Korea KC Certification | GCA

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...

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...

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...

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...

1. Approval Type MEPS (Minimum Energy Performance Standards) : Applies to products such as Refrigerator, Air Conditioner, Washing Machine, Vacuum Cleaner, Air purifier, Fan, AC adapter, TV, Monitor, Dish washing machine, Computers (Desktops, Laptops), Electric rice cooker, Electric range(Induction), Electric fan heater, Clothing care appliance, Bidet, Portable air conditioner, Tubular LED lamp(external converter type), Pump, Multifunction printer, etc. - January 1st, 2026: Clothing care appliances (e.g., LG Styler) and Bidets. Note : Korean importers shall be the applicant for foreign manufacturers.   2. MEPS Labeling Requirements Refrigerators ✔ Grade 1 and 5 AC adapter/Chargers, Computers ✔ Product compliant with MEPS Monitors ✔ Power consumption in on-mode ✔ Product compliant with MEPS   3. Submission of the annual report to KEA Local manufacturers and importers shall submit a production/import and sales performance report annually ➡ GCA KORE...