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Korea MFDS Proposes Regulations on Standards and Methods for Performance Evaluation of IVDs

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As the performance evaluation system for In Vitro Diagnostic Medical Devices (IVDs) has come into effect, the Ministry of Food and Drug Safety (MFDS) plans to establish the “ Regulations on Standards and Methods for Performance Evaluation of In Vitro Diagnostic Medical Devices ” ( Announcement No. 2026-236 ) in order to provide detailed criteria beyond those specified in the relevant regulations. Public comments on the proposed regulations will be accepted until June 4, 2026. Korea MFDS in vitro diagnostic medical devices Definitions Defines the terms used in this regulation for the performance evaluation of In Vitro Diagnostic Medical Devices (IVDs). Standards and Methods Provides for the application of standards and specifications under Article 19 of the Medical Devices Act, Korean Industrial Standards (KS), international standards such as ISO and IEC, and test specifications established at the time of approval or certification of In Vitro Diagnostic Medical Devices (IVDs) as standar...
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KC Certification Series (RRA) | Registration of Conformity

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Before diving into the details, you may want to review our previous post, “ KC Certification | RRA Conformity Assessment Guide (RF, EMC, SAR) ”, to better understand the overall framework and applicant definitions. KC Certification RRA Conformity Registration Korea overview Registration of Conformity Conformity Registration is one of the approval types under the Radio Research Agency (RRA) Conformity Assessment Scheme. It applies to broadcasting and communication equipment that presents a relatively lower risk of radio interference and electromagnetic hazards than equipment subject to Conformity Certification. It is a mandatory certification scheme requiring registration through testing conducted by designated test laboratories.   1. Target Devices ISM products using high frequency , audio/video products (TV, Amplifier, CCTV camera), household appliances (vacuum cleaner, washing machine, electric oven, mixer, air purifier), ITE products (computers and internal components...
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KC Certification Series (RRA) | Certification of Conformity

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Before diving into the details, you may want to review our previous post, “ KC Certification | RRA Conformity Assessment Guide (RF, EMC, SAR) ”, to better understand the overall framework and applicant definitions. KC Certification RRA Conformity Certification Korea overview Certification of Conformity Conformity Certification is one of the approval types under the Radio Research Agency (RRA) Conformity Assessment Scheme, and it is a mandatory certification applied to devices with a high risk of radio interference or those closely related to human safety. 1. Target Devices Mostly wireless devices (wireless microphone, mobile phone (LTE, WCDMA), base station, repeater, Wi-Fi & Bluetooth products (certification or registration), RFID (900MHz), Implantable wireless device, Keyfob, 5G NR (3.5GHz & 28GHz) etc.) and wired equipment (digital CATV set-top box etc.) ※ Important Notes for Wi-Fi & Bluetooth Products Wi-Fi and Bluetooth products may be subject to either certific...
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Air Purifier MEPS in Korea: KC Energy Efficiency Scope and Labeling Rules

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To launch air purifiers in the Korean market, it is essential to understand and comply with KC Energy Efficiency and MEPS (Minimum Energy Performance Standard) requirements. We provide guidance on key regulatory information, including the scope of application and labeling requirements, to support a successful market entry. Air Purifier Energy Efficiency Label 1. Scope of Application Air purifiers are subject to energy efficiency management if they meet the following conditions: • Mechanical and hybrid air purifiers within the scope of KS C 9314 • Rated input voltage of single-phase AC 220 V, rated frequency of 60 Hz, and a standard usable area of 200 m² or less • Includes products powered using an AC-DC conversion adapter However, the following products are excluded: • Products that are powered by or charged using a battery installed inside the main unit • Products that remove dust, odors, or gases using methods such as water spraying, without using filter media 2. Required Information...
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KC Certification | RRA Conformity Assessment Guide (RF, EMC, SAR)

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Under the KC certification and the RRA conformity assessment scheme, most electronic products marketed in Korea are subject to EMC testing, and RF or SAR testing may be required depending on their wireless functions. This is a mandatory certification system operated by the Radio Research Agency (RRA), and it is categorized into four types: • Certification of Conformity • Registration of Conformity • Supplier ’ s Declaration of Conformity (SDoC) • Interim of Conformity Korea  RRA Conformity Assessment Scheme Korean Law System • Radio Waves Act • Enforcement Decree of Radio Waves Act • Enforcement Rule of Radio Waves Act • Conformity Assessment Notification for Broadcasting and Communications Equipment   Definitions and Applicant Types •  Manufacturer A person who designs and directly manufactures the equipment or receives the equipment from OEM, and who is responsible for the design and manufacturing of the equipment •  Country of Manufacture...
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KC Certification Requirements for Portable Bluetooth Speakers in Korea

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Expanding your portable Bluetooth speaker brand to Korea? Ensure a seamless market entry by mastering the mandatory KC certification process for legal distribution. KC Certification - Portable Bluetooth Speaker KC Certification Requirements for Portable Bluetooth Speakers • Power: Battery • Certification Type: KC Conformity Registration (EMC/RF) • Sample Quantity: 1 normal (EMC), 1 conduction (RF) Note 1 : KC-approved battery shall be used. If not, they shall be approved. Note 2 : If RF module installed in the product is approved, RF test is not needed. Note 3 : USB Type-C receptacle connectors are required starting November 6, 2026. Check here for the KC certification: Timeline and required documents. GCA Korea provides expert support for global companies navigating Korea’s regulatory requirements, including KC Certification. Our expertise covers  KC EMC ,  KC Safety ,  KC Energy Efficiency ,  KC Automotive Components ,  KCsEx (ATEX, IECEx) ,  and  M...
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KC Safety Standards: Korea Is Changing the Rules for Inline Skates and Motorcycle Helmets. Are You Ready?

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KATS is set to revise regulations linked to KC safety standards for roller skates, inline skates, and protective helmets for vehicular users. The Korean Agency for Technology and Standards (KATS) plans to revise the Standards for Handling Nonconformity with Consumer Product Safety Standards and the Electrical Appliances and Consumer Products Safety Control Guideline to align with the updated safety standards for roller skates, inline skates, and protective helmets for vehicular users. (Announcement Nos. 2026-116 , 117 , and 118 ) Public opinions on this revision will be collected until April 30, 2026. Key Revisions Subdivision of inspection items for roller skates and inline skates: Inspection items will be updated to the latest standards, with performance-related categories subdivided. Associated defect classifications will be revised accordingly. Simplified model classification for roller skates and inline skates: The current classification system based on size and inten...
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