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KGMP is the quality system standard applied to the Korean domestic medical device manufacturer and, despite its name, is more closely modeled after ISO 13485:2003 and not US FDA requirements. Foreign manufacturers are now subject to Korea KGMP Certification requirements. In general, Class I devices are exempted from KGMP requirement (with the exception of 66 product categories).
KGMP Certifications are product category-specific and valid for three years. Also, the KFDA may opt to perform onsite inspections for novel devices, devices with a history of SAEs in the last 3 years, or when the documentation provided to the Ministry of Food and Drug Safety (MFDS, fomerly the Korea Food and Drug Administration, or KFDA) is deemed insufficient.
Emergo Group can assist to identify and bridge gaps in your ISO 13485 certified quality management system as well as compile, translate and submit your Korea Good Manufacturing Practice (KGMP) Certification application. Should an on-site audit be required by the MFDS, we offer translation, proctoring and preparatory services.