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

최종 수정일: 8월 19일

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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