FromFebruary11th2002,allcompaniesandmanufacturerswhoapplyfortheFDAregistrationoutsideAmericah***etoinformtheFDAtheirAmericanauthorizedrepresentative’sname,addressandphonenumber.EverycompanymustassignauniqueAmericanauthorizedrepresentativenomatterhowmanyproductsofmedicaldevice,medicineorbiologicalproductitproducts.It’smainpurposeistomakeitconvenientforFDAtocontactortodealwithsomeregulationfairswithAmericanagent.Besides,theAmericanagentcandealwithannualregistrationandpayment,additionalproductregistration.Also,hewillhelpFDAwiththeimportregulationproblemsandrelevantauditing.AmericanmedicaldeviceagentmustbeAmericanorenterpriseagentinAmerica,notaansweringmachineorafaxmachineorjustanemailaddress.AsanAmericanagent,itmustbecontactedin24hours.IftheAmericanagentcannotbecontactbyFDAafterregistration,thatenterprisewillbecancelthisregistrationandmustberequiredtoregisteragain.Andthismayle***eabadimpressiononFDAbecauseofsomefakeinformationtheenterpriseprovided.Themainresp***ibilityoftheAmericanagentistohelpFDAtocontactwithrelevantforeignenterprises,toanswerquesti***aboutimportedproductsandschedulingforforeignfactory’sexamination.IfinformationordocumentscannotbesenttoforeignenterprisesimmediatelybyFDA,theycanreceivedbyrelatedAmericanmedicaldeviceagent.Someenterprisesmayfeelveryconfusedintheprocessofdigitalregistrationbecauseoftheirlimitedunderstandingofforeignlanguage,professionalabilitiesandFDAregistrationregulati***.Therefore,tofindanAmericanagentisafastandconvenientwayforenterprisesandtheirexportedproducts.O***undamedicaldevicec***ultingorganizationistheonlyc***ultingorganizationwhichfocusesonthefieldofmedicaldevice.Weareabletoprovidemedicaldevicesregulati***c***ulting,medicaldevicesregistrationc***ulting,medicaldevicesgoodmanufacturingpractice(GMP)c***ulting,ISO13485registrationc***ulting,FDA510Kregistration,FDAmedicaldevicesagentservice,EuropeanCEregistrationc***ultingandmedicaldevicesclinicaltrailandotherservices.)