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1、eeA1B2C3D4eA1B2C3D4eA1B2C3D4eA1B2C3D4eA1B2C3D4Global atlas of medical devices2022Global atlas of medical devices2022Global atlas of medical devices 2022ISBN 978-92-4-006220-7(electronic version)ISBN 978-92-4-006221-4(print version)World Health Organization 2022Some rights reserved.This work is avail

2、able under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence(CC BY-NC-SA 3.0 IGO;https:/creativecommons.org/licenses/by-nc-sa/3.0/igo).Under the terms of this licence,you may copy,redistribute and adapt the work for non-commercial purposes,provided the work is appropriately c

3、ited,as indicated below.In any use of this work,there should be no suggestion that WHO endorses any specific organization,products or services.The use of the WHO logo is not permitted.If you adapt the work,then you must license your work under the same or equivalent Creative Commons licence.If you c

4、reate a translation of this work,you should add the following disclaimer along with the suggested citation:“This translation was not created by the World Health Organization(WHO).WHO is not responsible for the content or accuracy of this translation.The original English edition shall be the binding

5、and authentic edition”.Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization(http:/www.wipo.int/amc/en/mediation/rules/).Suggested citation.Global atlas of medical devices 2022.Geneva:Wor

6、ld Health Organization;2022.Licence:CC BY-NC-SA 3.0 IGO.Cataloguing-in-Publication(CIP)data.CIP data are available at http:/apps.who.int/iris.Sales,rights and licensing.To purchase WHO publications,see http:/apps.who.int/bookorders.To submit requests for commercial use and queries on rights and lice

7、nsing,see https:/www.who.int/copyright.Third-party materials.If you wish to reuse material from this work that is attributed to a third party,such as tables,figures or images,it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyrigh

8、t holder.The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user.General disclaimers.The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part o

9、f WHO concerning the legal status of any country,territory,city or area or of its authorities,or concerning the delimitation of its frontiers or boundaries.Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement.The mention of specific compani

10、es or of certain manufacturers products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned.Errors and omissions excepted,the names of proprietary products are distinguished by initial capital letters.All reasonable precautio

11、ns have been taken by WHO to verify the information contained in this publication.However,the published material is being distributed without warranty of any kind,either expressed or implied.The responsibility for the interpretation and use of the material lies with the reader.In no event shall WHO

12、be liable for damages arising from its use.Graphic design and layout:Genve Design.A1B2C3D4A1B2C3D4A1B2C3D4A1B2C3D4A1B2C3D4iiiContentsAcknowledgements viiAcronyms and abbreviations viiiPreface ixMethodology xSources of the country profiles indicators xiCountry profiles .1Afghanistan -2Albania -4Alger

13、ia -6Andorra-8Angola -10Antigua and Barbuda -12Argentina -14Armenia-16Australia -18Austria -20Azerbaijan -22Bahamas -24Bahrain -26Bangladesh -28Barbados -30Belarus -32Belgium -34Belize -36Benin -38Bhutan -40Bolivia(Plurinational State of)-42Bosnia and Herzegovina -44Botswana -46Brazil -48Brunei Daru

14、ssalam -50Bulgaria -52Burkina Faso -54Burundi -56Cambodia -58Cameroon -60Canada -62Cabo Verde -64Central African Republic -66Chad -68Chile -70China -72Colombia -74Comoros -76Congo -78Cook Islands -80Costa Rica -82Cte dIvoire -84Croatia -86Cuba -88Cyprus -90Czechia -92Democratic Peoples Republic of K

15、orea -94Democratic Republic of the Congo -96Denmark -98Djibouti -100Dominica -102Dominican Republic-104ivGlobal atlas of medical devices 2022 Ecuador-106Egypt -108El Salvador -110Equatorial Guinea -112Eritrea -114Estonia -116Eswatini -118Ethiopia -120Fiji-122Finland -124France -126Gabon -128Gambia -

16、130Georgia -132Germany -134Ghana -136Greece -138Grenada-140Guatemala -142Guinea -144Guinea-Bissau-146Guyana -148Hati -150Honduras -152Hungary-154Iceland -156India -158Indonesia -160Iran(Islamic Republic of)-162Iraq -164Ireland -166Israel -168Italy -170Jamaica -172Japan -174Jordan -176Kazakhstan -178

17、Kenya -180Kiribati -182Kuwait -184Kyrgyzstan -186Lao Peoples Democratic Republic -188Latvia -190Lebanon -192Lesotho -194Liberia -196Libya -198Lithuania -200Luxembourg -202Madagascar -204Malawi -206Malaysia-208Maldives-210Mali -212Malta -214Marshall Islands -216Mauritania -218Mauritius -220Mexico -22

18、2Micronesia(Federated States of)-224Monaco-226Mongolia -228Montenegro -230Morocco -232Mozambique -234Myanmar -236Namibia-238Nauru -240Nepal -242Netherlands -244New Zealand -246Nicaragua -248Niger -250Nigeria -252A1B2C3D4A1B2C3D4A1B2C3D4A1B2C3D4A1B2C3D4vNiue -254North Macedonia -256Norway -258Oman -2

19、60Pakistan -262Palau -264Panama -266Papua New Guinea -268Paraguay -270Peru -272Philippines -274Poland -276Portugal-278Qatar -280Republic of Korea -282Republic of Moldova -284Romania -286Russian Federation -288Rwanda -290Saint Kitts and Nevis -292Saint Lucia -294Saint Vincent and the Grenadines -296S

20、amoa -298San Marino -300Sao Tome and Principe -302Saudi Arabia -304Senegal -306Serbia -308Seychelles -310Sierra Leone -312Singapore -314Slovakia -316Slovenia -318Solomon Islands -320Somalia -322South Africa -324South Sudan -326Spain -328Sri Lanka -330Sudan -332Suriname -334Sweden -336Switzerland -33

21、8Syrian Arab Republic -340Tajikistan -342Thailand-344Timor-Leste -346Togo -348Tonga -350Trinidad and Tobago-352Tunisia -354Trkiye -356Turkmenistan -358Tuvalu -360Uganda -362Ukraine -364United Arab Emirates -366United Kingdom of Great Britain and Northern Ireland -368United Republic of Tanzania -370U

22、nited States of America -372Uruguay-374Uzbekistan -376Vanuatu -378Venezuela(Bolivarian Republic of)-380Viet Nam -382Yemen -384Zambia -386Zimbabwe -388Annex 1-Additional comments -A1Annex 2 -Overview of no-menclature systems for medical devices in WHO member states -B1viGlobal atlas of medical device

23、s 2022 A1B2C3D4A1B2C3D4A1B2C3D4A1B2C3D4A1B2C3D4viiAcknowledgements In order to respond to the World Health Assembly resolution 60.26 on health technologies,particularly medical devices,WHO secretariat,Adriana Velazquez Berumen,Team lead for medical devices and in vitro diagnostics,coordinated the wo

24、rk on the first Baseline country survey on medical devices(under the Global Initiative on Health Technologies)as well as the resulting Global Atlas of medical devices in 2010.Since then,to keep the data up-to-date,she coordinated various re-launches of the survey whose results were published as coun

25、try profiles in book form and/or digital form on the WHO website in 2015 and 2017 and this present publication on 2022.The statistics are also found in the Global Health Observatory,where data has been updated after every edition.She worked in 2021,under the guidance from Dr Clive Ondari director of

26、 the Health Product Policy and Standards Department,and the leadership of Dr Mariangela Simao,Assistant Director General of the Access to Medicines and Health Products Division.WHO acknowledges and is most grateful to the consultants,country focal points in the Ministries of Health and WHO staff at

