亚太地区在进行临床活动成果.pdf

•Newregulation-ClassIIandIIIproductsthat

meetoneofthecriteriawouldrequirelocal

CT(ClinicalTrial)beforeregistration:

–NotunderCTexemptlist,andnoPredicate

–UnderCTexemptlist,butnopredicate

–UnderCTexemptlist,haspredicate,butnorelevant

clinicalliture

•1StCTExperience-LutonixDrugCoated

Balloon

•OtherpotentialCTlistludevariousprojects

underdifferentdivisions(exampleslude):

–BAS–PICCS

–BPV–LifeStream(proposingreducedCTscale);Crosser

•Impactonregistrationtiming,productlaunch

andoverallbudgetnning

•Clinicalactivities-notforregistrationpurposebut

forenhancinglocalclinicianrelationshipanduser

experience,promotepublication

•InvestigatorinitiatedstudiesandBardsponsorsit.

–BASPowerPortandLTX

•Currentregulationstipulatescertainmedicaldevices

wouldrequirelocalCTforregistration:

–Rigidgaspermeablecontactlenses,softcontact

lensesandotherdevicesTBDbyTFDA

Korea

•Sponsor(Bard)initiatedtrial-LUTONIXDrugCoatedBalloon

Catheter-Prospective,Multicenter,SingleArm,Post-Market

Registry

•Investigatorinitiatedstudies–foracademicperformanceand

obtainingclinicalevidence:

–ArcticSunandGelPad

–Twostudies,oneforcardiacarrestandtheotherformildhypothermia

•Koreaisseenasamatureclinicalstudyenvironment,

complianttoISO14155

Korea

•Clinicalreportsarerequiredfor“new”deviceor“designated”device

•Newdevicemeansthatdevicehasnewmaterials,newindicationsornew

technology.Ifacomingproductisclassifiedasnewdevice,theclinical

reportsarerequired.

•Designateddeviceswerelistedbutthosearenotofficiallyannouncedyet.

–VascularStent,Iliac