ELECTRO MEDICALS MARKET IN TURKEY
Contents
2
Healthcare Industry Overview - 3
Healthcare System - 5
Medical Devices Market - 8
Demand for Electro Medical Products in Turkey - 10
Major Sources of Demand - 12
Supply of Electro Medicals - 14
Major Suppliers and Position of Italy - 17
Opportunities in The Market - 21
Distribution Channels and Procurement - 22
Regulatory Framework - 24
Customs Duties - 26
Major Stakeholders in The Industry - 27
Healthcare Industry Overview
3
Increasingincomes,changingdemographicsandwidespreadaccesstohealthcareservicesaretheenginesofgrowthintheTurkishhealthcaresystem.Thehealthcareindustryhasbeenexpandingandisexpectedtocon<nueitsexpansionduetothebelowindicators:
Increasing Population
Ageing Population
Higher incidence of chronic diseases
Wider health insurance coverage
Increasing economic welfare
Changing Disease Profile
The growing popula<on and ageing demographicscontribute to the need to upgrade healthcareinfrastructureandincreasespending.
Investment Support and Promotion Agency of Turkey 23
The growing population and ageing demographics contribute to the need to upgrade healthcare infrastructure and increase spending
Figure 22: Population Dynamics in Turkey
Source: TurkStat, Deloitte Analysis
f: forecast, Note: There may exist differences due to rounding.
6% 7% 8% 8% 10% 21%
28%
60% 63% 66% 68% 69%
63% 58%
34% 30% 26% 25% 21% 16% 15%
0%
20%
40%
60%
80%
100%
1990 2000 2010 2013f 2023f 2050f 2075f
0-14
15-64
65+
70,6 75,6 84,2
93,5
0
20
40
60
80
100
2007 2012 2023* 2050*Source: TurkStat, Deloitte Analysis
* Forecast, Note: There may exist differences due to rounding.
Figure 21: Population of Turkey, (million people)
• The Turkish population is expected to grow at a
CAGR of 4.3% between 2012 and 2050 to an
estimated 93.5 million in 2050.
• Even though Turkey will continue to have one of
the youngest populations in Europe, its median age
will reach 34 in 2023, 42.9 in 2050 and 47.4 in
2075. Therefore, more than half of the population
will be over 47 years of age by 2075.
• The percentage of the population over the age of
65 is also on a rise as it will reach 10% of the total
population in 2023 and 28% in 2075.
• There is a positive correlation between age and the
possibility of suffering from chronic disease
requiring lifelong care which would also incur higher
medical costs. An ageing population coupled with
continued population growth would result in
increases in Turkey’s healthcare spending.
Investment Tip: An ageing population would result in an increased need for
skilled nursing facilities and certain other public buildings, such as schools. These would be designed with a view toward conversion into healthcare facilities in
the future.
CAGR
5.8%
Source: Turkish Statistical Institute, Deloitte Analysis
AgeGroups
Healthcare Industry Overview
4
The Turkish economy rapidly expanded in the last decadewith per capitaGDP* expanding at a CAGR ofmorethan20%between2002and2015.Inlinewithincreasedeconomicwelfare,healthcarespendingpercapitagrewataCAGR*of30%inthesameperioduptoalevelofUSD800.
Investment Support and Promotion Agency of Turkey
186 235 307 374 436 545
620 567 668 701 707 734 751 796 847 912
0
2
4
6
8
10
12
14
0
150
300
450
600
750
900
1050
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013f 2014f 2015f 2016f 2017f
US
D T
hou
sand
Healthcare Spending per Capita GDP per Capita
25
As economic welfare increased, Turkey’s healthcare spending grew at a CAGR of 30.6% between 2002-2012
• There is a strong correlation between economic welfare and the level of healthcare spending. As economic welfare increases, so do expectations for readily accessible and higher quality healthcare.
• The Turkish economy rapidly expanded in the last decade with per capita GDP expanding at a CAGR of 25.1% between 2002 and 2012 from USD 3,439 in 2002 to USD 10,550 in 2012. In line with increased economic welfare, healthcare spending per capita grew at a CAGR of 30.6% between 2002-2012 from USD 186 to USD 707.