27、regional and country offices who dedicated their time and expertise to provide country data on medical devices.The survey was managed by Ricardo X.Martnez with the support of Heike Hufnagel and Valeria Montant.The analysis,evaluation,compilation,and verification of response data was coordinated and

28、implemented by Ricardo X.Martnez with the assistance of Heike Hufnagel,Lucero Lpez,Lucia Jimnez,Juan J.Lpez,David Lpez,Artiom Schepilov and Sebastin Losada.The search for and retrieval of the answers to the survey in Member States was a collaborative effort of the appointed health technology focal p

29、oints and/or the the medical device country focal points.The update of the country focal point contacts was possible thanks to the WHO regional advisers on health technologies,WHO health products focal points,and WHO representatives and liaison officers.Three desk-reviews in the medical device areas

30、“health technology assessment“(HTA),“nomenclature system”,and“regulatory agency”were accomplished in order to verify and complete the country data.They were coordinated by Ricardo X.Martnez and executed by Lucia Jimnez,Juan J.Lpez,David Lpez,Artiom Schepilov,and Lucero Lpez.Jani Mller,senior researc

31、her and board director of Health Technology Assessment International(HTAi),contributed in the HTA-related survey 2021 answer verification as well as in the corresponding HTA desk-review.Thanks also to the Economic Evaluation and Analysis,unit of WHO headquarters,specially to Andrew Mirelman,Kratu Go

32、el,and Tessa Edejer for their support in the HTA section.Two country-consultations in SeptemberNovember 2021 and AprilMay 2022,were done in order to verify the validity of the collected data.The outcome of these consultations was collected and updated by Olga Pineda,Daniela Rodriguez,and Lucia Jimne

33、z.Thanks to Riad F.Farah,Maurice Page,and Artiom Schepilov for their support in translating survey responses,emails and other communication in Arabic,French,and Russian language respectively.Thanks to WHO technical officers in the regional officers,as follows:Edith Annan,Diana Taguembou and Aissatou

34、 Sarassa,Regional Office for Africa;Alexandre Lemgruber,Nilda Enriquez,Regional Office for the Americas/Pan American Health Organization;Tifenn Lucile Humbert,Regional Office for Europe;Mohamad Wehbi,Regional Office for the Eastern Mediterranean;Stephen Himley,Regional Office for South-East Asia;Jin

35、ho Shin,Regional Office for the Western Pacific.Thanks to Daniela Rodriguez for her support in publishing this document by helping with the clearance,website creation,validation of indicator metadata and Jillian Reichenbach Ott for the data management.viiiGlobal atlas of medical devices 2022 Acronym

36、s and abbreviations CSoMD21 Country survey on medical devices 2020-2021FY21 Fiscal Year 2021EMDN European Medical Device NomenclatureGII Global Innovation IndexGNI gross national incomeGHO WHO Global Health Observatory GMDN Global Medical Device NomenclatureHDI Human Development IndexHTA health tech

37、nology assessment IAEA International Atomic Energy AgencyICT information,and communication technologyIDI ICT Development IndexITU International Telecommunication UnionIHDI inequality adjusted Human Development IndexIVDs in vitro diagnostics MOH Ministry of HealthMOR mortalityNCDs noncommunicable dis

38、easesOECD Organisation for Economic Co-operation and DevelopmentPOP populationSDGs Sustainable Development GoalsUHC Universal Health CoverageUMDNS Universal Medical Device Nomenclature SystemUN United NationsUN POP United Nations Population Division of the Department of Economic and Social AffairsWB

39、 World Bank WHO World Health Organization WHS World Health StatisticsWIPO World Intellectual Property OrganizationWPP World Population ProspectsA1B2C3D4A1B2C3D4A1B2C3D4A1B2C3D4A1B2C3D4ixPreface Health technologies are essential for a functioning health system.Medical devices in particular are crucia

40、l in the prevention,diagnosis,and treatment of disease as well as patient monitoring.Recognizing this important role of health technologies,the World Health Assembly adopted resolution WHA60.29 in May 2007.To determine the key areas that require support for the development or improvement of health t

41、echnology programs in countries and regions,the first WHO Baseline country survey on medical devices was launched in February 2010 by the WHO Department of Essential Health Technologies and resulted in the first set of country profiles conveying the situation of medical devices globally.The country

42、profiles were updated with a re-launch of the survey in November 2013 and since then,every 3 years,updates of the global medical device data have been published.In 2017 the Global Atlas of medical devices1 book was published containing 177 country profiles,an introduction to the medical device topic

43、s covered by the survey,and the corresponding facts,figures,and maps.From November 2020 until March 2021,and then from September 2021 to May 2022,the latest complete re-launch of the survey was carried out and its results are presented in this publication containing all 194 country profiles.It shoul

44、d be noted that the COVID-19 situation alerted the challenges presented by lack of priority or basic medical devices.This publication is intended for use as a reference by decision-makers in ministries of health,nongovernmental organizations and academic institutions involved in health technology at

45、 the district,national,regional or global levels.For a deeper understanding of the importance and standing in the health care domain of each of the surveys topics please refer to the document Global Atlas of medical devices-WHO medical devices technical series 2017 that addresses these in separate c

46、hapters.1 Global atlas of medical devices -WHO medical devices technical series”,ISBN 978 -92 -4 -151231 -2 World Health Organization 2017.xGlobal atlas of medical devices 2022 Methodology The 2020 re-launch of the 2010 Baseline country survey on medical devices was conceptualized and realized by th

47、e medical devices team.The appointed health technology focal points of 177 Member States2 and more than 500 country contacts,as well as WHO contacts and related contacts in the 17 countries without appointed focal points,were contacted by email in 4 different languages with a request to support and

48、coordinate either the update of the information already available in the previous atlas data or-in case of countries that had not answered the previous surveys-their first participation in the survey.Additionally,the medical devices team with the help of consultants,performed a web-based desk review

49、 of all countries to verify,update or newly include valid links to national websites regarding regulation,health technology assessment,and nomenclature.These efforts resulted in the final collection of all countries,either directly via nominated official health technology focal points i.e.179 countr

50、ies or indirectly via specific medical device country focal points.Results were analyzed,evaluated,compiled,and are now presented in this document in country profiles,together with additional information regarding the global and national medical device situations.The country profiles incorporate fac

51、ts indicating the national status of medical devices in areas such as:medical device policies,regulations,incorporation,lists,inventories,nomenclature,health technology assessment,management,and biomedical engineering resources.The focus of the 2021 edition of the Global Atlas is to point out how th

52、e status of medical device topics supports or hinders the accomplishment of the Sustainable Development Goals(SDGs)and supports the increased access to priority medical devices(including in vitro diagnostics)for emergencies,well being and universal health coverage(UCH).During the Information session

53、s on nomenclature of medical devices,Member States requested to extend the open consultation to review the Global Atlas.Therefore,consultations took place in 2021 and 2022 by posting in the WHO medical devices newsletter and in the nomenclature page.2 The countries health technology focal points wer

54、e nominated and their roles established in a two year effort upon the initiative of the WHO medical devices team in 2010.A1B2C3D4A1B2C3D4A1B2C3D4A1B2C3D4A1B2C3D4xiSources of the country profiles indicatorsIn the country profile there are four sections that contain indicators that may be taken from a

55、nother source other than the Country Survey of Medical Devices 2020-2021(CSoMD21)consultation.Among these sources we have the following:International Atomic Energy Agency:IAEA;Organisation for Economic Co-operation and Development OECD;and WHO Global Health Observatory:GHO.Here we specified each of

