KGMP guideline revision
The Korean GMP (KGMP) guideline has been updated earlier this year (2016) and even if it was only provided in Korean we prepared a translated version in English.
More details were provided in the guideline and the case of in vitro diagnostic equipment was considered since those were reclassified as medical devices.
In addition to this, companies willing to register their product in Korea should also keep in mind that the process has changed recently.
As a consequence, the KGMP certificate must be obtained first (site audit) and then the manufacturers can apply for their product licenses.