Device Classification in Korea.

Class 2

• Definition: Devices with low potential risk
• Examples: Syringes, patient monitors, powered wheelchairs, low-frequency stimulators and surgical gloves
• Technical documentation review bodies: MFDS-designated bodies (KTL, KTR, KCL, KTC, etc.)
• Technical documentation review period: 25 business days for initial review; 15 business days for changes
• Technical documentation review fee: KRW 2,400,000 for initial review; KRW 1,800,000 for changes

Class 3

• Definition: Devices with moderate potential risk
• Examples: Joint prostheses, CT scanners, dental implants, ventilators, peritoneal dialysis equipment and fluoroscopy systems
• Technical documentation review authority: Ministry of Food and Drug Safety (MFDS), Korea
• Technical documentation review period: 55 business days without clinical trial data; 70 business days with clinical trial data
• Technical documentation review fee: KRW 561,000 without clinical trial data; KRW 1,338,000 with clinical trial data 

Class 4

• Definition: Devices with high potential risk
• Examples: Breast implants, pacemakers, cardiopulmonary bypass systems, tissue repair biomaterials and vascular grafts
• Technical documentation review authority: Ministry of Food and Drug Safety (MFDS), Korea
• Technical documentation review period: 55 business days without clinical trial data; 70 business days with clinical trial data
• Technical documentation review fee: KRW 561,000 without clinical trial data; KRW 1,338,000 with clinical trial data   

Related Information

• Medical Device Registration Pathway in Korea
• Medical Device Registration Timelines in Korea