56、the indicators,as well as their definition,details and sources.Country indicators sectionTotal Population for all ages and both sexes(in millions):corresponding population of year 2020 medium estimates.World population prospects:the 2019 revision.POP/DB/WPP/Rev.2019/POP/F01-1.United Nations,Departme

57、nt of Economic and Social Affairs,Population Division(2019).World Population Prospects 2019,Online Edition,accessed June 2021.UNDP WPP 2019(2020 POP).World Bank Income group classification:(WB Income Classification)The World Bank assigns the worlds economies to four income groups:low,lower-middle,up

58、per-middle,and high-income countries.The classifications are updated each year on July 1 and are based on GNI per capita in current USD(using the Atlas method exchange rates)of the previous year(i.e.2021 in this case).In this publication the classification used corresponds to the Fiscal Year of 2023

59、:WB:FY23(data year:2021).Accessed October 2022.(The link provided updates the year classification each 1st of July,If it is the case you must refer to the historical WB income classification to find the fiscal year of 2023:FY23).Life expectancy at birth(years):The average number of years of life exp

60、ected by a hypothetical cohort of individuals who would be subject during all their lives to the mortality rates of a given period.It is expressed as years.UN:WPP 2019,MORT(data year:1990-2020).Accessed June 2022.Under-five mortality rate(per 1000 live births)(SDG 3.2.1):Probability of dying by age

61、5 per 1000 live births.WHO Global Health Observatory(GHO)data.UN-IGME,SDG 3.2.1(data year:2020).Accessed October 2022.Probability of dying 30-70 of NCDs(SDG 3.4.1):probability of dying between age 30 and exact age 70 years from any of cardiovascular disease,cancer,diabetes,or chronic respiratory dis

62、ease.WHO Global Health Observatory(GHO)data.WHO:GHO,SDG 3.4.1(data year:2019).Accessed October 2022.Human Development Index(HDI):This a summary measure of average achievement in key dimensions of human development:a long and healthy life(life expectancy at birth),being knowledgeable(education dimens

63、ion measured by mean of years of schooling for adults aged years and more and expected years of schooling for children of school entering age),and have a decent standard of living(measured by gross national income per capita).Inequality adjusted HDI(IHDI):adjusts the HDI for inequality in the distri

64、bution of each of the three dimensions across the population.UNDP:HDR 2019/20,HDI and IHDI(data year:2019).Accessed June 2022.HDI and IHDI technical notesxiiGlobal atlas of medical devices 2022 Information,communication technology(ICT)Development Index(IDI):is a composite index combining eleven indi

65、cators into one benchmark measure that serves to monitor and compare developments in ICT between countries and over time.It is composed by 3 ICT related components:readiness(infrastructure,access),use(intensity),and capability(skills).ITU:IDI 2017(data year:2017).Accessed June 2022.IDI methodology.S

66、ervice coverage Index(SDG 3.8.1):average coverage of essential services based on tracer interventions that include reproductive,maternal,newborn and child health,infectious diseases,non-communicable diseases and service capacity and access,among the general and the most disadvantaged population.WHO

67、Global Health Observatory(GHO)data.WHO:GHO,SDG 3.8.1(data year:2019).Accessed June 2022.Percentage of the population with out-of-pocket health spending exceeding 10%or 25%of the household expenditure/budget/income:(SDG 3.8.2).WHO Global Health Observatory(GHO)data.WHO:GHO,SDG 3.8.2,10%(data year:lat

68、est 2010-18)and WHO:GHO,SDG 3.8.2,25%(data year:latest 2010-18).Both accessed June 2022.Global Innovation Index(GII):Is an annual ranking of countries by their capacity for,and success in,innovation.It is computed by taking a simple average of the scores in two sub-indices,the Innovation Input Index

69、 and Innovation Output Index,which are composed of five and two pillars respectively.Each of these pillars describes an attribute of innovation.Each pillar is divided into three sub-pillars,each of which is composed of individual indicators,a total of 80 indicators are in GII 2020 exploring a broad

70、vision of innovation,including political environment,education,infrastructure and business sophistication.WIPO:GII(data year:2020).Accessed June 2022.GII Conceptual FrameworkHigh-technology exports(%of manufactured exports):Are products with high R&D intensity,such as in aerospace,computers,pharmace

71、uticals,scientific instruments,and electrical machinery.UN-WB:HtE(data year:latest 2017-19).Accessed June 2022.National health technology assessment unit sectionDesignated unit/department for health technology assessment(HTA):states if the country country has a systematic formal process by which inf

72、ormation is gathered to support healthcare decision-making at a national level(options:Yes or No).Latest country data during the period 2015 to 2021 from one of the following sources:WHO:HTA&HBP 2021 survey,WHO:HTA 2015 survey;and WHO CSoMD21.Both accessed June 2022.Medical device nomenclature syste

73、m sectionOfficial nomenclature system for medical devices:states if the country has reported having an official nomenclature system for medical devices(options:Yes or No).Type of nomenclature system for medical devices:states the reported type of official nomenclature system by the country.The follo

74、wing seven nomenclature categories were taken into account:1:Based on GMDN(Global Medical Device Nomenclature);2:Based on UMDNS(Universal Medical Device Nomenclature System);3:Based on EMDN(European Medical Device Nomenclature System)4:Nationally developed 5:Based on more than one system;6:Other;7:N

75、one.“Based on”wording should be interpreted as includes original dataset or modified version.Use of nomenclature system for medical devices states:the reported specific use of the official nomenclature system by the country.The following five categories of specific uses were taken into account:1:For

76、 regulatory purposes;2:For procurement purposes;3:For regulatory and procurement purposes;4:For various purposes;5:Not specified.eA1B2C3D4A1B2C3D4A1B2C3D4A1B2C3D4A1B2C3D4A1B2C3D4xiiiThe first version of data collection related to medical devices,the Country Survey of Medical Devices(CSoMD),was carri

77、ed out during the 20102013 period.Thereafter,in the 20142017 and 20202021 periods,data relating to medical devices was collected in what has now been referred to as the Country Survey(2020).The Global Atlas of Medical Devices 2022 data collection was reviewed and updated if necessary,at the request

78、of the Member States,in an open consultation that lasted from September 2021 to May 2022,referred to as Nomenclature and Global Atlas consultations(20212022).Medical equipment sectionDensity of magnetic resonance imaging units(per million population):number of Magnetic Resonance(MRI)units from the p

79、ublic and private sectors,per million population(UN:WPP 2019,POP(data year:2020).Latest country data during the period 2013 to 2021 from one of the following sources:WHO CSoMD21,WHO:GHO,MD:MRI,and OECD,HE database(2017-19).Both accessed June 2022.Density of computed tomography units(per million popu

80、lation):number of Computed tomography(CT)scan units from the public and private sectors,per million population(UN:WPP 2019,POP(data year:2020).Latest country data during the period 2013 to 2021 from one of the following sources:WHO CSoMD21,WHO:GHO,MD:CT,and OECD,HE database(2017-19).Both accessed Ju

81、ne 2022.Density of positron emission tomography units(per million population):number of Positron emission tomography(PET)units from the public and private sectors,per million population(UN:WPP 2019,POP(data year:2020).Latest country data during the period 2013 to 2021 from one of the following sourc

82、es:WHO CSoMD21,WHO:GHO,MD:PET,and OECD,HE database(2017-19).Both accessed June 2022.Density of gamma camera or nuclear medicine units(per million population):number of Gamma camera or Nuclear medicine units from the public and private sectors,per million population(UN:WPP 2019,POP(data year:2020).La