Figure 25: Healthcare Spending per Capita and GDP per Capita in Turkey
• The Turkish economy is expected to continue its rapid expansion with GDP per capita reaching USD 13,303 in 2017. GDP per capita is projected to grow at a CAGR of 4.3% between 2012-2017, registering an increase of around USD 2,500.
• Healthcare spending will grow in line with improvements in economic welfare as it increases at a CAGR of 5.2% from USD 707 in 2012 to USD 912 in 2017. There is especially strong growth between 2015-2017, giving an indication that growth in healthcare spending per capita will continue to increase in the long term as well.
F: forecast Source: Economic Intelligence Unit
US
D
TotalhealthcareexpendituresinTurkeyiscurrentlymorethanUSD60Billion,whichaccountsfor7%oftheGDP.Around75%oftheexpendituresaregeneratedinPublicSector.
*CAGR: Compound Annual Growth Rate *GDP: Gross Domestic Product
Healthcare System
5
Turkeyhasa2-levelapproachtothedeliveryofpublichealthcareservices.First-leveltreatmentisdeliveredbyfamilyprac<<onerswhoareappointedtopopula<ongroupsof3,000peoplelivinginthesamearea.Forillnessesrequiringfurthertreatment,pa<entsarereferredbyfamilyprac<<onerstosecond-leveltreatmentfacili<es,whichare‘state’and‘university’hospitals.
TheMinistryofHealth(MoH)buildsandoperatesthe‘statehospitals’whichcons<tute59%ofthecurrenthospitalstockand62%ofcurrenthospitalbedcapacityinTurkey.
Ministry of Health,
874
University, 69
Private, 550
Ministry of Health, 123,703
University, 36,616
Private, 39,782
NumberofHospitals-2014 NumberofBeds-2014
Source: Ministry of Health (MoH)
Healthcare System
6
ThemajorityofprivatehospitalsarelocatedinwesternTurkey,withIstanbul(30%),Ankara(6%),Antalya(5%) and Izmir (4%) leading theway. The concentra<onofprivatehospitals ispropor<onal topopula<ondensity;Istanbul,Turkey’slargestcity,hasthehighestnumberofprivatehospitalsatmorethan150.
Inaddi<on,currently37%ofallhospitalsinTurkeyareprivate,asopposedto59%opera<ngundertheMoH(Ministry ofHealth)mandate. This also indicates the fairly highmarket penetra<onof private healthcareins<tu<onsinTurkey.
Investment Support and Promotion Agency of Turkey 34
Private hospitals in Turkey are concentrated in the western region, with the highest concentration in Istanbul
• The majority of private hospitals are located in western Turkey, with Istanbul (30%), Ankara (6%), Antalya (5%) and Izmir (4%) leading the way. The concentration of private hospitals is proportional to population density; Istanbul, Turkey’s largest city, has the highest number of private hospitals at 152.
• Other cities with high populations also have a high number of private hospitals. Ankara, the second largest city in Turkey after Istanbul, has 29 private hospitals, whereas Antalya and Izmir house 26 and 20 private hospitals respectively.
• Yet, the market penetration for private healthcare institutions is significant all over Turkey. There is at least 1 private hospital in every province, with 17 provinces having more than 10 private hospitals.
• In addition, as of 2012, 37% of all hospitals in Turkey are private, as opposed to 56% operating under the MoH mandate. This, yet again, demonstrates the fairly high market penetration of private healthcare institutions in Turkey.
Figure 33: Regional Distribution of Private Hospitals in Turkey, 2012
Source: TurkStat
37%
56%
4% 3%
Private
MoH
University
Other
Figure 34: Percentage of Private Hospitals in Turkey, 2012
Source: MoH
Source: Turkish Statistical Institute
NumberofHospitals
Healthcare System
7
Thelargestcapacityaddi<onsweretointensivecareunit(ICU)andqualifiedbeds.ThenumberofintensivecarebedsincreasedbytheremarkableCAGRof55%inthelast13years,demonstra<ngthatinvestmentsininfrastructurewerenotonlyfocusedonincreasingquan<ty,butweresignificantlyaimedat increasingthequalityofthehealthcareinfrastructure.
