Particle radiotherapy using proton and heavy ion beams has shown improved clinical results and is a promising cancer therapy which is expected to gradually spread in Japan. There are, however, no special regulations for radiotherapy treatment facilities. They have been operated under the same safety regulations as for a research facility using a research accelerator. Significantly high-energy radiation is necessary for particle radiotherapy compared with conventional radiation therapy. The treatment facility, therefore, should have a large accelerator, which is installed in a room with a thick shield wall. Data on radiation protection for such high energy medical facilities is fragmentary and insufficient. In this study, we examined the necessity of other regulations for the safe operation of medical facilities for particle radiotherapy. First, we measured activation levels of the therapeutic devices and of patients. Next the safety level of the medical facility was evaluated from the viewpoint of radiation protection. We have confirmed the facilities can be safely operated by present regulations given in the Law Concerning Prevention from Radiation Hazards due to Radiation Isotopes, etc. or the Law for Health Protection and Medical Care.