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Showing posts with the label ConformityAssessment

Korea MSIT to Enforce USB-C Requirement for Mobile Devices Starting in 2026

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On November 5, 2025, the MSIT* issued a notification that the Technical Standards for Charging and Data Transmission Methods for mobile and smart devices, originally scheduled to start in February 2025 but delayed, will take effect on November 6, 2026. As previously announced in 2024: The standards apply to mobile and smart devices that support wired charging or both wired charging and data transfer. Products within scope must be equipped with USB Type-C receptacle connectors compliant with the relevant specification, which will be added to the Supplier’s Declaration of Conformity (SDoC) target items under KC EMC once the standards take effect. Covered devices include mobile phones, tablets, digital cameras, headphones, headsets, handheld game consoles, portable speakers, e-book readers, keyboards, mice, portable navigation devices, earphones, and laptops. * MSIT: the Ministry of Science and ICT in Korea GCA Korea provides expert support for global companies navigating ...

South Korea Updates Medical Device Good Manufacturing Practice

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On October 22, 2025, South Korea’s Ministry of Food and Drug Safety (MFDS) announced an administrative notice on a partial amendment to the Medical Device Good Manufacturing Practice (GMP). The amendment aims to enhance the rationality and efficiency of the medical device conformity assessment system by introducing a basis for expedited review of life-supporting devices, removing duplicate evaluations in contract manufacturing, and clarifying the scope of on-site inspections. Key Details of the Amendment Establishment of Expedited Review Procedures A framework will allow expedited review of medical devices essential for life support, surgery, or emergency care, as well as newly developed or innovative devices. This is intended to minimize commercialization delays and improve patient access when rapid market supply is needed due to manufacturing or import suspension. Streamlining Review Procedures Between Contracting Parties If a manufacturer already holds a valid conformi...