COMPANIES

&

PRODUCTSMedicaldeviceindustryinJapanCHAPTER

01OverviewRevenueofthemedicaldevicesmarketinJapanfrom2018to2028(inbillionJapaneseyen)RevenueofthemedicaldevicesindustryinJapan2018-20286,0005,0004,0003,0002,0001,0000201820192020202120222023202420252026202720283Description:Therevenueinthe'MedicalDevices'segmentofthemedicaltechnologymarketinJapanwasforecasttocontinuouslyincreasebetween2024and2028byintotal1.1trillionJPY(JP￥)(+26.03percent).Afterthesixthconsecutiveincreasingyear,theindicatorisestimatedtoreach5.3trillionJPY(JP￥)andthereforeanewpeakin2028.ReadmoreNote(s):Japan;2018to2028Source(s):HealthMarketInsightsRevenueofthemedicaldevicesmarketinJapanfrom2018to2028,bysegment(inbillionJapaneseyen)MedicaldevicerevenueinJapan2018-2028,bysegmentOtherMedicalDevicesOrthopedicDevicesCardiologyDevicesOphthalmicDevicesDiagnosticImagingDevicesGeneral&PlasticSurgeryDevices5,0004,5004,0003,5003,0002,5002,0001,5001,0005000201820192020202120222023202420252026202720284Description:Overthelasttwoobservations,therevenueisforecasttosignificantlyincreaseinallsegments.Aspartofthepositivetrend,theindicatorreachesthemaximumvalueforallsixdifferentsegmentsattheendofthecomparisonperiod.ParticularlynoteworthyisthesegmentOtherMedicalDevices,whichhasthehighestvalueof1.5trillionJPY(JP￥).ReadmoreNote(s):Japan;2018to2028Source(s):HealthMarketInsightsProductionvalueofmedicaldevicesinJapanfrom2013to2022(intrillionJapaneseyen)ProductionvalueofmedicaldevicesJapan2013-20223.02.52.62.582.492.41.991.991.951.951.911.912.01.51.00.50.020132014201520162017201820192020202120225Description:In2022,theproductionvalueofmedicaldevicesinJapanstoodatapproximately2.58trillionJapaneseyen.Thefigureincreasedcomparedtoaround1.91trillionyenin2013.Theaverageproductionvalueofmedicaldevicespermonthin2022amountedtoabout215billionyen.ReadmoreNote(s):Japan;2013to2022Source(s):MHLW(Japan)ShareofproductionvalueofmedicaldevicesinJapanin2022,bycategoryShareofmedicaldeviceproductionvalueJapan2022,bycategoryShareofproductionvalue0%2%4%6%8%10%12%14%MedicalmirrorCannulae/cathetersofassortedtipconfigurationsArtificialinternalorgans11.9%9.4%9.2%9.2%Medicalx-rayequipment/TubeformedicalX-rayequipmentTestinginstrumentsforbloodTestinginstrumentsforinternalorgansPhysicaltherapyinstrumentsandequipmentOrthopedicarticle7.5%5.3%4.8%4.5%Dentalmetal4%SightcorrectiveophthalmiclensesMedicalinjector3.3%3.2%X-rayfilmTestinginstrumentsforeye2.2%2.1%6Description:In2022,medicalmirrorsaccountedforthelargestshareofabout12percentofthetotalmedicaldeviceproductioninJapan.Cannulaeorcathetersofassortedtipconfigurationsfollowedwith9.4percent.

ReadmoreNote(s):Japan;2022;leading20categoriesSource(s):MHLW(Japan)NumberofmedicaldevicemanufacturersinJapanin2022,byproductionvalueNumberofmedicaldevicemanufacturersJapan2022,byproductionvalue6004785004003002001000395343184146914736Under1millionJPY

1tolessthan5millionJPY5tolessthan10

10tolessthan50

50tolessthan100

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500milliontoless

1billionJPYandmillionJPY

millionJPY

millionJPY

500millionJPY

than1billionJPY

overMonthlyproductionvalueonaverage7Description:In2022,therewere478medicaldevicemanufacturersinJapanwithamonthlyproductionvalueofbelowonemillionJapaneseyen.Inthesameyear,47manufacturersreportedamonthlymedicaldeviceproductionvalueofonebillionyenandoveronaverage.ReadmoreNote(s):Japan;2022;manufacturesthathadmanufacturedgoodsduringtheperiodSource(s):MHLW(Japan)AveragecapitalinvestmentofgeneralhospitalsinJapaninfiscalyear2022,bypurpose(inmillionJapaneseyen)AveragecapitalinvestmentpergeneralhospitalJapanFY2022,bypurposeAveragecapitalinvestmentinmillionJapaneseyenperfacility20