83、test country data during the period 2013 to 2021 from one of the following sources:CSoMD21,WHO:GHO,MD:GC-NC,and OECD,HE database(2017-19).Both accessed June 2022.Density of mammographs(per million females aged between 50 and 69 years old):Number of mammographs units from the public and private secto

84、rs,per million population(UN:WPP 2019,POP(data year:2020).Latest country data during the period 2013 to 2021 from one of the following sources:WHO CSoMD21 and WHO:GHO,MD:MAM,and OECD,HE database(2017-19).Both accessed June 2022.Density of radiotherapy units(per million population):number of radiothe

85、rapy units(RU)including the following:circular and linear accelerators(LINAC),Radionuclide teletherapy units,Brachytherapy units,proton ion therapy or particle accelerators,and X-Ray generators(as defined by IAEA);per million population(UN:WPP 2019,POP(data year:2020).Latest country data during the

86、period 2013 to 2021 from the latest available of the following sources:WHO CSoMD21;WHO:GHO,RU and IAEA:DIRAC database(2017-21).Both accessed June 2022.Medical devices workforce sectionNumber of biomedical/clinical engineers professionals in the country:Number of biomedical engineers(holding the corr

87、esponding university degree).Latest country data during the period 2017 to 2021 from the latest available of the following sources:CSoMD21;and WHO:GHO,HW.Accessed October 2022.A1B2C3D4A1B2C3D4A1B2C3D4A1B2C3D4A1B2C3D4xivGlobal atlas of medical devices 2022 A1B2C3D4A1B2C3D4A1B2C3D4A1B2C3D4A1B2C3D4Coun

88、try profilesGlobal atlas of medical devices 2022 2AfghanistanCountry indicators -WHO country informationNational policy on health technologyHealth technology(medical device)national policy:NoPolicy is part of the National Health Program/Plan:NoWebsite:Language(s):Ministry of health responsible for h

89、ealth technology policy implementation:National lists of medical devicesNational list of approved priority/essential medical devices,(including IVDs),for procurement or reimbursement:Lists available:Yes,but it is only a recommendationUnit:Website:Nomenclature systems used for devices and tests:Natio

90、nal list for different types of healthcare facilities (hospitals,laboratories,etc)Lists available:NoWebsite-hospitals:Website-laboratories:Nomenclature systems used for devices and tests:National list for specific clinical interventions/emergencies:Lists available:NoWebsite:National health technolog

91、y assessment unitDesignated unit/department for health technology assessment(HTA):NoHTA unit/department includes the assessment of medical devices:NoUnit/department:Website(s):Contact:Email:Committee includes a biomedical or clinical engineer:National regulatory authorityPresence of national authori

92、ty responsible for regulating medical devices:YesName of regulatory agency:General Directorate Pharmaceutical Affairs,Ministry of Public Health(MoPH).Website(s):http:/moph.gov.af/enContact:Mr.Abdul Hafiz Quraishi Email:Name(s)of other regulatory agency eg.for radiation equipment etc.:Other agencys w

93、ebsite:Population 000s(rank):a38,928(37)World Bank income group:bLowLife expectancy at birth(years):cYearsApproved devices lists comments(.Annex 1):Health care facilities lists comments (.Annex 1):Specific lists comments(.Annex 1):eHTA unit comments(.Annex 1):The National HTA unit is not yet establi

94、shed.National regulatory comments (.Annex 1):Under-five mortality(per 1000 live births):d57.98UHC-Service coverage index(1-100):h37Probability of dying aged 30-70 yrs from the 4 major NCDs(%):e35.30%UHC-Population with household spending 10%(25%)of corresponding income(%):i14.6%(2.0%)Human Developme

95、nt Index(inequality adjusted HDI):rank:f0.51():lowGlobal innovation index(rank):j()ICT Development Index(rank):g2(159)High-technology exports(%of manufacture exports):k 3a UN:WPP 2019,POP(data year:2020)b WB:FY23(data year:2021)c UN:WPP 2019,MORT(data year:1990-2020)d UN-IGME,SDG 3.2.1(data year:202

96、0)e WHO:GHO,SDG 3.4.1(data year:2019)f UNDP:HDR 2019/20,HDI and IHDI(data year:2019)g ITU:IDI 2017(data year:2017)h WHO:GHO,SDG 3.8.1(data year:2019)i WHO:GHO,SDG 3.8.2,10%or 25%(data year:latest 2010-18)j WIPO:GII(data year:2020)k UN-WB:HtE(data year:latest 2017-19)WHO:HTA&HBP 20/21 survey,HTA 2015

97、,CSoMD21(data year:latest 2015 or 2021)WHO:GHO,ME;OECD,HE;CSoMD21(data year:latest 2013-21)WHO:GHO,RU;IAEA:DIRAC;CSoMD21(data year:latest 2013-21)WHO:GHO,HW;CSoMD21(data year:latest 2017-2021)n/a not applicable/not availableMedical device nomenclature systemOfficial nomenclature system for medical d

98、evices:No Type:None Use:Not specifiedWebsite:Medical device incorporationProcurementPolicy or guideline:No Website:National level procurement:No Website:DonationsPolicy or guideline:No Website:Technical specificationsTechnical specifications to support procurement or donations:YesPublically availabl

99、e:NoWebsite:Medical equipment management unitUnit present:Yes Professionally trained biomedical/clinical engineers:YesUnit/Department:Radiology,Ministry of Public Health.Unit website:Contact name:Mr.Mirza Said Hashimi Contact email:Website with publically available technical specifications:Number of

100、 regional/state offices/units:0Inventories and medical equipment management software Type of inventories available:National inventory for medical equipmentWebsite:Use of management software:No Software name:Medical devices workforceNumber of biomedical/clinical engineers professionals in the country

101、:10%(25%)of corresponding income(%):i16.7%(5.0%)Human Development Index(inequality adjusted HDI):rank:f0.8(0.71):highGlobal innovation index(rank):j27.1(83)ICT Development Index(rank):g5.1(89)High-technology exports(%of manufacture exports):k 0.00%5a UN:WPP 2019,POP(data year:2020)b WB:FY23(data yea

102、r:2021)c UN:WPP 2019,MORT(data year:1990-2020)d UN-IGME,SDG 3.2.1(data year:2020)e WHO:GHO,SDG 3.4.1(data year:2019)f UNDP:HDR 2019/20,HDI and IHDI(data year:2019)g ITU:IDI 2017(data year:2017)h WHO:GHO,SDG 3.8.1(data year:2019)i WHO:GHO,SDG 3.8.2,10%or 25%(data year:latest 2010-18)j WIPO:GII(data y

103、ear:2020)k UN-WB:HtE(data year:latest 2017-19)WHO:HTA&HBP 20/21 survey,HTA 2015,CSoMD21(data year:latest 2015 or 2021)WHO:GHO,ME;OECD,HE;CSoMD21(data year:latest 2013-21)WHO:GHO,RU;IAEA:DIRAC;CSoMD21(data year:latest 2013-21)WHO:GHO,HW;CSoMD21(data year:latest 2017-2021)n/a not applicable/not availa

104、bleMedical device nomenclature systemOfficial nomenclature system for medical devices:Yes Type:Nationally developed Use:For procurement purposesWebsite:Medical device incorporationProcurementPolicy or guideline:Yes Website:National level procurement:Yes Website:DonationsPolicy or guideline:Yes Websi

