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What is KGMP?

KGMP(Korea Good Manufacturing Practice) is almost identical to ISO13485 except that Korea health authorities look at the aspects required by the Korea regulations on medical device. As you may have experienced, Korea regulations on device registration and distribution are different than those of other countries, the auditors from the Korea health authorities consider these aspects as well. When a new manufacturer seeks a medical device registration, an on-site audit must be received. Otherwise, when a valid KGMP certificate to a manufacturer exists, KGMP certification may be completed through a paper audit.


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