The definition and diagnostic criteria of dry eye disease (DED) proposed by the Japan Dry Eye Society and other countries are reviewed. The first definition and criteria of DED in Japan were proposed in 1995. In that report, DED was considered a disease of tears, which subsequently damaged ocular epithelia. The presence of subjective symptoms was not included in the criteria. In 2006, a new definition proposed that interactions between the tear film and ocular surface epithelia play important roles in DED. The presence of subjective symptoms, including visual disturbances, changes in tears, and epithelial damage were proposed to be major components of DED, and eyes positive for all three components were diagnosed as "definitive dry eye." A third version was proposed in 2016, which emphasized unstable tear films as a core finding in DED. Following this guideline, eyes with an abnormally low tear film breakup time and the presence of subjective symptoms are considered to have DED. The current definition and criteria are different from those proposed in other countries. For example, the recently published DED definition by the Dry Eye WorkShop II (DEWS II) of the Tear Film and Ocular Surface Society (TFOS) focuses more on the underlying pathogenesis of DED, including inflammation, hyperosmolarity of tears, and neurosensory abnormalities, as well as unstable tear films.