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Do you know how many medical device categories are in Korea?

In Korea medical devices are classified under over 2,000 categories set by MFDS (Ministry of Food and Drug Safety). These 2,000 categories are grouped into 26 KGMP categories, and a KGMP certificate to “KLH/manufacturer/KGMP category of the product (these three must be paired)” must be obtained during the device registration process.



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