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1200140160180200220TotalMedicaldevices195.7680.59Buildings(includingaccompanyingfacilities)Dispensingequipment65.7522.1Hospitalindormationsystem(HIS)equipment1.318Description:Asurveyconductedin2022foundthattheaveragetotalcapitalinvestmentofgeneralhospitalsinJapanamountedtoapproximately195millionJapaneseyen.Anaverageofaround80millionyenwasspentonmedicaldevices.

ReadmoreNote(s):Japan;fiscalyear2022;theJapanesefiscalyearstartsonApril1ofthestatedyearandendsonMarch31ofthefollowingyear;679medicalfacilities;basedonsurveyresults;hospitalswhoserevenuesfromnursingcareaccountedforlessthantwopercentofthetotalrevenueSource(s):MHLW(Japan)CHAPTER

02SalesSalesvalueofmedicaldevicesandpharmaceuticalgoodsofmedicaldevicemanufacturersandsellersinJapaninfiscalyear2022,byproducttype(inbillionJapaneseyen)SalesofmedicaldeviceandpharmaceuticalgoodsJapanFY2022,bytypeSalesvalueinbillionJapaneseyen05001,0001,5002,0002,5003,0003,500TherapeuticequipmentanddevicesDiagnosticequipmentsanddevicesOphthalmicgoodsandrelatedproductsDentalmaterialandrelateddevicesMedicaldevicesforhomeuse2,885.281,977.56397.25166.36118.18Medicalandhygienicproducts79.5Clinicalequipmentandsupplies62.1410Description:Inthefiscalyear2022,thevalueoftherapeuticequipmentanddevicesalesofmedicaldevicemanufacturersandsellersinJapanamountedtoaround2.9trillionJapaneseyen.Diagnosticequipmentaccountedforthesecond-highestsalesvalue,atabouttwotrillionyen.ReadmoreNote(s):Japan;fiscalyear2022;theJapanesefiscalyearstartsonApril1ofthestatedyearandendsonMarch31ofthefollowingyear;includingdomesticandoverseassalesSource(s):MHLW(Japan);StatisticsBureauofJapanDomesticsalesvalueofnationallyproducedmedicaldevicesandpharmaceuticalgoodsofmedicaldevicemanufacturersandsellersinJapaninfiscalyear2022,byproducttype(inbillionJapaneseyen)DomesticsalesofnationalmedicaldeviceandpharmagoodsJapanFY2022,bytypeSalesvalueinbillionJapaneseyen01002003004005006007008009001,000TherapeuticequipmentanddevicesDiagnosticequipmentanddevicesOphthalmicgoodsandrelatedproductsDentalmaterialandrelateddevicesMedicalandhygienicproducts874.11476.93122.2488.852.77Medicaldevicesforhomeuse47.61Clinicalequipmentandsupplies37.311Description:Inthefiscalyear2022,thedomesticsalesvalueofJapanesetherapeuticequipmentanddevicesamountedtoapproximately874billionJapaneseyen.Thatyear,thetotaldomesticsalesofnationallyproducedpharmaceuticalgoodsandmedicaldevicesofmedicaldevicemanufacturersandsellersinJapanreachedabout1.7trillionyen.ReadmoreNote(s):Japan;fiscalyear2022;theJapanesefiscalyearstartsonApril1ofthestatedyearandendsonMarch31ofthefollowingyear;domesticsalesvalueSource(s):MHLW(Japan);StatisticsBureauofJapanOverseassalesvalueofmedicaldevicesandpharmaceuticalgoodsofmedicaldevicemanufacturersandsellersinJapaninfiscalyear2022,byproducttype(inbillionJapaneseyen)OverseassalesofmedicaldeviceandpharmaceuticalgoodsJapanFY2022,bytypeSalesvalueinbillionJapaneseyen02004006008001,0001,2001,110.57DiagnosticequipmentanddevicesTherapeuticequipmentanddevicesOphthalmicgoodsandrelatedproductsDentalmaterialandrelateddevicesMedicaldevicesforhomeuse1,007.5996.0816.4315.97Medicalandhygienicproducts

