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Are Your Medical Device Products Affected? MFDS Korea Adds 4 New Device Types and a Class Change

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The Ministry of Food and Drug Safety (MFDS) has revised the  Regulation on Medical Device Groups and Class by Group  to improve the efficiency of medical device safety management. The revision addresses issues identified during the review and approval processes for medical device licensing, evaluation, and civil service handling. ( Notification No. 2026-18 ) The amendment took effect on March 9, 2026. Key Revisions 1. New Medical Device Subcategories Myopia control lens Vertebral body replacement implant Fixative system for laminoplasty and laminectomy Sustained Release Drug Delivery 2. Medical Device Class Adjustment impression, pre-treatment material, gingival retraction cord: Class II → Class I Note : Medical devices are classified into four classes, from Class I (lowest risk) to Class IV (highest risk), based on their intended use and potential impact on the human body. GCA Korea provides expert support for global companies navigating Korea’s re...

Direct vs Cloud: New RRA Segmentation of IP Camera Conformity Test Methods (Effective June 2026)

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To prevent confusion in applying the conformity assessment tests following the  revision of the Technical Standards for Terminal Devices  (December 22, 2025), a partial revision of the  IP Camera Terminal Device Conformity Assessment Test Method (KS X 3078)  will be implemented ahead of the full standard amendment.   This revision will take effect on June 23, 2026, and will remain in force until the national standard is formally revised. Key Amendments Segmentation of Test Methods: Testing is categorized into 'Direct Connection' and 'Cloud Connection' based on the terminal equipment access method. Strengthening Password Security: Mandatory change of factory-default passwords and stricter conditions for password Setting. Unauthorized Access Prevention: Implementation of login attempt limits and mandatory lockout periods after consecutive failed attempts. Cloud Security Verification: Verification of security protocols during cloud access using packet analysis...

Korea Introduces “Connected DTG” Under Revised Digital Tachograph Regulations

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To enhance the management of safe driving for vehicles required to be equipped with digital tachographs, such as commercial vehicles and school buses, the Enforcement Rule of the  Traffic Safety Act  has been amended to include records on the “status of digital tachographs and their communication condition” in the driving data submitted to traffic authorities. ( MOLIT Ordinance No. 1411 ) This amendment addresses identified shortcomings in the current system and took effect upon its promulgation on March 5, 2026. Key Amendments Establishment of methods for device and communication status codes Establishment of digits and display methods for fuel consumption and fuel efficiency Introduction of "Connected DTG" as a new category of Digital Tachograph Provision of driving record analysis results to transport operators through the driving analysis record and management system GCA Korea provides expert support for global companies navigating Korea’s regulatory requirements, includi...

Selling Coffee Makers in Korea? Don’t Let KC Certification Stall Your Launch!

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Expanding your coffee maker brand to Korea? Ensure a seamless market entry by mastering the mandatory KC certification process for legal distribution. Coffee makers are classified into two categories based on whether they have RF functionality, and both require mandatory KC safety certification.   KC Certification Requirements for coffee makers Coffee Maker (without RF) Power: AC Power Certification Type: KC Conformity Registration (EMC) Sample Quantity: 1 unit   Coffee Maker (with WiFi, Bluetooth) Power: AC Power Certification Type: KC Conformity Registration (EMC/RF) Sample Quantity: 1 normal (EMC), 1 conduction (RF) Note : If RF module installed in the product is approved, RF test is not needed.   Coffee Maker Power: AC Power Certification Type: KC Safety Certification Sample Quantity: 1 unit Note : Products more than 30 Vac or 42 Vdc are related to KC safety. / CB test report and certificate are accepted. / This product requires fac...

Reducing Lead Times for KC Safety SDoC: A Practical Guide

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The 2026 Guide to KC Safety Previous: Part 1: Safety Certification Guide Part 2: Safety Confirmation Guide Under the KC safety framework, electrical products are classified into three categories—Safety Certification, Safety Confirmation, or Supplier’s Declaration of Conformity (SDoC)—based on their associated risk levels. This part focuses on the SDoC scheme, which applies to products with relatively low risk. Note 1: Under KC safety regulations, the term " Manufacturer " refers strictly to the actual factory, a definition that differs from the one used by the RRA (Radio Research Agency). Note 2:  IEC CB test reports and certificates are accepted . Approval Types: Supplier’s Declaration of Conformity (SDoC) Product Categories: Household Appliances: DC air purifiers and DC ion generators (below 42 V DC) DC electric tools (charging type) Audio and video equipment: Video cameras, CCTV cameras, amplifiers, speakers with amplifiers ITE/office equipment: Scanners, walkie-talkies (i...

No Factory Inspection for TVs, dishwashers, Air Purifiers: Korean Market Entry

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The 2026 Guide to KC Safety Previous: Part 1: Safety Certification Guide In KC scheme, products such as electrical equipment are subject to Safety Certification, Safety Confirmation, or Supplier’s Declaration of Conformity, depending on their risk level. This guide focuses on the mid-risk Safety Confirmation scheme and outlines what you need to prepare. Note 1: Under KC safety regulations, the term " Manufacturer " refers strictly to the actual factory, a definition that differs from the one used by the RRA (Radio Research Agency). Note 2:  IEC CB test reports and certificates are accepted . Approval Types: Safety Confirmation Product Categories: Temperature controllers, timers (time switches), and electric welders. Household Appliances: Electric shavers, electric hair clippers, compressors, dishwashers, air purifiers, water purifiers, electric vehicle chargers (rated output power less than  200 kVA ), DC mixers, vending machines, and soldering irons. Audio and Video Equipmen...

Entering the Korean Market? Don't Miss These KC Safety Certification Essentials.

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This guideline applies to electrical equipment with a voltage rating exceeding 30 Vac or 42 Vdc . Please note that certain devices, such as notebooks and mobile phones, are subject to different standards. Note 1: Under KC safety regulations, the term " Manufacturer " refers strictly to the actual factory, a definition that differs from the one used by the RRA (Radio Research Agency). Note 2: IEC CB test reports and certificates are accepted . Approval Types: Safety Certification Product Categories: Cables, power cords, switches, power capacitors, power filters, plugs, sockets, inlets/outlets, fuses, and insulating transformers. Household Appliances: Vacuum cleaners, irons, electric ovens, washing machines, AC mixers, coffee makers, refrigerators, microwave ovens, air conditioners, and fans. Power & Battery Supplies: AC adapters (chargers) and Lithium secondary battery cells (specifically for smartphones, notebooks, or tablets with an energy density exceeding...