This paper describes the features and status of radiation sterilization of medical devices in the world. The key points include establishment of modern commercial radiation company; establishment of dosimetry system; dose setting and auditing; validation of process; routine control; intranet management and product identification system; establishment of quality system; and radiation protection and safety. It is emphasized that the following should be paid great attention to in the near future: seizing opportunities for development; following the international level in construction of quality system; and establishing modern enterprise system.