*The summary of the permit system for each level is as follows.
In addition to registration of product, you have to get certificate of GMP system called as other countries like EU, US, etc.
The contents of KGMP is substantially same to those of ISO 13485. Therefore, if you have GMP system in accordance with ISO 13485, you don’t need setup of new system or total revision. You can get certificate of KGMP with just a little modification and/or supplementation on existing system.
The audit may include on-site audit. If it is first registration to KFDA, you have to prepare for the audit.
We supplies consulting service related to KGMP certification as well as product registration.