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.
1st KGMP certification / KGMP certificate renewal
3-day on-site audit
4-day on-site audit
5-day on-site audit
1st KGMP audit
KGMP certificate update
Adding a KGMP category
KGMP renewal with an on-site audit
KGMP renewal without an on-site audit
Asia Actual can help prepare the South Korea GMP certification application and proctor the on-site audit (if required).