澳洲注册申请表中涉及的问题

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1、问题是下面标批注的三个问题Device・HTAQuestionsChangestotheMedicalDeviceApplicationformforinclusionsBackgroundHealthTechnologyAssessmentforReimbursementTheTGAassessesapplicationsforentryoftherapeuticgoodsincludingmedicaldevicesandinvitrodiagnosticmedicaldevices(IVDs)

2、ontheAustralianRegisterofTherapeuticGoods(ARTG)toenablesupplyinAustralia.AsponsorormanufacturermayseekpublicorprivatefundingforatherapeuticgoodunderanAustralianGovernmentfundingprogrameitheroncethegoodisapprovedforsupplyoratsometimeinthefuture.Fundingp

3、rogramsthatusehealthtechnologyassessment(HTA)toinformwhetheratherapeuticgoodshouldbelistedforfundinginclude:PhairnaceuticalBenefitsScheme(PBS)forpharmaceuticalsNationalImmunisationProgram(NIP)forvaccinesMedicareBenefitsSchedule(MBS)forhealthtechnologie

4、srequiringamedicalprocedureProsthesesListforprivatehealthinsurancefundingofprosthesesNationalBloodAgreementforbloodandbloodproductsUndertheHTAprocess,healthtechnologiesareassessedinregardtotheircomparativeclinicaleffectivenessandcosteffectiveness.Thisa

5、imstoensurethattaxpayers5moneyisusedtosupportthehealthcareinterventionsthatachievethemaximumhealthimprovementatthelowestcost.Eachoftheaboveprogramshasawebsitethatprovidesinformationaboutthefundingprogram,eligibilitycriteria,makingapplicationandassessme

6、ntprocesses-EntryontheARTGisoneoftheeligibilitycriteriathatmustbemetbeforeatherapeuticgoodcanbelistedforfunding.Applicantsseekingfundingunderanyoftheseprogramsareencouragedtoreviewtherelevantwebsiteand/orcontacttheappropriatesecretariatpriortomakingana

7、pplication.Co-dependentorhybridtechnologiesSometherapeuticgoodscanbeco-dependent(forexample,adrug/diagnostictestcombination)orhybridtechnologies(forexample,amedicaldevicewithanintegrateddrug)andmaythereforeneedtobeconsideredforeligibilityundertwoormore

8、ofthesefundingprograms.Co-dependenttechnologiesaretherapeuticgoodsthataredependentonanothertechnology,eithertoachievetheirintendedeffectortoenhancetheirintendedeffect(forexample,in-situhybridisation(ISH)testingrelatedtoeligibilityfortra