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Korea MFDS Introduces New Self-Testing IVD Categories for Influenza and Drugs of Abuse

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The Ministry of Food and Drug Safety (MFDS) amended the Regulation on IVD Medical Device Items and Item Classification ( Notification No. 2026-45 ) on June 30, 2026, establishing two new categories of self-testing in vitro diagnostic medical devices (IVDs) for influenza and drugs of abuse. The amendment expands public access to self-testing IVDs by broadening the scope beyond the existing nine self-testing IVD categories, including those for pregnancy, blood glucose, and COVID-19. The newly introduced influenza self-test kit is expected to enable rapid identification of infected individuals during the early stages of infection, helping to reduce disease transmission. In addition, the drugs of abuse self-test kit will allow individuals to quickly determine whether they have been unintentionally exposed to illicit drugs, supporting timely and appropriate responses.   The newly established self-testing IVD categories are as follows. • K05070.01 IVD reagents for self testing of I...
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Korea Updates KC EMC Applicability for Home Network Terminals

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The Korea National Radio Research Agency (RRA) has amended the Notification on Conformity Assessment of Broadcasting and Communication Equipment ( Notification No. 2026-2 ), effective June 26, 2026, to clarify the applicability of the KC EMC Conformity Assessment to Home Network Terminals. The amendment adds Home Network Terminals, such as wall-mounted smart home control panels, to the list of representative products under Information Technology Terminal Equipment, a subcategory of Multimedia Equipment covered by Korea's KC EMC Conformity Assessment. Information Technology Terminal Equipment refers to equipment that performs independent information processing functions and is used either independently or by connecting to a computer via a network or wired connection. Previously, representative products included display control terminals, POS terminals, barcode scanners, electronic calculating terminals, copiers (including multifunction printers), and multi-card readers. By adding H...
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Korea Energy Efficiency Rating and Labeling Requirements for Dehumidifiers

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Manufacturers and importers planning to place dehumidifiers on the Korean market should determine whether their products are subject to Korea's Energy Efficiency Rating. Dehumidifiers subject to Korea's Energy Efficiency Rating Program are electric dehumidifiers designed to reduce indoor humidity. Specifically, the scope covers products that operate on single-phase AC 220V power, incorporate a refrigeration compressor and fan within a single cabinet, and have a rated power consumption of 1,000W or less. Products are assigned energy efficiency grades from Grade 1 to Grade 5 based on their energy efficiency, while products that fail to meet Korea's Minimum Energy Performance Standards (MEPS) are prohibited from being manufactured or sold. Before being placed on the Korean market, applicable products must complete the required energy efficiency testing and registration procedures and display the Energy Efficiency Rating Label. The Energy Efficiency Rating Label for dehumidifie...
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Audio Equipment KC Certification: Frequently Overlooked e-Standby Requirements in Korea

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Recently, cases have been identified where audio equipment placed on the Korean market complies with KC Product Safety and EMC/RF requirements, but the mandatory registration under the e-Standby Program has been overlooked. Products subject to the e-Standby Program must complete the required registration before being introduced to the Korean market. Manufacturers and importers are therefore advised to review the applicable regulatory requirements in advance to avoid unnecessary business risks and potential market compliance issues. •  What is the e-Standby Program? The e-Standby Program is one of Korea's mandatory energy efficiency programs, designed to promote the reduction of standby power consumption in electronic products. Manufacturers and importers of regulated products must test their products in accordance with the prescribed technical standards and measurement methods and complete the required registration with the Korea Energy Agency within 60 days after completion. ...
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Korea Identifies Energy Efficiency Regulation Violations for Monitor Products

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During the 2026 post-market surveillance conducted by the Korea Energy Agency, numerous cases of non-compliance with energy consumption efficiency registration and labeling requirements were identified for monitor products. Accordingly, companies marketing monitor products in Korea should review their compliance with additional model registration requirements and energy consumption efficiency labeling regulations. What is an Additional Model? An additional model refers to a model to which the company has assigned a new model name due to changes such as feature enhancements, production period, color, or handle position, without any change in energy consumption efficiency. However, where energy consumption efficiency is affected by changes to the electrical or mechanical internal structure, the addition or removal of components, or the introduction of new functions, the product shall be registered as a separate new model rather than as an additional model. Key Violation Cases •  Sa...
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KC Certification Series (RRA) | SDoC (Supplier’s Declaration of Conformity)

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This post covers SDoC (Supplier's Declaration of Conformity), one of the approval types under the RRA Conformity Assessment Scheme. For an overview of the RRA Conformity Assessment Scheme and applicant definitions, please refer to the previous post. →   RRA Conformity Assessment Guide (RF, EMC, SAR) KC Certification - Korea RRA SDoC Overview SDoC (Supplier’s Declaration of Conformity) SDoC is one of the conformity assessment types under the Radio Research Agency (RRA) Conformity Assessment Scheme. It applies to broadcasting and communication equipment with a low risk of electromagnetic interference. Manufacturers, importers, and sellers must conduct testing in accordance with the conformity assessment standards, either by themselves or through a third-party testing laboratory, prepare a Self-Conformity Declaration, and disclose the relevant information on the RRA website . 1. Target Devices • USB/Battery-Powered Household Appliances, Electric Tools, Audio/Video Devices, Office ...
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Korea Updates Video Information Management Requirements for Autonomous Vehicles

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Korea's Ministry of Land, Infrastructure and Transport (MOLIT) promulgated the Amendment to the Act on the Promotion andSupport of Commercialization of Autonomous Vehicles on March 17, 2026, with the amendment taking effect on June 18, 2026. Reason for the Amendment 1.      To impose obligations regarding the technical and administrative measures necessary to ensure the security of video information collected by autonomous vehicles, as well as requirements for the destruction of such information, and to establish penalties or administrative fines for non-compliance. 2.      To prescribe matters delegated by the Act and necessary for its implementation, including the scope of video information processing devices, the establishment of internal management plans for video information, and the retention of access records. Frequently Asked Questions Q. When does this amendment take effect? The amendment takes effect on June 18, 2026, having been promulgat...
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