3,426 16,020 23,689 28,235
164,471 183,200
200,072 200,101
2002 2009 2012 2014
ICU Beds Total Beds
There is an emerging groupof hospitals thatwill be built andmanagedby the Public-Private-Partnership(PPP)model.TheMoH,whichhadbeenthesolebuilderofstatehospitals,hasrecentlybeencontrac<ngouttheconstruc<onandmanagementof29healthcarecampusesaroundTurkey.Eachcampuswillhouse2,000to4,000bedsdividedamonggeneralandspecializedhospitals,laboratories,andaccompanyingrecrea<onalareas.Whenconstruc<onofallthesecampusesisfinished,45,000bedswillhavebeenrenovated.
Source: Ministry of Health ICU: Intensive Care Unit
Medical Devices Market
8
Turkish medical devices market has been growinggraduallyandisrankedasthelargestintheregionoftheMiddle East and Africa. According to BMI Espicom, theTurkishmedicaldevicemarketcurrentlyreachedtoUSD3billion.Moreover, it is forecasted to grow at aCAGR of8.5% through 2018, buoyed by strong imports. Theexpansion of healthcare facili<es and rising healthexpenditure will be the main drivers of projected fast-pacedgrowth.
2,438 2,675 2,933 3,172
3,412 3,669
2013 2014 2015 2016 2017 2018
Medical Devices Market (USD Million)
Source: BMI Espicom Research Company
Investment Support and Promotion Agency of Turkey 55
The Turkish medical device sector is expected to expand at a CAGR of 8.5% over 2013-2018
0
5
10
15
20
25
30
35
40
45
50
0
500
1.000
1.500
2.000
2.500
3.000
3.500
4.000
2008 2009 2010 2011 2012 2013f 2014f 2015f 2016f 2017f 2018f
%
USD
Milli
on
Consumables Diagnostic Imaging Dental Products
Orthopaedics & Prosthetics Patinet Aids Other
USD Per Capita
2008-2012
CAGR: 2.1%
2013-2018
CAGR: 8.5%
Other items include: Wheelchairs, ophthalmic instruments, anesthesia equipment, dialysis equipment, blood pressure monitors,
endoscopy monitors and hospital furniture.
Source: BMI Espicom
• Turkey medical device market has been growing gradually and is ranked as the largest in the region of the
Middle East and Africa. According to BMI Espicom, the Turkish medical device market reached over USD 2.2
billion in 2012. Moreover, it is forecasted to grow at a CAGR of 8.5% through 2018, buoyed by strong imports.
The expansion of healthcare facilities and rising health expenditure will be the main drivers of projected fast-
paced growth.
Figure 50: Medical Device Market in Turkey, 2008-2018
Medical Devices Market
9
Consumable products have the highest share of 22% inoverallmedicaldevicesmarketwithUSD650millionmarketsize, which is followed by diagnos<c imaging devices withUSD550millionmarketsizeand20%share.
Chart below shows the forecasts for the medical devicesmarket in different product categorieswith a yearly growthof8,5%un<l2018.In2018,marketsizeofdiagnos<cimagingdevices is forecasted to increase up to USD 750 million.Along with the other related products, the overall electromedicalsmarketwillreachtoasizeofUSD1.5billion.
Consumables, 22%
Diagnostic Imaging,
20% Dental Products,
8%
Orthopedics and
Prosthetics, 15%
Patient Aids, 9%
Others, 26%
Source: BMI Espicom Research Company
Demand for Electro Medical Products in Turkey
10
AsTurkey’smedicaldeviceindustrygrows,sodoestheneedforhightechnologymedicaldevicesinparallelwiththeplannedexpansioninhealthcareinfrastructure.ThenumberofMRIandCTdevicesper1millionpopula<onis10.4and14.1,respec<vely.AlthoughTurkeyisabovemanyoftheupperincomecountries,its<lllagsbehindtheOECDaverage.Consideringtheprojectedgrowthpoten<al,itisexpectedthatTurkeywillfollowglobaltrendsandincreasethenumberofitsMRIandCTdevicestosa<sfyincreasingneed.
