In April of 2012, the KFDA (now MFDS) enacted a new requirement for foreign manufacturers of Class II, III, and IV medical devices to obtain Korea Good Manufacturing Practice (KGMP) certification.
In order to apply for a KGMP Certificate, a local importer must submit the application on behalf of the foreign medical device manufacturer. After receiving the application materials, the MFDS will then determine whether to conduct an on-site inspection or conduct only a document review. Currently, the MFDS plans to perform approximately 20 to 30 on-site inspections per year and will approve most other KGMP Certification applications through a document review only.
Once issued the product license is valid for up to 3 years.
| Situation |
Activity |
Government Fees |
| 1st KGMP certification / KGMP certificate renewal |
3-day on-site audit |
US$4,324 (₩5,040,217) |
| 4-day on-site audit |
US$5,146 (₩5,998,692) |
| 5-day on-site audit |
US$5,968 (₩6,957,167) |
| Documentation audit |
1st KGMP audit |
US$1,528 (₩1,781,402) |
| KGMP certificate update |
US$1,069 (₩1,246,170) |
| Adding a KGMP category |
US$1,069 (₩1,246,170) |
| KGMP renewal with an on-site audit |
US$987 (₩1,150,170) |
| KGMP renewal without an on-site audit |
US$1,528 (₩1,781,402) |
Asia Actual can help prepare the South Korea GMP certification application and proctor the on-site audit (if required).
Identifying Predicate Devices in India, Taiwan, China, Japan, and KoreaOctober 25, 2022 - 12:28 pm