3.25Clinicalequipmentandsupplies

3.0912Description:Inthefiscalyear2022,theoverseassalesofdiagnosticequipmentanddevicesofmedicaldevicemanufacturersandsellersinJapanamountedtoapproximately1.1trillionJapaneseyen.Theoverseassalesoftherapeuticequipmentanddevicesaccountedforthesecond-largestshareofthetotaloverseassalesvalue,witharoundonetrillionyen.ReadmoreNote(s):Japan;fiscalyear2022;theJapanesefiscalyearstartsonApril1ofthestatedyearandendsonMarch31ofthefollowingyearSource(s):MHLW(Japan);StatisticsBureauofJapanWholesalevalueofmedicaldevicesinJapaninfiscalyear2022,bycustomertype(inbillionJapaneseyen)WholesalevalueofmedicaldevicesJapanFY2022,bycustomertypeSalesvalueinbillionJapaneseyen600

80002004001,0001,2001,400HospitalsWholesalerOther1,280.9409.13189.79Clinics138.16LeasingbusinessRetailer25.3312.713Description:Inthefiscalyear2022,hospitalswerethelargestcustomersregardingthewholesaleofmedicaldevicesinJapan,accountingforasalesvalueofapproximately1.3trillionJapaneseyen.Thatyear,thetotalwholesalevalueofmedicaldevicesatmedicaldevicewholesalecompaniesinJapanamountedtoaround2.74trillionyen.ReadmoreNote(s):Japan;fiscalyear2022;theJapanesefiscalyearstartsonApril1ofthestatedyearandendsonMarch31ofthefollowingyearSource(s):MHLW(Japan);StatisticsBureauofJapanCHAPTER

03TradeImportvalueofmedicaldevicestoJapanfrom2013to2022(intrillionJapaneseyen)ValueofmedicaldeviceimportstoJapan2013-20223.53.02.52.922.742.582.532.01.651.621.561.421.51.00.50.01.371.3201320142015201620172018201920202021202215Description:In2022,approximately2.9trillionJapaneseyenofmedicaldeviceswereimportedtoJapan.Thismarkedanincreasecomparedto2.74trillionyeninthepreviousyear.

ReadmoreNote(s):Japan;2013to2022Source(s):MHLW(Japan)DistributionofmedicaldeviceimportstoJapanin2022,bymaincategoryShareofmedicaldeviceimportsJapan2022,bycategoryShareofmedicaldeviceimports0%5%10%15%20%25%30%OrthopedicarticleCannulae/cathetersofassortedtipconfigurationsSightcorrectiveophthalmiclensesArtificialinternalorgans15.8%14.5%11.5%10.8%PhysicaltherapyinstrumentsandequipmentTestinginstrumentsforinternalorgansMedicalx-rayequipment/TubeformedicalX-rayequipmentMedicalmirror6.8%3.9%2.8%2.7%2.5%2.4%OrthopedicmachineryandequipmentRespiratingequipmentOther26.4%16/statistics/772443/japan-medical-devices-imports-distribution-by-categoryIn2022,orthopedicarticleaccountedforthelargestshareofthemedicaldeviceimportstoJapan,with15.8percent.Cannulae/cathetersofassortedtipconfigurationsfollowedwith14.5percentoftheimportvalueofmedicaldevicestothecountry.

ReadmoreNote(s):Japan;2022;basedontheimportvalueSource(s):MHLW(Japan)DistributionofmedicaldeviceimportstoJapanin2022,byregionShareofmedicaldeviceimportsJapan2022,byregionShareofmedicaldeviceimports0%5%10%15%20%25%30%35%40%UnitedStatesIreland35.7%10.1%China8.5%GermanyMexico6.8%4%ThailandPuertoRicoSwitzerlandMalaysiaSouthKoreaOther3.8%3.5%3.1%2.9%2.5%19.1%17Description:In2022,JapanimportedthelargestshareofmedicaldevicesfromtheUnitedStates,whichaccountedforover35percentofthetotalimportedproducts.Irelandrankedsecondwithashareofaround10percentofimports.Thatyear,thetotalvalueofmedicalequipmentimportstoJapanamountedtoapproximately2.9trillionJapaneseyen.ReadmoreNote(s):Japan;2022Source(s):MHLW(Japan)ExportvalueofmedicaldevicesfromJapanfrom2013to2022(inbillionJapaneseyen)ValueofmedicaldeviceexportsfromJapan2013-20221,2001,0001,094.141,004.21974.78953.54800667.63622.58618.99583.96572.336004002000530.5201320142015201620172018201920202021202218Description:In2022,theexportvalueofmedicaldevicesfromJapanreachedtooveronetrillionJapaneseyen,upfromabout530billionyenin2013.Theexportvaluein2022increasedbyaroundninepercentcomparedtothepreviousyear.

