title: [Perspectives on the supervision of medical device software].
abstract: Medical device software is a special kind of medical device, which is different from hardware and may introduce more risk. How to reduce the risk of software efficiently is the important thing for medical device regulation system. This article analyzes medical device software's properties, introduces the status of foreign supervision, and finally gives some advises to the related parties.
authors.affiliation: The Center for Medical Device Standardization Administration, SFDA. xiaoyuan1976@vip.sina.com
authors.forename: Jun
authors.initials: J
authors.lastname: Li
authors.forename: Guozhong
authors.initials: G
authors.lastname: Yang
mesh_terms: D004864:Equipment and Supplies / Q000592:standards; D009934:Organization and Administration; D012984:Software