46.9
34.5
23.5
23.5
19.1
22.9
21.8
21.6
20.8
15.4
14.8
13.9
11.8
11.3
10.6
10.4
8.8
8.7
6.8
3 2.8
2.2
101.
3
50.5
33.3
37.1
50.5
34.8
40.5
21.8
34.6
29.3
17.1
23.7
10.9
18.6
14.3
14.1
14.6
13.5
8.7
9.2
7.7
5.1
0
20
40
60
80
100
120
MRI CT
Source: BMI Espicom Research Company
Demand for Electro Medical Products in Turkey
11
Sta<s<cofotherelectromedicaldevicesalsoindicateahugepoten<alinTurkishmarketcomparedtotheotherdevelopedcountries.Electromedicaldevicecountsofcountriespermillionpeopleareasfollows:Ø PETDevices:Denmark:6,1–USA:5-SouthKorea:4,1–Japan:3,65–OECDAverage:1,56–Turkey:0,94-Chili:0,46–
Hungary:0,4-Mexico:0,26Ø Radia[onTreatmentEquipment:Switzerland:16,7–Denmark:13,4–USA:12,5–Iceland:12,5–OECDAverage:5,5
–Turkey:2,4–Chili:1,9–Mexico:1,5–Israel:0,37Ø Mammography Devices: Greece: 57,8 – South Korea: 55,7 – USA: 40,2 – OECD Average: 17,4 – Turkey: 12,5 –
Luxemburg:9,2–Mexico:9–UK:8,6–Netherland:3,9Ø GammaCameraDevices:USA:47,2–Canada:20,6–Australia:19,9–OECDAverage:8,7–Estonia:2,3-Turkey:2,1–
Chili:1,5–Mexico:0,5
Source: Ministry of Health
562 625 678 709 750 798759 838 904 974 1,037 1,080
1,005
2,117 2,283 2,4363,775 4,282 4,756
681
1,0951,251 1,397
2,0912,480
2,793
259
689791
881
1,181
1,379
1,542
2002 2008 2009 2010 2011 2012 2013
MRI CT Ultrasound DopplerUltrasound Echo
Major Sources of Demand
12
Asmen<oned in the previous sec<ons, public ins<tu<ons governed byMinistry ofHealth dominate theTurkish healthcare market with the shares of 59% of the current hospital stock and 62% of currenthospitalbedcapacity.However,everincreasingpenetra<onofprivateins<tu<onsinthemarkethasalsoreachedtoremarkablelevels.
7,351 8,239 9,581 10,321 10,953 11,874
3,486 3,7263,890 4,236 4,917 5,129
2,204
5,1836,344
7,5069,132
10,09411,232
2002 2009 2010 2011 2012 2013 2014
MinistryofHealth University PrivateICUBedCounts
Althoughthepublicins<tu<onshavetheleadintotalnumberofbedswith%62share,correla<onofthisindicatorwiththeelectromedicaldeviceuseisweak.ComparingtheICUbedcountsismoremeaningfultoassesstheelectromedicaldeviceuseinpublicandprivateins<tu<ons.Abovechartpresentsaclearerviewtothemarketpenetra<onofprivateins<tu<ons,wheretheyhavea40%shareintermsofICUBedswhilepublicins[tu[onshave42%.
Source: Ministry of Health
Major Sources of Demand
13
University hospitals are ter<ary, yet an important source for the electromedical device demandwith astable growthof facili<es and ICU/qualifiedbeds. The currentdistribu<onof selecteddevices in Turkishhealthcaresystemwillgiveabekerinsightaboutthemarketstructure.
