US: +1 512 898-9222
SG: +65 3138-4148
Sout Korea GMP Certification
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||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).
South Korea Regulatory Support
US: +1 512 898-9222
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