Abstract: Accidental sharps injuries are a serious problem in healthcare, many healthcare workers acquire infectious diseases from bloodborne pathogens by sharps injuries during their work. The cost of injury and exposure takes an emotional and financial toll, which has attracted worldwide attention. This paper analyzed the regulatory requirements on sharps injury prevention devices in the United States and the European Union, described the classification and basic requirements of sharps injury prevention devices, evaluation of protective functions, risk identification and control to provide references for regulation and development of such products in our country.