDC technology by March 2024 after conducting performance evaluations on the actual grid through the Yangju Converter Station testbed. If you need informatio

  Hyundai's Supernal plans to build an electric flying taxi factory in the United States Supernal CEO announced in an interview with Bloomberg on the 7th (local time) that the prototype of the electric vertical takeoff and landing aircraft (eVTOL) will be unveiled at the International Consumer Electronics Show (CES) in Las Vegas in January next year.   The eVTOL can fly at a speed of 120 miles per hour (approximately 190 km/h) and accommodate one pilot and four passengers. Supernal plans to conduct test flights in December next year, with the goal of commencing commercial service four years later.   Supernal intends to submit an application to the FAA for eVTOL certification in the coming months, aiming to navigate through the uncharted territory of regulations and policies in this innovative field. The new CEO envisions that initially, eVTOL taxis and similar air mobility options will be limited to "very advanced cities." However, as the public becomes more co

The Ministry of Science and ICT has announced a postponement of the usage period for analog consumer radios operating in the 400MHz band until December 31, 2026. In 2015, the Ministry of Science and ICT announced plans for a rapid digital transition by introducing superior digital consumer radios in aspects such as frequency utilization efficiency, communication quality, and security. As part of this initiative, analog consumer radios were slated to conclude certification by December 31, 2018, and the usage was planned to be discontinued by the end of this year. However, consumer radios, being unlicensed devices that can be used without permits or registration, continued to be sold after the certification expired in 2018. Consumers who were unaware of the discontinuation of use have been requesting an extension of the usage period. In response, the Ministry of Science and ICT conducted a review of consumer awareness regarding the discontinuation of analog consumer radios and considered