Medical Device Registration Timelines in Korea
Medical devices are divided into four classes. Registration timelines vary according to classification.
Class 1
- Class 1 devices do not require submission of KGMP certification or product testing data in the pathway illustrated below.
- Class 1 device notification typically takes 2–3 months.
- The timeline below allows for first and second requests for additional information.
Classes 2, 3 and 4
- Timelines depend on whether testing in Korea, a KGMP on-site audit or clinical data review is required.
- Class 2 device certification typically takes 6–9 months.
- Class 3 and 4 device approval typically takes 9–12 months, reflecting the longer MFDS review process.
- The timeline below assumes a Class 2 device, testing in Korea, a KGMP document review and no clinical data review.
