In September 2017, the therapeutic rTMS device for major depression was approved in Japan and will be covered by the national public health insurance. The Japanese Society of Psychiatry and Neurology (JSPN) formulated an appropriate use document for rTMS, as commissioned by the Japanese Ministry of Health, Labour and Welfare (MHLW). In this chapter, the content of the JSPN document (a guide to the appropriate use of rTMS 2018) is explained, referring to the discussion at the JSPN working group. The ethical principles in medical practice are known as beneficence, non-maleficence, autonomy, and justice. According to these four principles, the medical ethics of rTMS are briefly summarized. The target population of rTMS was defined in the JSPN document as adults older than 18 years of age with moderate to severe depressive episodes resistant to sufficient doses of an existing antidepressant. In the treatment algorithm for major depression, rTMS is located at the second line or later, and the range of rTMS application is limited compared with that of antidepressants. In terms of the efficacy of rTMS for major depression, the effect size is moderate, the response rate is 30 to 40%, and the remission rate is 20 to 30%. One frequent side effect is scalp pain during stimulation, with an incidence rate of approximately 30%. Measures against scalp pain are required, especially for patients with a higher motor threshold. The most serious side effect is rTMS-induced seizure, with an incidence rate of less than 0.1% per patient. In order to minimize its risk, some countermeasures should be considered in advance. Absolute contraindications are any metal or implanted medical devices that are close to the stimulation site or a cardiac pacemaker. rTMS cannot be used for patients with absolute contraindications. For patients with relative contraindications, rTMS may be performed at a general hospital if the benefits outweigh the risks and patients provide informed consent. Specific examples of off-label use of rTMS are listed in the JSPN document in order to avoid the spread of off-label use. Careful attention on how the clinical introduction of rTMS will change the clinical field of major depression in Japan and how the JSPN document will contribute to the appropriate use of rTMS is needed.
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