251 436
2,648
1,459
711323
95116
502
332
221
76452
528
1,606
1,002
610
506
MRI CT Ultrasound DopplerUltrasound Echo Mammography
MoH University Private
Source: Ministry of Health
Supply of Electro Medicals: Local Production
14
Theproduc+onofmedicaldevicesislimitedinTurkeyandthemajorityoftheincreasingdemandismetbyimports. Local produc<on is expected to increase in line with themoderniza<on of healthcare system,integra<on of EU standards and the expansion of healthcare service providers. Development of localproduc<onisalsobeingsupportedbythegovernment’stargetstospurmedicaldeviceexports.
Source: Ministry of Health *PPP: Public Private Partnership
The new PPP* legisla.on adopted in 2013 requires that at least 20% of the medicalequipmentusedinPPPbuilthealthcarefacili.estobesourcedbylocalmanufacture.
The local produc[on is strong especially inconsumableproductsanddentalproductsinmedicaldevices category, which have low value-add.However, there is significantly limitedknowhowandtechnology development in electromedical devices.Therefore, the overall share of local produc<on inmedicaldevicesis15%.
85%
15%
Imports Local Production
Supply of Electro Medicals: Imports
15
OverallmedicaldeviceimportsinTurkeyreachedtoasizeofEUR2.5Billion,where theelectromedicalproductshasanapproximateshareof50%.
Consumables and orthopedic devices/prosthesishave the leading share in the total medical deviceimportsduetothewideandmassuse.
However, electro medical products such asdiagnos[cmonitoring devices and other electronicequipment used for medical, surgical and dentalpurposes are gaining significance every year andincreasingtheirshareintotalimports.
Analyzing the electro medical products imports;diagnos[c monitoring, hemodialysis and otherelectronicdeviceshaveasignificantshareof68%inoverall electro medical product imports. It isfollowed byX, Alfa, Beta andGammaRayDeviceswithashareof20%.
22%
15%
14% 12%
9%
8%
7% 4%
9%
Consumables
Orthopedic Devices
Other Medical Devices Diagnostic Monitoring Devices Other Electronic Devices Glasses and Lenses
Dental Devices
Therapeutic Devices
Others
68%
20%
12%
Diagnostic Monitoring, Hemodialysis, etc.
X-Ray, etc.
Other Electro-medicals
Source: Turkish Statistical Institute
Supply of Electro Medicals: Imports
16
Yearlyimportvolumesofelectromedicalproductsaregiveninbelowchart,indica<ngayearlygrowthof8,4%,whichisalsoinlinewiththeexpectedgrowthofthemarket.
Highest growthwas experiences in X-Ray product imports with a CAGR of 16,7%, where the yearlygrowthofdiagnos<cmonitoring,hemodialysisandotherdeviceswas5,8%inthelast3years.
748 841 835
182 189 242 121 132 150
2013 2014 2015
EUR
Mill
ion
Diagnostic Monitoring, Hemodialisis X-Ray, etc. Other Electro-medicals
Source: Turkish Statistical Institute
Major Suppliers and Position of Italy
17
USA,GermanyandChinahavetheleadingshareinelectromedicalimportsmakinguparound54%ofthetotal.ThesecountrieshavelongyearsofpresenceinTurkishMarket,ac<velysupplyingtobothpublicandprivate healthcare ins<tu<ons. Compared to thesemarket leaders, Italy has a limited share of 4% andkeepsastablegrowth.
To increasetheirmarketshare, Italiansuppliersshouldclearly focusonalterna<vesalesanddistribu<onchannelsandac<velypar<cipateinpublictenderprocesses.
USA 22%
Germany 19%
China 13%
Japan 6%
Italy 4%
Others 36%
Source: Turkish Statistical Institute
Major Suppliers and Position of Italy
18
TradeinelectromedicalproductsbetweenItalyandTurkeyshowsthatTurkeyisanetimporterandthetrade balance indicates a stable growth in favor of Italy. Below analysis of Italian imports by productspresentstheopportuni<esforItaliansupplierstotargetcategorieswithlowmarketshare.
