Commonly Asked Questions
Is ISO 13485 compliance required in Korea?
Although ISO 13485 is the basis for Korean GMP, an ISO 13485 certificate issued by a European Notified Body or Canadian Registrar will not be accepted as proof of compliance with Korean GMP. You will need to modify your procedures to meet the specific requirements of KGMP.
How long is my KGMP certificate valid?
KGMP certificates must be renewed every three years. The recertification process should be started at least 90 days prior to expiration.