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 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...

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...