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KC Mark and Electrical Safety

The KC (Korea Certification) mark is a mandatory safety certification for electrically-powered consumer products under the Electrical Appliances and Consumer Products Safety Control Act.

Does my medical device need a KC mark?​

Many electrically-powered medical devices require both:

  1. MFDS 품목허가 / 품목신고 — medical device regulatory approval
  2. KC mark certification — electrical product safety certification

These are separate certifications managed by different regulatory bodies: MFDS handles medical device approval/notification, while KESCO (Korea Electrical Safety Corporation) and other accredited Conformity Assessment Bodies (CABs) handle KC mark certification.

KC mark process​

  1. Test device against applicable KS/IEC standard at a KC-accredited laboratory
  2. Submit to a Conformity Assessment Body (CAB) for KC certification
  3. Affix the KC mark on the device and in the labelling before sale

Exemptions​

Some devices used exclusively in professional clinical settings may be exempt from KC mark requirements. However, exemptions are rare and must be verified with KESCO or a qualified Korean regulatory consultant on a case-by-case basis before proceeding without certification.

"Device classes and KC mark requirements

Generally, the following are more likely to require KC marks:

  • Powered surgical instruments and diagnostic equipment
  • Patient monitoring devices with electrical components
  • Powered mobility aids and therapeutic devices

Devices less likely to require KC marks include non-powered devices, in vitro diagnostic devices (IVDs) used only in clinical laboratories, and implants used exclusively in surgical settings. However, this determination must be made on a case-by-case basis and verified with KESCO."