3,672 4,619 7,004
38,710 38,548 42,500
2013 2014 2015
1.00
0 EU
R
Export Import
Source: Turkish Statistical Institute
Major Suppliers: Importers and Distributors
19
Globally renowned companies are among the major players of medical device industry of Turkey assupplier.LeadingglobalmedicaldeviceproducershavechosenTurkeyfortheirregionalheadquarters,R&Dcenter(s)and/orfortheirproduc<onfacili<es.
Investment Support and Promotion Agency of Turkey 61 61
Major Players
• Leading global medical device producers have chosen Turkey for their regional headquarters, R&D center(s) and/or for their production facilities.
• Abbott and Siemens have production and R&D centers in Turkey, whereas Bayer and Alvimedica have corporate offices. GE has moved its headquarters for the EAGM region to Istanbul. Siemens opened a new production plant worth USD 76 Million to the Gebze Industrial Zone. Baxter has formed a partnership with Eczacıbaşı.
• Globally renowned companies are among the major players of medical device industry of Turkey as supplier.
• Some of these companies include Johnson & Johnson, Boston Scientific, CareFusion, Becton Dickinson & Company, Covidien, 3M, Philips and Olympus.
Investment Tip: Construction of new, city hospital complexes provide significant
opportunities for medical device companies that are being commissioned to equip the
facilities.
Investment Support and Promotion Agency of Turkey 61 61
Major Players
• Leading global medical device producers have chosen Turkey for their regional headquarters, R&D center(s) and/or for their production facilities.
• Abbott and Siemens have production and R&D centers in Turkey, whereas Bayer and Alvimedica have corporate offices. GE has moved its headquarters for the EAGM region to Istanbul. Siemens opened a new production plant worth USD 76 Million to the Gebze Industrial Zone. Baxter has formed a partnership with Eczacıbaşı.
• Globally renowned companies are among the major players of medical device industry of Turkey as supplier.
• Some of these companies include Johnson & Johnson, Boston Scientific, CareFusion, Becton Dickinson & Company, Covidien, 3M, Philips and Olympus.
Investment Tip: Construction of new, city hospital complexes provide significant
opportunities for medical device companies that are being commissioned to equip the
facilities.
Abbo_ and Siemenshave produc<on and R&D centers in Turkey,whereasBayer and Alvimedicahavecorporateoffices.GEhasmoveditsheadquartersfortheEAGMregiontoIstanbul.Siemensopenedanewproduc<onplantworthUSD76MillionintheGebzeIndustrialZone.BaxterhasformedapartnershipwithEczacıbaşı.
Major Suppliers: Importers and Distributors
20
Company Country DetailsBostonScien[fic USA Thecompanydoesnotmanufacturedevicesinthecountrybuthasarepresenta<veofficeinIstanbul.
Covidien IrelandThecompanyhasarepresenta<veoffice,CovidienSaglikA.S.İnIstanbul,butthereisnomanufacturingac<vity.Productsareimported.CovidienrecentlyestablishedaninovasioncenterinIstanbulwithaninvestmentofUSD21million.
Fresenius GermanyFreseniusMedikalHizmetlermanufacturesconcentratesforhaemodialysis.TheheadofficeisbasedinIstanbul.ThereareothersalesofficeslocatedinAnkara,IzmirandAdana.RevenuesamountedtoUSD75.5millionin2012.Freseniusoperates53dialysiscentresacrossTurkey,whichhavereceivedinvestmentofmorethanEUR125million.
GeneralElectric USASince2008,thecompanyhashadaninterna<onalofficeinIstanbulcoveringtheEAGMmarket(CentralAsia,MidddleEast,Africa,RussiaandCommonwealthofindependentstates,orCIS).InJune2009,thecompanyannouncedplanstoinvestinanewmedicalproduc<onplantinAnkara.Nofiguresorfurtherdetailsoftheinvestmentwereannounced.Thecompanymen<onedthattheproduc<onwillbegearedmainlyforexports.
