South Korea Medical Device Labeling

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:

• Name and address of the manufacturer/importer
• If imported, the name of the manufacturer, the country of origin
• Approval (certification or report) number
• Product name (including title of product group and model name)
• Lot number
• Date of manufacture/expiry date
• Weight or packing unit
• Mark indicating the product is a medical device
• Indication for single-use products
• Medical device Standard Code

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:

• Instructions for Use and precautions
• Instructions for maintenance and inspection, when necessary
• Information designated by the MFDS

Contact Asia Actual to see if our Korea labeling solutions are right for your needs.