ReadmoreNote(s):Japan;2013to2022Source(s):MHLW(Japan)DistributionofexportsofmedicaldevicesfromJapanin2022,bymaincategoryShareofmedicaldeviceexportsfromJapan2022,bycategoryShareofmedicaldeviceexports5%0%10%15%20%25%MedicalmirrorTestinginstrumentsforblood21.9%13.5%Medicalx-rayequipment/tubeformedicalX-rayequipmentArtificialinternalorgans12%8.5%Cannulae/cathetersofassortedtipconfigurationsPhysicaltherapyinstrumentsandequipmentX-rayfilm5.7%5.6%4.6%3.9%3.5%TestinginstrumentsforinternalorgansTestinginstrumentsforeyeDentalAdhesiveandFillingMaterialsOther2.3%18.5%19Description:In2022,medicalmirrorsrankedfirstwith21.9percentshareamongmedicaldeviceexportsfromJapan.Testinginstrumentsforbloodfollowedwith13.5percentshare.

ReadmoreNote(s):Japan;2022Source(s):MHLW(Japan)DistributionofexportsofmedicaldevicesfromJapanin2022,byregionShareofmedicaldeviceexportsfromJapan2022,byregionShareofmedicaldeviceexports0%5%10%15%20%25%30%35%40%45%50%55%UnitedStatesChina15.8%10.4%GermanyNetherlandsBelgiumSouthKoreaHongkongIndia7.3%5.2%3.3%2.5%2.2%1.5%Russia1.4%1.3%BrazilOthers49.1%20Description:Witharound16percent,theUnitedStatesreceivedthelargestshareofJapanesemedicaldeviceexportsin2022.Thatyear,thetotalvalueofmedicaldeviceexportsfromJapanamountedtoroughlyonetrillionJapaneseyen.

ReadmoreNote(s):Japan;2022Source(s):MHLW(Japan)CHAPTER

04LeadingmanufacturersRevenueofOlympusCorporationfromfiscalyear2014to2023(inbillionJapaneseyen)OlympusCorporation'srevenueFY2014-20231,000900881.92804.58793.86786.5764.678007006005004003002001000755.23750.12740.56730.54713.29201420152016201720182019202020212022202322Description:Inthefiscalyear2023,therevenueofOlympusCorporationwascloseto882billionJapaneseyen,thehighestamountofthepastdecade.ReadmoreNote(s):Japan;fiscalyear2014to2023;company'sfiscalyearstartsonApril1ofthepreviousyearandendsonMarch31ofthestatedyearSource(s):OlympusRevenuedistributionofOlympusCorporationinfiscalyear2023,bysegmentOlympusCorporation'srevenueshareFY2023,bysegmentOther1.3%Therapeuticsolutions36.1%Endoscopicsolutions62.6%23Description:Inthefiscalyear2022,OlympusCorporationgeneratedabout34percentofitstotalrevenueinNorthAmericaand25percentinEurope.Establishedin1919,Olympuswastheleaderingastrointestinalendoscopicequipment,retainingthemajorityoftheglobalmarketshareasof2022.ReadmoreNote(s):Japan;fiscalyear2023;company'sfiscalyearstartsonApril1ofthepreviousyearandendsonMarch31ofthestatedyearSource(s):OlympusRevenueofTerumoCorporationinfiscalyear2013to2022(inbillionJapaneseyen)Terumo'srevenueFY2013-2022900800700600820.21703.3628.9613.84599.48587.78525.03514.16489.515004003002001000467.36201320142015201620172018201920202021202224Description:Inthefiscalyear2022,therevenueofTerumoCorporationamountedtoapproximately820billionJapaneseyen,representinganincreasefromthepreviousfiscalyear.Foundedin1921,TerumoisoneofthemajormedicaldevicemanufacturersheadquarteredinTokyoPrefecture,Japan.ReadmoreNote(s):Japan;fiscalyear2013to2022;company'sfiscalyearstartsonApril1ofthestatedyearandendsonMarch31ofthefollowingyear;consolidateddataSource(s):TerumoShareofrevenueofTerumoCorporationinfiscalyear2022,bybusinesssegmentTerumo'srevenueshareFY2022,bybusinesssegmentBloodandcelltechnologiescompany18%Medicalcaresolutionscompany23%Cardiacandvascularcompany59%25Description:Inthefiscalyear2022,thecardiacandvascularcompanygeneratedaround59percentoftheconsolidatedrevenueofTerumoCorporation.Terumo'scardiacandvascularsegmentmainlymanufacturesproductssuchasradialcompressiondevices,intrasacculardevices,hollowfiberoxygenators,andsurgicalgrafts.Foundedin1921,TerumoisoneofthemajormedicaldevicemanufacturersheadquarteredinTokyoPrefecture,Japan.

