Eachmedicaldevicemanufacturingenterprisemusth***eamedicaldevicemanufacturingenterpriselicense,whichissupervisedandissuedbylocalSFDA.Enterpriseswhowanttoobtainthelicensemustmeetnationalmedicaldeviceindustry’sdevelopmentplanandindustrialpolicy.TheSFDAshouldregulatethemedicaldeviceenterprises.Andtheconditi***forenterprisestoobtainthelicenseareasfollows:Ⅰ.Peoplewhoareresp***iblefortheproduction,qualityandtechnologymusth***etheprofessionalabilityofproducingmedicaldevicesandfullyunderstandthelawandregulationofmedicaldevicesupervisionandrelevantproducts’qualityandtechnology.Workerscannotbeinchargebothofqualityandproduction.Ⅱ.Theproportionoftechnicianswhoisprimaryorjuniororabovemustmeettherequirementofproduction.Ⅲ.Enterprisesmustprovideproductionfacilitiesthatmeettheproductsandscaleofproduction,place,storageandenvironment.Enterpriseswhoh***esomespecialrequirementforthefacilityandenvironmentofproductionmustmeettheindustrialandnationalstandard.Ⅳ.Enterprisesshouldsetupqualityinspectionbodyandh***ethequalityinspectingabilitythatmeetstheproductionvarietiesandscale.Ⅴ.Enterprisesmustkeeprelatedlaws,regulati***andstanda***aboutproducingandmanagingmedicaldevice.Ⅵ.IfenterpriseswanttodotheproductionofclassⅢmedicaldevice,Inadditiontopossessalltheconditi***above,thefollowingconditi***areneeded:1.Internalauditorswhoqualifiedforthequalitymanagementsystemmustnotlessthantwo.2.Fulltimetechnicalstaffwhoisjuniororcollegedegreeoraboveforrelatedmajormustnotlessthantwo.O***undaisaservicegroupwhichisengagedinmedicaldeviceregulationc***ulting,medicaldeviceregisteredagent,medicaldevicemanagementsystemcertificationandproductcertification,focusingonprovidingmedicaldeviceenterprisesinternationalmedicaldeviceregistration（CE、FDA、CMDCAS、TGA、JPAL、SFDA、PPE）、medicaldevicesystemcertification（ISO13485、YY/T0287、GMP、QSR820、GSP）,doingsecondandthirdpartyauditformedicaldevicesuppliers,providingdetailinformationofc***ultingthemedicalproductionmanufacturinglicense.)