Johnson&Johnson USA Thecompanyhasarepresenta<veoffice,Johnson&JohnsonProfessional,inIstanbul.Thereisnoknownmedical
deviceproduc<oninTurkey.
Medtronic USA-Ireland Thecompanyhasnomanufacturingplantorrepresenta<veofficeinthecountry;productsareimported.In2015,thecompanyacquiredCovidienandmoveditsheadquarterstoIreland.
Philips USA PhilipsHealthcareTurkiye(MedikalSistemler)isthemainrepresenta<veofficelocatedinIstanbul.Thereisnolocalmanufacturing,productsareimported.
Siemens Germany
SiemenshasastrongpresenceinTurkey.TheheadofficeisbasedinIstanbul,whichisalsotheloca<onfortwomanufacturingfacili<es,butthesedonotproducemedicaldevices.ThecompanyhasfourregionalofficesinBursa,Izmir,AnkaraandAdanaaswellassub-officesinMalatya,Trabzon,Kayseri,Gaziantep,Kocaeli,Konya,EskişehirandAntalya.In2012,SiemenssignedadealwithAcibademHospitalinAnkaratoprovidestate-of-the-artmedicalequipmentworthEUR9million,aspartofthehospital'srenova<onproject.SiemensalsocompletedprojectsforMoH,deliveringaCTpackageworthEUR5.4milllionandanagiography/X-raypackageworthEUR8.4million.Inaddi<on,akeyprojectwassignedwiththeAmericanHospitalinIstanbultoprovideaSOMATOMDefini<onCTDualSource.TheprojectisvaluedatEUR2.1million.
Smith&Nephew UK Thecompanyhanomanufacturingplantorrepresenta<veofficeinthecountry;productsareimported.
Stryker USA Thecompanyhanomanufacturingplantorrepresenta<veofficeinthecountry;productsareimported.
Opportunities in The Market
21
Thereareabout6,000companiesopera<ngintheTurkishmedicalequipmentanddevicesmarket.Thereare about 100 medical equipment manufacturers in the country, most of which are manufacturingdisposables, surgical tools, stents, prosthe<cs and hospital furniture. In general, all major categories ofmedical devices are present in the market both in private and public hospitals. At this point, theseins<tu<ons lookforstate-of-the-artand innova[ve,wherepossible,minimally invasiveornon-invasive,medicalequipmentandsolu<ons.Thereispoten<alforthefollowingmedicalequipment:
Advancedpre-screening,imaginganddiagnos[csdevices
Advancedpoint-of-caredevices
Advancedsurgicaldevicesusingrobo[cstechnology
Cancertreatmentdevices
Clinicalchemistryandlaboratorydevicesandreagents
E-healthandM-healthsystems
Implantsusedinorthopedicsandtrauma
Remotepa[entmonitoringdevices
Telemedicinesystems
Distribution Channels and Procurement Methods
22
Foreign Brand
Local Brand Rep. Office Importer/Distributor
Tender Process Direct Procurement
MoH Military Hospitals Private Sector
Primary/Secondary
Healthcare Units
University Hospitals
Distribution Channels and Procurement Methods
23
Significantweightofthepublicsectorinhealthcareindustryarisesdifferentsalesanddistribu<onschemescomparedtotheotherindustries,wheretheprivatesectordominates.
Majorcustomersofelectromedicalscanbegroupedas;Primary/SecondaryLevelHealthcareUnitsunderMoHmanagement,MoH (massprocurements),UniversityHospitals,MilitaryHospitals (underMinistryofDefensemanagement)andPrivateSector.
Ø Medicalequipmentanddevicesarepurchasedbyfamilyphysiciansworkinginprimarycareunits.Theequipmentordevicesarepurchasedthroughacompe[[vetenderingprocessorareleasedfromtheprivatesector.
Ø Medical devices and equipment for secondary and ter[ary levels of careare purchased or leasedthroughapubliccompe<<vetenderingprocess.
