Medical device labeling requirements in Korea are outlined by the Minister of Food and Drug Safety (MFDS) in Articles 20-23 of the Medical Device Act. All labeling must be in Korean language.
Medical Device Labeling Requirements
Container or outer package of a medical device must be labeled with the following descriptions:
In addition to the labeling on the outer packaging, medical devices must include a package insert in either electronic or printed form with the following information:
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