医疗器械出口苏丹要的文件~~~~~急 急 急~大虾，请帮忙~~~~

1. copy of standard export certificate of the device to sudan issued by the mdra of the country of origin . 2. standards complied with in the design and manufacture of the device to satisfy an effectivenessand safety requirements . 3. a summary of the studies on which the manufacture relies to ensure that the device meets safety and effectiveness requirements 4.. in case of a near patient in vitro diagnostic device provide a summary of investigational testing conducted on human subjects under similar conditions of use 5. bibliography of published reports dealing with use safety & effectiveness of the device) attach). 6. certificate to foreign government issued by the mdra of the country of origin (yes/ no). 7. european conformity issued by an accredited in eu countries (yes/ no). 8. free sale certificate from one of the global harmonization task force (yes/ no). 9. adoption of the legality authorized shows full responsibility for the product. 请大虾为小女子解读上面要求，mdra是什么机构？万分感谢。