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.

Asia Actual can help prepare the South Korea GMP certification application and proctor the on-site audit (if required).