GCA KOREA (423) 썸네일형 리스트형 123 Medical Products Approved in South Korea in May 2025 South Korea’s Ministry of Food and Drug Safety (MFDS) approved 123 medical products in May 2025, representing 99.2% of the 2024 monthly average (124 products) and 111.8% of the Q1 2025 average (110 products).The breakdown is:37 pharmaceuticals2 quasi-drugs84 medical devicesIn addition, the MFDS approved “Cogthera,” the first domestic digital medical device to help delay cognitive decline in pati.. Non-Sleep Inclined Cradles: Korea Proposes New Safety Category On June 10, 2025, South Korea’s Ministry of Trade, Industry and Energy (MOTIE) announced a proposed amendment to the Enforcement Rules of the Special Act on the Safety of Children’s Products.Under the current regulations, inclined cradles are classified as a type of infant bed. However, safety concerns have emerged after it became known that inclined cradles are not suitable for infant sleep. Th.. RRA Issues Administrative Notice on Proposed Amendment to EMC Test Methods As of 5 June 2025, South Korea's National Radio Research Agency (RRA) has issued a proposed amendment to the Electromagnetic Compatibility (EMC) Test Methods.This amendment reflects Korean Industrial Standards (KS) harmonized with international standards for electromagnetic compatibility and corrects typographical errors in the current EMC test method regulations.Any organization, association, o.. Korea Set to Launch Vehicle Cybersecurity Regulation in August The cybersecurity requirement will take effect on August 14th of this year and apply to vehicles that are manufactured, assembled, or imported since that date. 1. Motor Vehicle Management Act(MVMA) - It is included in the current version2. Enforcement Ordinance of Motor Vehicle Management Act- It is not included in yet the current version but it is expected to publish before August3. Enforcement.. Children’s Swimming Goggles Safety Standards Set for Revision in Korea South Korea’s Ministry of Trade, Industry and Energy (MOTIE) has announced a draft amendment to Annex 4 (Swimming Goggles for Children) under the safety standards for children’s products subject to the Supplier’s Declaration of Conformity.The amendment aims to enhance the regulatory framework by replacing withdrawn standards with updated ones, addressing identified shortcomings in the current sy.. EU Updates Harmonised Standards under the RED On May 14, 2025, the European Commission adopted Implementing Decision (EU) 2025/893, updating the list of harmonised standards under the Radio Equipment Directive (RED). This update ensures that radio equipment in the EU market continues to meet the latest safety, electromagnetic compatibility (EMC), and spectrum efficiency requirements.Key Updates:EN 301 406-2 V3.1.1 - DECT (digital cordless t.. MOLIT Amends EDR Rules in Line with International Standards Korea’s Ministry of Land, Infrastructure and Transport (MOLIT) has amended the regulations to align the recording methods and items of Event Data Recorders (EDRs) with international standards and to clarify the conditions under which recorded driving data must not be overwritten.Under the amendment, EDR data must be preserved if any of the following conditions are met:Deployment of irreversible .. RRA Proposes Revisions to Conformity Assessment Standards for Satellite Radio Equipment On May 21, 2025, Korea's National Radio Research Agency (RRA) announced a revision to the standard to simplify conformity assessment tests for satellite mobile communication radio equipment and to introduce an annex outlining detailed procedures for each test method.The proposed amendment includes:Simplifying environmental condition testing for satellite mobile communication radio equipmentUpdat.. MFDS Launches GMP Support for Korean Medical Device Firms Korea’s Ministry of Food and Drug Safety (MFDS) has introduced a new technical support program to strengthen the quality management systems of domestic medical device manufacturers through the adoption of international Good Manufacturing Practice (GMP) standards.The program, in collaboration with the Daegu Gyeongbuk Advanced Medical Industry Promotion Foundation and the Korea Smart Healthcare As.. Stronger Oversight for EV Charging Facilities Begins in Korea On May 27, 2025, the Korean government hereby enacts the amended Electrical Safety Management Act to establish a systematic framework for EV charging infrastructure. The law introduces the following key measures.Reporting Obligation: EV charging facility operators must report installations and modifications to local authorities to ensure proper supervision.Compulsory Insurance: Operators are req.. 이전 1 2 3 4 ··· 43 다음