105、te:Technical specificationsTechnical specifications to support procurement or donations:NoPublically available:Website:Medical equipment management unitUnit present:Yes Professionally trained biomedical/clinical engineers:YesUnit/Department:Unit for the Management of Medical Devices.Unit website:Con

106、tact name:Ms.Ledina Picari Contact email:lpicarimoh.gov.alWebsite with publically available technical specifications:Number of regional/state offices/units:4Inventories and medical equipment management software Type of inventories available:National inventory for medical equipmentWebsite:Use of mana

107、gement software:Yes Software name:Clingo.Medical devices workforceNumber of biomedical/clinical engineers professionals in the country:55ContactsNational officer(s):Name:Email:Name:Ms.Ledina PicariEmail:lpicarimoh.gov.alGeneral comments(.Annex 1):Concerning the HT national policy,the following docum

108、ent was provided:http:/www.who.int/medical_devices/survey_resources/health_technology_national_policy_albania.pdfA1B2C3D4Nomenclature comments(.Annex 1):This italian nomenclature system CIVAB comes with the Inventory system called CLINGO.Medical device incorporation comments(.Annex 1):It exists the

109、National Policy for management of medical devices in Albania.The procurement of medical devices at national levels is done partially.Medical equipmentTotalDensity per 1,000,000 populationMagnetic Resonance Imaging:51.58Computerized Tomography Scanner:175.36Positron Emission Tomography Scanner:00Gamm

110、a camera or nuclear medicine:00Mammograph:,*1854.4Radiotherapy:62.08*Density per 1,000,000 females aged from 50-69 old.Software comments(.Annex 1):The inventory system is called CLINGO.The National Biomedical Centre manages the system.Each hospital(13 regional hospitals are involved)is in charge of

111、adding their own data.It doesnt cover all the hospitals and other public health institutions.WHO Country officer(s):Name:Dr.Gerald RockenschaubEmail:rockenschaubgwho.intName:Email:WHO European RegionAlbaniaGlobal atlas of medical devices 2022 6AlgeriaCountry indicators -WHO country informationNation

112、al policy on health technologyHealth technology(medical device)national policy:YesPolicy is part of the National Health Program/Plan:NoWebsite:http:/www.sante.gov.dz/communiques/82-documentation/455-programmes-d-importation-des-produits-pharmaceutiques.htmlLanguage(s):FranaisMinistry of health respo

113、nsible for health technology policy implementation:Direction Gnrale de la Pharmacie.National lists of medical devicesNational list of approved priority/essential medical devices,(including IVDs),for procurement or reimbursement:Lists available:NoUnit:Website:Nomenclature systems used for devices and

114、 tests:National list for different types of healthcare facilities (hospitals,laboratories,etc)Lists available:NoWebsite-hospitals:Website-laboratories:Nomenclature systems used for devices and tests:National list for specific clinical interventions/emergencies:Lists available:NoWebsite:National heal

115、th technology assessment unitDesignated unit/department for health technology assessment(HTA):NoHTA unit/department includes the assessment of medical devices:NoUnit/department:Website(s):Contact:Email:Committee includes a biomedical or clinical engineer:National regulatory authorityPresence of nati

116、onal authority responsible for regulating medical devices:YesName of regulatory agency:Ministre de la sant,de la Population et de la Rforme Hospitalire.Website(s):www.sante.gov.dzContact:Dr.Hamou Hafed Email:dgpharmaciesante.dzName(s)of other regulatory agency eg.for radiation equipment etc.:Algeria

117、n Atomic Energy Commission(Comena).Other agencys website:https:/www.aps.dz/en/algeria/tag/Atomic%20Energy%20CommissionPopulation 000s(rank):a43,851(33)World Bank income group:bLower-MiddleLife expectancy at birth(years):cYearsApproved devices lists comments(.Annex 1):Health care facilities lists com

118、ments (.Annex 1):Specific lists comments(.Annex 1):eHTA unit comments(.Annex 1):Adopted EMA(European Medicines Agency)and ICH(International Council for Harmonisation for Pharmaceuticals)guidelines.Inspector General Office performs health economics HTA.Within the MoH HTA is focused on pharmaceutics b

119、ut not in medical devices.National regulatory comments (.Annex 1):Under-five mortality(per 1000 live births):d22.68UHC-Service coverage index(1-100):h75Probability of dying aged 30-70 yrs from the 4 major NCDs(%):e13.90%UHC-Population with household spending 10%(25%)of corresponding income(%):i()Hum

120、an Development Index(inequality adjusted HDI):rank:f0.75(0.6):highGlobal innovation index(rank):j19.5(121)ICT Development Index(rank):g4.7(102)High-technology exports(%of manufacture exports):k 1.00%7a UN:WPP 2019,POP(data year:2020)b WB:FY23(data year:2021)c UN:WPP 2019,MORT(data year:1990-2020)d U

121、N-IGME,SDG 3.2.1(data year:2020)e WHO:GHO,SDG 3.4.1(data year:2019)f UNDP:HDR 2019/20,HDI and IHDI(data year:2019)g ITU:IDI 2017(data year:2017)h WHO:GHO,SDG 3.8.1(data year:2019)i WHO:GHO,SDG 3.8.2,10%or 25%(data year:latest 2010-18)j WIPO:GII(data year:2020)k UN-WB:HtE(data year:latest 2017-19)WHO

122、:HTA&HBP 20/21 survey,HTA 2015,CSoMD21(data year:latest 2015 or 2021)WHO:GHO,ME;OECD,HE;CSoMD21(data year:latest 2013-21)WHO:GHO,RU;IAEA:DIRAC;CSoMD21(data year:latest 2013-21)WHO:GHO,HW;CSoMD21(data year:latest 2017-2021)n/a not applicable/not availableMedical device nomenclature systemOfficial nom

123、enclature system for medical devices:No Type:None Use:Not specifiedWebsite:Medical device incorporationProcurementPolicy or guideline:Yes Website:National level procurement:Yes Website:DonationsPolicy or guideline:No Website:Technical specificationsTechnical specifications to support procurement or

124、donations:NoPublically available:Website:Medical equipment management unitUnit present:Professionally trained biomedical/clinical engineers:NoUnit/Department:Sous direction de lenregistrement des produits pharmaceutiques.Unit website:www.sante.gov.dzContact name:Dr.Soumia Yahiaoui Contact email:Webs

125、ite with publically available technical specifications:Number of regional/state offices/units:Inventories and medical equipment management software Type of inventories available:Website:Use of management software:No Software name:Medical devices workforceNumber of biomedical/clinical engineers profe

126、ssionals in the country:10%(25%)of corresponding income(%):i()Human Development Index(inequality adjusted HDI):rank:f0.87():very highGlobal innovation index(rank):j()ICT Development Index(rank):g7.7(30)High-technology exports(%of manufacture exports):k 28.50%9a UN:WPP 2019,POP(data year:2020)b WB:FY

127、23(data year:2021)c UN:WPP 2019,MORT(data year:1990-2020)d UN-IGME,SDG 3.2.1(data year:2020)e WHO:GHO,SDG 3.4.1(data year:2019)f UNDP:HDR 2019/20,HDI and IHDI(data year:2019)g ITU:IDI 2017(data year:2017)h WHO:GHO,SDG 3.8.1(data year:2019)i WHO:GHO,SDG 3.8.2,10%or 25%(data year:latest 2010-18)j WIPO