ReadmoreNote(s):Japan;fiscalyear2022;company'sfiscalyearstartsonApril1ofthestatedyearandendsonMarch31ofthefollowingyear;consolidateddataSource(s):TerumoNetsalesofNiproCorporationfromfiscalyear2014to2023(inbillionJapaneseyen)Nipro'snetsalesFY2014-2023600500545.2494.79455.56442.52426.4395.4400366.65359.7325.08300.753002001000201420152016201720182019202020212022202326Description:Inthefiscalyear2023,NiproCorporationinJapanrecordednetsalesofapproximately545billionJapaneseyen,upfromaround495billionyeninthepreviousyear.Themedicalproductsrelatedbusinessaccountedforthelargestshareofsalesofthecorporationinfiscal2023.ReadmoreNote(s):Japan;fiscalyear2014to2023;company'sfiscalyearstartsApril1ofthepreviousyearandendedMarch31ofthestatedyear;consolidateddataSource(s):NiproSalesshareofNiproCorporationinthefiscalyear2023,bybusinesssegmentNipro'ssalesshareFY2023,bybusinessPharmapackaging10%Pharmaceutical-related13%Medical-related77%27Description:Inthefiscalyear2023,themedicalproducts-relatedbusinessaccountedforthelargestshareofsalesofNiproCorporationinJapan,witharound77percent.Thatyear,Niprogeneratednetsalesofapproximately545billionJapaneseyen.

ReadmoreNote(s):Japan;fiscalyear2023;company'sfiscalyearstartsApril1ofthepreviousyearandendedMarch31ofthestatedyearSource(s):NiproCHAPTER

05ResearchanddevelopmentexpensesAverageresearchanddevelopmentexpensesandcapitalinvestmentofmedicaldevicemanufacturersinJapanfromfiscalyear2014to2023(inmillionJapaneseyen)AverageR&DandcapitalinvestmentofmedicaldevicemanufacturersFY2014-2023ResearchanddevelopmentexpensesCapitalinvestment3302,5002,0001,5001,0005006852,03955355440340439042934933577859558757051048645946833902014201520162017201820192020202120222023*29Description:Inthefiscalyear2023,itwasestimatedthatmedicaldevicemanufacturersinJapanspentanaverageofabout339millionJapaneseyenonresearchanddevelopment(R&D)and335millionyenoncapitalinvestment.TheaverageexpensesforR&Dpeakedinfiscal2020atovertwobillionyen.ReadmoreNote(s):Japan;fiscalyear2014to2023*;theJapanesefiscalyearstartsonApril1ofthestatedyearandendsonMarch31ofthefollowingyear;*Estimate.Figureswerebasedonasurvey.Thesurveywasconductedamong509certifiedmedical[...]

