Medical Device Classification in Korea
According to the "Criteria and Procedures for the Classification and Designation of Medical Devices" in Appendix 1 of the Medical Device Act Enforcement Rules of South Korea, medical devices are classified into four categories as follows. The review period for regulatory approval (technical document review) differs depending on the classification.
Class 1
- Definition: Medical devices with minimal potential for harm
- Examples: Manual wheelchairs, examination lamps, vision charts, medical gloves, etc.
- Review Authority: National Institute of Medical Device Safety Information (NIDS)
- Review Period: 5 business days
- Review Fee: 85,000 KRW
Class 2
- Definition: Medical devices with low potential for harm
- Examples: Syringes, patient monitoring devices, electric wheelchairs, low-frequency stimulators, surgical gloves, etc.
- Review Authority: FDA-designated review institutions (e.g., KTL, KTR, KCL, KTC)
- Review Period: 25 business days for initial review, 15 business days for modified review
- Review Fee: 2,400,000 KRW for initial review, 1,800,000 KRW for modified review
Class 3
- Definition: Medical devices with moderate potential for harm
- Examples: Artificial joints, CT scans, dental implants, ventilators, peritoneal dialysis devices, X-ray diagnostic devices, etc.
- Review Authority: Korea Food and Drug Administration (MFDS)
- Review Period: 55 business days without clinical trials, 70 business days with clinical trials
- Review Fee: 561,000 KRW without clinical trials, 1,338,000 KRW with clinical trials
Class 4
- Definition: Medical devices with high potential for harm
- Examples: Breast implants, pacemakers, heart-lung machines, tissue repair biomaterials, artificial blood vessels, etc.
- Review Authority: Korea Food and Drug Administration (MFDS)
- Review Period: 55 business days without clinical trials, 70 business days with clinical trials
- Review Fee: 561,000 KRW without clinical trials, 1,338,000 KRW with clinical trials