ABSTRACT
For most medical devices, the label on the product is the primary interface between the user and the product. As an integral part of the product proper, it provides a visual way to verify that the product in the packaging is what the user intends to use and ensures the packaging is used as intended. Labeling and languages are often mentioned in one breath. However, languages required by the respective countries or economies are just a subsection of the need to adapt the language of the instruction for use to the intended user or users. One of the key elements of labeling in the near future will be the use of a UDI, a unique device identifier. In Korea, a medical device label is one attached onto the outer most packaging though there does not appear to be an official reference to the definition of labeling.