128、:GII(data year:2020)k UN-WB:HtE(data year:latest 2017-19)WHO:HTA&HBP 20/21 survey,HTA 2015,CSoMD21(data year:latest 2015 or 2021)WHO:GHO,ME;OECD,HE;CSoMD21(data year:latest 2013-21)WHO:GHO,RU;IAEA:DIRAC;CSoMD21(data year:latest 2013-21)WHO:GHO,HW;CSoMD21(data year:latest 2017-2021)n/a not applicable

129、/not availableMedical device nomenclature systemOfficial nomenclature system for medical devices:Type:Use:Website:Medical device incorporationProcurementPolicy or guideline:Website:National level procurement:Website:DonationsPolicy or guideline:Website:Technical specificationsTechnical specification

130、s to support procurement or donations:Publically available:Website:Medical equipment management unitUnit present:Professionally trained biomedical/clinical engineers:Unit/Department:Unit website:Contact name:Contact email:Website with publically available technical specifications:Number of regional/

131、state offices/units:Inventories and medical equipment management software Type of inventories available:Website:Use of management software:Software name:Medical devices workforceNumber of biomedical/clinical engineers professionals in the country:ContactsNational officer(s):Name:Email:Name:Email:Gen

132、eral comments(.Annex 1):A1B2C3D4Nomenclature comments(.Annex 1):Medical device incorporation comments(.Annex 1):Medical equipmentTotalDensity per 1,000,000 populationMagnetic Resonance Imaging:n/an/aComputerized Tomography Scanner:n/an/aPositron Emission Tomography Scanner:n/an/aGamma camera or nucl

133、ear medicine:n/an/aMammograph:,*n/an/aRadiotherapy:n/an/a*Density per 1,000,000 females aged from 50-69 old.Software comments(.Annex 1):WHO Country officer(s):Name:Email:Name:Email:WHO European RegionAndorraGlobal atlas of medical devices 2022 10AngolaCountry indicators -WHO country informationNatio

134、nal policy on health technologyHealth technology(medical device)national policy:NoPolicy is part of the National Health Program/Plan:NoWebsite:Language(s):Ministry of health responsible for health technology policy implementation:National lists of medical devicesNational list of approved priority/es

135、sential medical devices,(including IVDs),for procurement or reimbursement:Lists available:NoUnit:Website:Nomenclature systems used for devices and tests:National list for different types of healthcare facilities (hospitals,laboratories,etc)Lists available:YesWebsite-hospitals:Website-laboratories:No

136、menclature systems used for devices and tests:National list for specific clinical interventions/emergencies:Lists available:NoWebsite:National health technology assessment unitDesignated unit/department for health technology assessment(HTA):NoHTA unit/department includes the assessment of medical de

137、vices:NoUnit/department:Website(s):Contact:Email:Committee includes a biomedical or clinical engineer:National regulatory authorityPresence of national authority responsible for regulating medical devices:YesName of regulatory agency:Agncia Reguladora de Medicamentos e Tecnologias de Sade(ARMED)Webs

138、ite(s):Contact:Dr.Boaventura Moura Email:Name(s)of other regulatory agency eg.for radiation equipment etc.:Other agencys website:Population 000s(rank):a32,866(44)World Bank income group:bLower-MiddleLife expectancy at birth(years):cYearsApproved devices lists comments(.Annex 1):Health care facilitie

139、s lists comments (.Annex 1):Specific lists comments(.Annex 1):eHTA unit comments(.Annex 1):National regulatory comments (.Annex 1):June 4,2021:With Presidential Decree 136/21 the extinction of the Direco Nacional de Medicamentos e Equipamentos is announced and the Regulatory Agency for Medicines and

140、 Health Technologies(ARMED)is created,which will have its headquarters in Luanda,Angola and will be supervised by the Ministry of Health.Under-five mortality(per 1000 live births):d71.47UHC-Service coverage index(1-100):h39Probability of dying aged 30-70 yrs from the 4 major NCDs(%):e22.30%UHC-Popul

141、ation with household spending 10%(25%)of corresponding income(%):i()Human Development Index(inequality adjusted HDI):rank:f0.58(0.4):mediumGlobal innovation index(rank):j()ICT Development Index(rank):g1.9(160)High-technology exports(%of manufacture exports):k 5.80%11a UN:WPP 2019,POP(data year:2020)

142、b WB:FY23(data year:2021)c UN:WPP 2019,MORT(data year:1990-2020)d UN-IGME,SDG 3.2.1(data year:2020)e WHO:GHO,SDG 3.4.1(data year:2019)f UNDP:HDR 2019/20,HDI and IHDI(data year:2019)g ITU:IDI 2017(data year:2017)h WHO:GHO,SDG 3.8.1(data year:2019)i WHO:GHO,SDG 3.8.2,10%or 25%(data year:latest 2010-18

143、)j WIPO:GII(data year:2020)k UN-WB:HtE(data year:latest 2017-19)WHO:HTA&HBP 20/21 survey,HTA 2015,CSoMD21(data year:latest 2015 or 2021)WHO:GHO,ME;OECD,HE;CSoMD21(data year:latest 2013-21)WHO:GHO,RU;IAEA:DIRAC;CSoMD21(data year:latest 2013-21)WHO:GHO,HW;CSoMD21(data year:latest 2017-2021)n/a not app

144、licable/not availableMedical device nomenclature systemOfficial nomenclature system for medical devices:No Type:None Use:Not specifiedWebsite:Medical device incorporationProcurementPolicy or guideline:No Website:National level procurement:Yes Website:DonationsPolicy or guideline:No Website:Technical

145、 specificationsTechnical specifications to support procurement or donations:NoPublically available:Website:Medical equipment management unitUnit present:Professionally trained biomedical/clinical engineers:NoUnit/Department:Unit website:Contact name:Mr.Elisio de Carvalho Contact email:.brWebsite wit

146、h publically available technical specifications:Number of regional/state offices/units:Inventories and medical equipment management software Type of inventories available:Website:Use of management software:No Software name:Medical devices workforceNumber of biomedical/clinical engineers professional

147、s in the country:ContactsNational officer(s):Name:Mr.Elisio de CarvalhoEmail:.brName:Email:General comments(.Annex 1):A1B2C3D4Nomenclature comments(.Annex 1):Medical device incorporation comments(.Annex 1):Medical equipmentTotalDensity per 1,000,000 populationMagnetic Resonance Imaging:10.05Computer

148、ized Tomography Scanner:90.42Positron Emission Tomography Scanner:00Gamma camera or nuclear medicine:00Mammograph:,*56.33Radiotherapy:40.12*Density per 1,000,000 females aged from 50-69 old.Software comments(.Annex 1):WHO Country officer(s):Name:Dr.Djamila Khady CabralEmail:cabraldwho.intName:Email:

149、WHO African RegionAngolaGlobal atlas of medical devices 2022 12Antigua and BarbudaCountry indicators -WHO country informationNational policy on health technologyHealth technology(medical device)national policy:NoPolicy is part of the National Health Program/Plan:NoWebsite:Language(s):Ministry of hea

150、lth responsible for health technology policy implementation:National lists of medical devicesNational list of approved priority/essential medical devices,(including IVDs),for procurement or reimbursement:Lists available:NoUnit:Website:Nomenclature systems used for devices and tests:National list for

151、 different types of healthcare facilities (hospitals,laboratories,etc)Lists available:NoWebsite-hospitals:Website-laboratories:Nomenclature systems used for devices and tests:National list for specific clinical interventions/emergencies:Lists available:NoWebsite:National health technology assessment

