In order to receive MFDS ClassII certification, technical document review by technical document review agency is essential.
Currently, the fee for reviewing technical documents for second-class medical devices has been frozen for 13 years, resulting in a vicious cycle of worsening management of review institution, delayed complaint processing periods, and deterioration of civil service.
To reflect the issues caused by the fee freeze and the status of fee increases for other tasks, the technical document review fee will be increased from 2024.02.01.
| Category | Current fee | Increase fee | Note |
| New | 1,400,000 | 2,464,000 | Effective from 24.2.1 (10% VAT excluded) |
| Change | 1,100,000 | 1,936,000 | |
| Combination (New) | 1,700,000 | 2,992,000 |
Please note the increased fee(1stage) that will apply from February 2024.
Additionally, the fee is scheduled to increase step by step every year.
| Number | Name of the institution | Expiration date |
| 10-1 | Korea Testing Laboratory, KTL | 2025.12.31 |
| 10-3 | Korea Testing Certification institute, KTC | 2025.12.31 |
| 10-4 | KOREA CONFORMITY LABORATORIES, KCL | 2025.12.31 |
| 10-5 | Korea Testing & Research Institute, KTR | 2025.12.31 |
| 10-6 | SGS Korea Co., Ltd. | 2025.12.31 |
| 14-1 | National Institute of Medical Device Safety Information, NIDS | 2026.07.06 |
| 19-1 | KMEDIhub | 2025.01.07 |
| 20-1 | YONSEI UNIVERSITY HEALTH SYSTEM MFDS Accredited laboratory | 2026.05.31 |
Currently, there are a total of 8 MFDS technical document review organizations (Class II).
The scope and review items are different for each technical document review organizations, Please refer to it for work.
If you have any questions about medical device in Korea,
Please contact us with the below.
ra@jnmglobal.net