Korea KC Certification | GCA

MFDS Simplifies Import Procedures for Personal-Use Medical Devices. The Ministry of Food and Drug Safety (MFDS) of Korea has officially announced a partial amendment to the Regulation on Exemption from Import Requirements for Medical Devices , simplifying the process for patients with rare and intractable diseases who regularly import personal-use medical devices with no domestic equivalent for diagnosis or treatment. ( Notification No. 2026-27 ) This amendment took effect on the date of its announcement, March 31, 2026. Key Changes Before: Patients were required to re-submit a medical certificate (or doctor's opinion) every time they reimported a medical device that had previously received an import requirement exemption. After: A medical certificate (or doctor's opinion) is required only for the initial submission. For subsequent reimports, the original documentation on file is accepted in lieu of a new submission. GCA Korea provides expert support for global compan...

The 2026 Guide to KC Safety Previous: Part 1: Safety Certification Guide Part 2: Safety Confirmation Guide Part 3: Supplier’s Declaration of Conformity Guide The label shall be affixed before product release for locally manufactured products, and before customs clearance for imported products.   KC Mark and certificate no. (safety certification and confirmation) Other information ‧ Product name and model name ‧ Manufacturer name or importer name/Manufacturing country ‧ Manufacturing date (year and month or Lot no.) ‧ After-sales service telephone no. (local service center tel. no.) ‧ Information required according to each safety standard (such as rating voltage, power frequency, current, warning statement)   If all information above, including KC mark and certificate no., is attached to the product, the information may be omitted on the package. The label should be put on the product or on the package by a printing or inscribing method. The label may ...

KC Safety Certification to Safety Confirmation: Korea has finalized the transition for certain electrical products. The Korean Agency for Technology and Standards (KATS) is reclassifying certain electrical products from safety certification to safety confirmation, reflecting the growing diversity of product types and the rapid pace of change driven by technological advancement and evolving market conditions. ( Notification No. 2026-56 ) The amendment takes effect on April 1, 2026, the date of its promulgation. Items removed from safety certification and changed to safety confirmation Electric cleaners Electric Washing machines and spin dryers Microwave ovens (operating in the frequency range of 300   MHz   –   30   GHz) Electric dryers Electric appliances for bathroom use Transitional measures for existing products Products that have already received 'safety certification' before the enforcement of this notification are recognized as having completed th...

Planning to introduce your Bluetooth wireless keyboard or mouse brand to the Korean market? Make your launch smooth and compliant by understanding the essential KC certification requirements for lawful distribution. KC Certification Requirements for a Bluetooth Wireless Keyboard or Mouse A Bluetooth Wireless Keyboard or Mouse • Power: Battery • Certification Type: KC Conformity Registration (EMC/RF) Note 1 : Including USB dongle. Note 2 : If the product uses a battery charging method, it contains a lithium-ion battery and therefore requires KC Safety Confirmation testing. Note 3 : If RF module installed in the product is approved, RF test is not needed. Check here   for the KC certification: Sample Quantity, 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 Autom...

  The Ministry of Food and Drug Safety (MFDS) has announced a proposed amendment to the Regulation on Exemption from Import Requirements for Medical Devices, which would exempt patients with rare or intractable diseases who regularly import medical devices for personal use, due to the lack of alternative products available in Korea, from repeatedly submitting medical certificates with every import. ( Announcement No. 2026-127 ) Public opinions on the proposed amendment will be accepted until March 29, 2026. Key Changes A medical certificate (or opinion letter) will only need to be submitted only once at the initial application when applying for an import requirement exemption for personal-use medical devices. For subsequent imports, the import requirement confirmation shall be substituted with the previously submitted medical certificate (or opinion letter). The MFDS is expected to reduce the economic and administrative burden associated with obtaining medical certificates (or opin...

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...

The KC safety standards for electrical appliances, KC 60335-2-29 (Household and similar electrical appliances - Safety - Part 2-29 ： Particular requirements for battery chargers), have been revised. Key changes include expanded ripple-free DC output voltage range and refined charger type classifications to align with updated international standards, under Notification No. 2026-23 . The new standards take effect immediately, effective on February 5, 2026. Note : Existing Safety standards remain in parallel until February 5, 2027. KC 60335-2-29     Previous   Revised Applicable Standards IEC 60335-2-29 Ed 5.0 (2016-06) IEC 60335-2-29 Ed 5.1 (2019-03) Ripple-free DC Output Range Up to 120 V Up to 250 V Charger Types Single Criterion Introduction of Type 1·Type 2   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 Efficien...