欧洲公共卫生组织支持加强医疗器械监管力度

幸福侠侣

欧洲公益组织The European Public Health Alliance (EPHA)改变其在医疗器械上的态度，通过与欧盟政府对话后转而支持欧盟政府准备加强对医疗器械的监管。EPHA认为对医疗器械制造商制造医疗器械的过程实行更加严格的监管有利于医疗市场的正常发展并有利于患者的利益。

　详细英文报道：

　　The European Public Health Alliance (EPHA), a network of nonprofits and NGOs, updated its position on medical devices one year after it released its original paper. Based on member discussions and EU developments, the organization says it now supports more stringent and aligned procedures, more transparency in the authorization process and stricter controls and requirements for manufacturers. It also recommends devicemakers' mandatory involvement in ethics committees, the inclusion of patients and health professionals in the governance structure, clearer information and instructions on devices and an expanded mandate for supervising bodies. Overall, the group wants tighter regulations for the med tech industry.