152、 unitDesignated unit/department for health technology assessment(HTA):HTA unit/department includes the assessment of medical devices:NoUnit/department:Website(s):Contact:Email:Committee includes a biomedical or clinical engineer:National regulatory authorityPresence of national authority responsible

153、 for regulating medical devices:NoName of regulatory agency:Website(s):Contact:Email:Name(s)of other regulatory agency eg.for radiation equipment etc.:Other agencys website:Population 000s(rank):a98(183)World Bank income group:bHighLife expectancy at birth(years):cYearsApproved devices lists comment

154、s(.Annex 1):Health care facilities lists comments (.Annex 1):Specific lists comments(.Annex 1):eHTA unit comments(.Annex 1):National regulatory comments (.Annex 1):Under-five mortality(per 1000 live births):d6.39UHC-Service coverage index(1-100):h72Probability of dying aged 30-70 yrs from the 4 majo

155、r NCDs(%):e17.60%UHC-Population with household spending 10%(25%)of corresponding income(%):i()Human Development Index(inequality adjusted HDI):rank:f0.78():highGlobal innovation index(rank):j()ICT Development Index(rank):g5.7(76)High-technology exports(%of manufacture exports):k 0.60%13a UN:WPP 2019

156、,POP(data year:2020)b WB:FY23(data year:2021)c UN:WPP 2019,MORT(data year:1990-2020)d UN-IGME,SDG 3.2.1(data year:2020)e WHO:GHO,SDG 3.4.1(data year:2019)f UNDP:HDR 2019/20,HDI and IHDI(data year:2019)g ITU:IDI 2017(data year:2017)h WHO:GHO,SDG 3.8.1(data year:2019)i WHO:GHO,SDG 3.8.2,10%or 25%(data

157、 year:latest 2010-18)j WIPO:GII(data year:2020)k UN-WB:HtE(data year:latest 2017-19)WHO:HTA&HBP 20/21 survey,HTA 2015,CSoMD21(data year:latest 2015 or 2021)WHO:GHO,ME;OECD,HE;CSoMD21(data year:latest 2013-21)WHO:GHO,RU;IAEA:DIRAC;CSoMD21(data year:latest 2013-21)WHO:GHO,HW;CSoMD21(data year:latest 2

158、017-2021)n/a not applicable/not availableMedical device nomenclature systemOfficial nomenclature system for medical devices:No Type:None Use:Not specifiedWebsite:Medical device incorporationProcurementPolicy or guideline:No Website:National level procurement:Yes Website:DonationsPolicy or guideline:

159、No Website:Technical specificationsTechnical specifications to support procurement or donations:NoPublically available:Website:Medical equipment management unitUnit present:Yes Professionally trained biomedical/clinical engineers:YesUnit/Department:Unit website:Contact name:Contact email:Website wit

160、h publically available technical specifications:Number of regional/state offices/units:0Inventories and medical equipment management software Type of inventories available:NoneWebsite:Use of management software:Software name:Medical devices workforceNumber of biomedical/clinical engineers profession

161、als in the country:ContactsNational officer(s):Name:Mr.St.Clair A.SoleynEmail:Name:Email:General comments(.Annex 1):A1B2C3D4Nomenclature comments(.Annex 1):Medical device incorporation comments(.Annex 1):Medical equipmentTotalDensity per 1,000,000 populationMagnetic Resonance Imaging:111.11Computeri

162、zed Tomography Scanner:222.23Positron Emission Tomography Scanner:n/an/aGamma camera or nuclear medicine:n/an/aMammograph:,*2272.15Radiotherapy:110.2*Density per 1,000,000 females aged from 50-69 old.Software comments(.Annex 1):WHO Country officer(s):Name:Dra.Amalia Del RiegoEmail:delriegoapaho.orgN

163、ame:Dr.Cecilia AcunaEmail:acunamarpaho.orgWHO Region of the AmericasAntigua and BarbudaGlobal atlas of medical devices 2022 14ArgentinaCountry indicators -WHO country informationNational policy on health technologyHealth technology(medical device)national policy:YesPolicy is part of the National Hea

164、lth Program/Plan:YesWebsite:https:/www.argentina.gob.ar/anmatLanguage(s):EspaolMinistry of health responsible for health technology policy implementation:Secretara de Calidad en Salud-Ministerio de SaludNational lists of medical devicesNational list of approved priority/essential medical devices,(in

165、cluding IVDs),for procurement or reimbursement:Lists available:YesUnit:Instituto Nacional de Productos Mdicos-ANMATWebsite:https:/www.argentina.gob.ar/anmat https:/helena.anmat.gob.ar/Boletin/http:/www.anmat.gov.ar/boletin_anmat/principal.aspNomenclature systems used for devices and tests:National l

166、ist for different types of healthcare facilities (hospitals,laboratories,etc)Lists available:YesWebsite-hospitals:https:/www.argentina.gob.ar/sssalud/hospitalesWebsite-laboratories:https:/helena.anmat.gob.ar/Boletin/http:/www.anmat.gov.ar/boletin_anmat/principal.aspNomenclature systems used for devi

167、ces and tests:National list for specific clinical interventions/emergencies:Lists available:YesWebsite:https:/www.argentina.gob.ar/salud/calidadatencionmedicaNational health technology assessment unitDesignated unit/department for health technology assessment(HTA):YesHTA unit/department includes the

168、 assessment of medical devices:YesUnit/department:Administracin Nacional de Medicamentos,Alimentos y Tecnologa Mdica(ANMAT)-Instituto Nacional de Productos Mdicos Website(s):https:/www.argentina.gob.ar/noticias/sobre-los-procesos-de-control-de-dispositivos-medicos http:/www.anmat.gov.ar/webanmat/nor

169、mativas_productosmedicos_cuerpo.asp http:/www.iecs.org.ar https:/www.argentina.gob.ar/salud/conetecContact:Manuel Donato Email:Committee includes a biomedical or clinical engineer:National regulatory authorityPresence of national authority responsible for regulating medical devices:YesName of regula

170、tory agency:Administracin Nacional de Medicamentos,Alimentos y Tecnologa Mdica(ANMAT)-Instituto Nacional de Productos MdicosWebsite(s):https:/www.argentina.gob.ar/anmat/regulados/productos-medicosContact:Lic.Andrea Bodnar Email:andrea.bodnaranmat.gob.arName(s)of other regulatory agency eg.for radiat

171、ion equipment etc.:Autoridad Regulatoria Nuclear(ARN)Other agencys website:https:/www.argentina.gob.ar/arnPopulation 000s(rank):a45,196(32)World Bank income group:bUpper-MiddleLife expectancy at birth(years):cYearsApproved devices lists comments(.Annex 1):Existe una base de datos que contiene a las

172、tecnologas sanitarias(denominados productos mdicos)registradas y disponibles en el sitio-ver tercera liga web-(accesible con colocar nombre gnerico de producto(por ej:apsito)o con su identificacin(N de PM).Health care facilities lists comments (.Annex 1):Ciruga,diagnstico por imgenes,laboratorio,ter

173、apia intensiva.Specific lists comments(.Annex 1):Actualmente existen lineamientos para la elaboracin de guas.Disponible en la segunda pgina web proporcionada.eHTA unit comments(.Annex 1):In 2018,by Ministerial Resolution of Health No.623,the National Commission for the Evaluation of Health Technolog

174、ies(CONETEC)was created within the scope of the Ministry of Health,dependent on its General Coordination Unit.National regulatory comments (.Annex 1):Under-five mortality(per 1000 live births):d8.56UHC-Service coverage index(1-100):h73Probability of dying aged 30-70 yrs from the 4 major NCDs(%):e15.