Ø As theMoHprocures a large number ofmedical devices and services for its facili<es, theMedicalDeviceServiceProcurementTendersModulehasbeenestablished fordetailedmonitoring. In2015,MoH signed a protocol with YOK (Council of Higher Educa<on) and started to supply UniversityHospitalsfortheirmedicalsupplyneeds.
Ø MilitaryHospitalsalsopurchasemedicaldevicesthroughacompe[[vetenderingprocess,which isfundedbyMinistryofDefense.
Ø PrivateHospitalsgenerallymakespurchasesthroughdirectprocurementmethod.
Regulatory Framework
24
AsamemberoftheEUCustomsUnion,TurkeyhasadoptedtheMedicalDevicesDirec[ve,theAc[veImplantableMedicalDevicesDirec[veandtheInVitroDiagnos[csDirec[vesoftheEU.Therefore,allproductsthataredeemedtofallundertheEUdirec<veswouldneedtoconformtothedirec<vesinordertobemanufacturedormarketedinTurkey.
Thus,TurkeyrecognizesEuropeanCEmarkingformedicaldevices.CEmarkingforallmedicaldevicesrequirestechnicaldocumenta<on,riskanalysis,proofofcompliancewiththeessen<alrequirementsofthedirec<ves,andaproductrelateddeclara<onofconformityissuedbythemanufacturer.
TheTurkishStandardsIns<tuteassessesandinspectsCEconformitybothforlocallyproducedproductsandimportedproducts.
TheDrugandDeviceIns[tute,whichisapartoftheMinistryofHealthinTurkeyisresponsibleforcer<fyingthatadevicemanufacturerhastakenstepstoensurecompliancewiththeregula[ons.
Allmedicaldevicesneedtoberegisteredinthena[onaldatabase(TITUBB)maintainedbytheDrugandDeviceIns<tute.
Publicprocurementlawsregulatethemajorityofservicesthatofferdiagnosisandcuresaswellasthepurchaseofdrugsandmedicalsupplies.ThePublicProcurementAuthorityoverseestheseac<vi<estoinsuretheyfollowtheregula<ons.
Regulatory Framework
25
• Medical Device Regulation (93/42/EEC) • Active Implantable Medical Device Regulation (90/385/EEC) • In Vitro Medical Diagnosis Devices Regulation (98/79/EC)
Medical Devices in the scope of;
• Declaration of Conformity • EC certification: given by a Notified Body authorized by EU
(exceptions: class I-other for MDR, IVD-other for IVMDDR). • Turkish translations of above documents. • Only a notification/online registration is required to Turkish Medicines
and Medical Devices National Databank to sell a medical device in Turkey.
• Manufacturers should place the medical devices in the market under their own name. If located abroad, should designate an Authorized Representative/distributor in Turkey.
Should hold a CE sign and should have;
Customs Duties
26
Customsdutyis0%fortheimportedelectromedicalproductsfromEUcountriesandtheVATrateis8%forthemajorityoftheproducts.Excep<onswith18%VATratearelistedbelowontheright.
Productswith18%VAT9019.10.10.00.159019.10.90.00.259019.20.00.00.259020.00.00.00.159020.00.00.00.189022.19.00.00.009022.29.00.00.009022.30.00.00.009022.90.00.10.009022.90.00.90.119022.90.00.90.129022.90.00.90.199402.10.00.00.199402.10.00.00.219402.90.00.00.21
Source: Ministry of Customs and Trade
CustomsCode Product CustomsDuty(EU) VAT
84.19.20 Medical,SurgicalorLaboratorySterilizers 0% 8%
9012 Microscopes,diffractapparatus,parts 0% 18%
9018Diagnos<c,surgical,dentalequipments
0% 8%
9019 Mech-ther,massage,psychtest,ozoneappequipments
0% 8%
9020 Breathingdevices,gasmasksandparts 0% 8%
9022 X,Alfa,BetaandGammaRaydevices,tubesandparts
0% 8%
9402 Medical,surgical,dentalorveterinaryfurnituresetc
0% 8%
Major Stakeholders in The Industry
27