GHTF Medical Device Regulati***
In1992,medicaldevicegovernmentcompetentdepartmentandindustryrepresentativesfromAmerica,EuropeanUnion,Japan,CanadaandAustraliaheldthefirstGHTFmeeting.Afterthatthemeetingwasheldannually.Themeetingisaimedatexchangingmedicaldevicesupervisionandmanagementsituationwithothercountriesanddiscussingrelatedregulationandtechnologystanda***soastoachievethebasicagreementofothercountriesandeliminateunnecessarybarriersinthemedicaldevicetradecenter.TherearefourteamsinGHTFregulationwhichisresp***iblefordiscussinganddraftingdocuments:Thefirstresearchteamisresp***ibleforcoordinateworksofmedicaldevicemanagementregulationsystem.Thesecondresearchteamisresp***ibleforcoordinateworksofsupervisionandwarningsystemafterenteringthemarket.Thethirdresearchteamisresp***ibleformedicaldevicequalitysystem.Thefourthresearchteamisresp***ibleforcoordinateworksofmedicaldevicequalitysystemverification.O***undamedicaldevicec***ultingorganization(Guangzhou,Beijing,Shanghai,Suzhou,ShenzhenandJinan),investinginChinafromCanada,isprofessionallyengagedinmedicaldeviceregulationc***ulting,medicaldeviceregisteredagent,medicaldevicemanagementsystemcertificationandproductcertification,focusingonprovidingmedicaldeviceenterprisesinternationalmedicaldeviceregistration(CE、FDA、CMDCAS、TGA、JPAL、SFDA、PPE)、medicaldevicesystemcertification(ISO13485、YY/T0287、GMP、QSR820、GSP),doingsecondandthirdpartyauditformedicaldevicesuppliers,providingdetailinformationofc***ultingthemedicalproductionmanufacturinglicense.)
Osmunda Medical Device Consulting CO.LTD
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