ReadmoreSource(s):MHLW(Japan);StatisticsBureauofJapanResearchanddevelopmentexpenditureofOlympusCorporationfromfiscalyear2014to2023(inbillionJapaneseyen)OlympusCorporation'sR&DexpenditureFY2014-202310093.9789.4787.75908070605040302010081.4281.7979.1876.8775.1974.166.8201420152016201720182019202020212022202330Description:Inthefinancialyear2023,theresearchanddevelopment(R&D)expenditureofOlympusCorporationamountedtoapproximately76.9billionJapaneseyen.ReadmoreNote(s):Japan;fiscalyear2014to2023;company'sfiscalyearstartsonApril1ofthepreviousyearandendsonMarch31ofthestatedyearSource(s):OlympusResearchanddevelopmentexpensesofTerumoCorporationinfiscalyear2013to2022(inbillionJapaneseyen)Terumo'sR&DexpenditureFY2013-202270605061.651.850.6249.147.6841.344033.1532.3830.1329.363020100201320142015201620172018201920202021202231Description:Theresearchanddevelopment(R&D)expensesofTerumoCorporationinthefiscalyear2022amountedtoapproximately61.6billionJapaneseyen,representinganincreasefromthepreviousfiscalyear.Foundedin1921,TerumoisoneofthemajormedicaldevicemanufacturersheadquarteredinTokyoPrefecture,Japan.ReadmoreNote(s):Japan;fiscalyear2013to2022;company'sfiscalyearstartsonApril1ofthestatedyearandendsonMarch31ofthefollowingyear;consolidateddataSource(s):TerumoResearchanddevelopmentexpensesofNiproCorporationfromfiscalyear2014to2023(inbillionJapaneseyen)Nipro'sR&DexpenditureFY2014-2023252019.6718.6518.7318.216.5316.111510511.5210.278.657.890201420152016201720182019202020212022202332Description:Inthefiscalyear2023,NiproCorporationspentabout19.7billionJapaneseyenontheresearchanddevelopment(R&D)expenses,anincreasefromthepreviousfiscalyear.Establishedin1954inOsakaPrefecture,Niprooperatesmainlyinthemanufacturingbusinessofmedicaldevicesandpharmaceuticalproducts.ReadmoreNote(s):Japan;fiscalyear2014to2023;company'sfiscalyearstartsApril1ofthepreviousyearandendedMarch31ofthestatedyear;consolidatedfiguresSource(s):NiproCHAPTER

06ApprovedproductsandpatentsNumberofmedicaldevicesnewlyapprovedbythePharmaceuticalsandMedicalDevicesAgency(PMDA)inJapanfromfiscalyear2014to2022,byapplicationtypeNumberofnewlyapprovedmedicaldevicesJapanFY2014-2022,byapplicationtypeNewPartialchange1,4001,2001,000800600400200065360654758956160536256660854260356753154450651446036420142015201620172018201920202021202234Description:Inthefiscalyear2022,overonethousandmedicaldeviceswerenewlyapprovedbythePharmaceuticalsandMedicalDevicesAgency(PMDA)inJapan,ofwhich364werefromnewapplications.ThePMDAfunctionsasaregulatoryagencyforpharmaceuticalproductsandmedicaldevicesandworkstogetherwiththeMinistryofHealth,LabourandWelfareinJapan.ReadmoreNote(s):Japan;fiscalyear2014to2022;theJapanesefiscalyearstartsonApril1ofthestatedyearandendsonMarch31ofthefollowingyearSource(s):PMDANumberofmedicaldevicesnewlyapprovedbythePharmaceuticalsandMedicalDevicesAgency(PMDA)inJapanfromfiscalyear2014to2022,bycategoryNumberofnewlyapprovedmedicaldevicesJapanFY2014-2022,bycategoryNewmedicaldevicesGenericmedicaldevicesImprovedmedicaldevices(withclinicaldata)Re-manufacturingsingle-usedevices(R-SUD)Improvedmedicaldevices(withoutclinicaldata)1,4001,2001,0008006004002000414686891776986882579976376460324053213352754921652231452204522544215422294767562627383222352120142015201620172018201920202021202235Description:Inthefiscalyear2022,over900medicaldeviceswerenewlyapprovedbythePharmaceuticalsandMedicalDevicesAgency(PMDA)inJapan,ofwhich603weregenericmedicaldevices.ThePMDAfunctionsasaregulatoryagencyforpharmaceuticalproductsandmedicaldevicesandworkswithJapan'shealthministry.ReadmoreNote(s):Japan;fiscalyear2014to2022;theJapanesefiscalyearstartsonApril1ofthestatedyearandendsonMarch31ofthefollowingyearSource(s):PMDANumberofnewmedicaldevicesapprovedbythePharmaceuticalsandMedicalDevicesAgency(PMDA)inJapanfromfiscalyear2013to2022,byyearofsubmissionNumberofapprovednewmedicaldevicesJapanFY2013-2022,byyearo