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