175、70%UHC-Population with household spending 10%(25%)of corresponding income(%):i()Human Development Index(inequality adjusted HDI):rank:f0.85(0.73):very highGlobal innovation index(rank):j28.3(80)ICT Development Index(rank):g6.8(51)High-technology exports(%of manufacture exports):k 5.20%15a UN:WPP 201

176、9,POP(data year:2020)b WB:FY23(data year:2021)c UN:WPP 2019,MORT(data year:1990-2020)d UN-IGME,SDG 3.2.1(data year:2020)e WHO:GHO,SDG 3.4.1(data year:2019)f UNDP:HDR 2019/20,HDI and IHDI(data year:2019)g ITU:IDI 2017(data year:2017)h WHO:GHO,SDG 3.8.1(data year:2019)i WHO:GHO,SDG 3.8.2,10%or 25%(dat

177、a year:latest 2010-18)j WIPO:GII(data year:2020)k UN-WB:HtE(data year:latest 2017-19)WHO:HTA&HBP 20/21 survey,HTA 2015,CSoMD21(data year:latest 2015 or 2021)WHO:GHO,ME;OECD,HE;CSoMD21(data year:latest 2013-21)WHO:GHO,RU;IAEA:DIRAC;CSoMD21(data year:latest 2013-21)WHO:GHO,HW;CSoMD21(data year:latest

178、2017-2021)n/a not applicable/not availableMedical device nomenclature systemOfficial nomenclature system for medical devices:Yes Type:Based on UMDNS Use:For regulatory purposesWebsite:Medical device incorporationProcurementPolicy or guideline:Yes Website:http:/www.anmat.gov.ar/webanmat/productos_med

179、icos/recomendaciones_compraprod.medicos.aspNational level procurement:Yes Website:http:/www.anmat.gov.ar/webanmat/productos_medicos/recomendaciones_compraprod.me dicos.aspDonationsPolicy or guideline:Yes Website:https:/www.argentina.gob.ar/anmat/regulados/productosmedicos/requisitos-para-el-ingreso-

180、al-pais-de-productos-donadosTechnical specificationsTechnical specifications to support procurement or donations:YesPublically available:YesWebsite:https:/www.argentina.gob.ar/anmat/regulados/productosmedicos/requisitos-para-el-ingreso-al-pais-de-productos-donadosMedical equipment management unitUni

181、t present:Professionally trained biomedical/clinical engineers:Unit/Department:Unidad Coordinadora de Evaluacin y Ejecucin de Tecnologas en Salud.Unit website:https:/www.argentina.gob.ar/anmatContact name:Dra.Anala del Carmen Amarilla Contact email:pngcmsal.gov.arWebsite with publically available te

182、chnical specifications:https:/www.argentina.gob.ar/anmatNumber of regional/state offices/units:0Inventories and medical equipment management software Type of inventories available:NoneWebsite:Use of management software:Software name:Medical devices workforceNumber of biomedical/clinical engineers pr

183、ofessionals in the country:1500ContactsNational officer(s):Name:Dra.Analia del Carmen AmarillaEmail:aamarillamsal.gov.arName:Email:General comments(.Annex 1):The MoH wants to push awareness/surveillance about health technology quality,technical specifications,etc.A1B2C3D4Nomenclature comments(.Annex

184、 1):The Administracin Nacional de Medicamentos Alimentos y Tecnologa Mdica(ANMAT),reported the use of the Universal Medical Device Nomenclature System(UMDNS)for regulatory purposes of the medical devices in this countryMedical device incorporation comments(.Annex 1):For procurement of medical device

185、s at national level we use the:“lista licitaciones”.Medical equipmentTotalDensity per 1,000,000 populationMagnetic Resonance Imaging:n/an/aComputerized Tomography Scanner:n/an/aPositron Emission Tomography Scanner:n/an/aGamma camera or nuclear medicine:n/an/aMammograph:,*n/an/aRadiotherapy:1793.96*D

186、ensity per 1,000,000 females aged from 50-69 old.Software comments(.Annex 1):WHO Country officer(s):Name:Dr.Eva Jan LlopisEmail:janellopispaho.orgName:Dra.Sonia QuezadaEmail:quezadaspaho.orgWHO Region of the AmericasArgentinaGlobal atlas of medical devices 2022 16ArmeniaCountry indicators -WHO count

187、ry informationNational policy on health technologyHealth technology(medical device)national policy:NoPolicy is part of the National Health Program/Plan:NoWebsite:Language(s):Ministry of health responsible for health technology policy implementation:National lists of medical devicesNational list of a

188、pproved priority/essential medical devices,(including IVDs),for procurement or reimbursement:Lists available:NoUnit:Website:Nomenclature systems used for devices and tests:National list for different types of healthcare facilities (hospitals,laboratories,etc)Lists available:YesWebsite-hospitals:Webs

189、ite-laboratories:Nomenclature systems used for devices and tests:National list for specific clinical interventions/emergencies:Lists available:NoWebsite:National health technology assessment unitDesignated unit/department for health technology assessment(HTA):YesHTA unit/department includes the asse

190、ssment of medical devices:YesUnit/department:Health Project Implementation Unit and Scientific Centre of Drug and Medical Technology Expertise.Website(s):https:/healthpiu.am/http:/www.pharm.am/index.php/en/aboutusContact:Mr.Armen Madantsyan Email:Committee includes a biomedical or clinical engineer:

191、National regulatory authorityPresence of national authority responsible for regulating medical devices:YesName of regulatory agency:Ministry of Health(MoH).Website(s):https:/www.moh.am/#3/27Contact:Mr.Armen Karapeyan Email:akarapetyanmoh.amName(s)of other regulatory agency eg.for radiation equipment

192、 etc.:Armenian Nuclear Regulatory Authority(ANRA).Other agencys website:http:/www.anra.am/index.aspx http:/www.pharm.am/index.php/en/Population 000s(rank):a2,963(134)World Bank income group:bUpper-MiddleLife expectancy at birth(years):cYearsApproved devices lists comments(.Annex 1):Health care facil

193、ities lists comments (.Annex 1):Specific lists comments(.Annex 1):eHTA unit comments(.Annex 1):Informing decisions of the cited institutions are not specifically HTA.Alternative email:infohealthpiu.arm.National regulatory comments (.Annex 1):“National Institute of Metrology”;National Institute of St

194、andards”;“ArmAtomInspection”;and“Scientific Center of Drug and Medical Technology Expertise”.Under-five mortality(per 1000 live births):d10.94UHC-Service coverage index(1-100):h69Probability of dying aged 30-70 yrs from the 4 major NCDs(%):e19.90%UHC-Population with household spending 10%(25%)of cor

195、responding income(%):i16.1%(4.9%)Human Development Index(inequality adjusted HDI):rank:f0.78(0.7):highGlobal innovation index(rank):j32.6(61)ICT Development Index(rank):g5.8(75)High-technology exports(%of manufacture exports):k 9.80%17a UN:WPP 2019,POP(data year:2020)b WB:FY23(data year:2021)c UN:WP

196、P 2019,MORT(data year:1990-2020)d UN-IGME,SDG 3.2.1(data year:2020)e WHO:GHO,SDG 3.4.1(data year:2019)f UNDP:HDR 2019/20,HDI and IHDI(data year:2019)g ITU:IDI 2017(data year:2017)h WHO:GHO,SDG 3.8.1(data year:2019)i WHO:GHO,SDG 3.8.2,10%or 25%(data year:latest 2010-18)j WIPO:GII(data year:2020)k UN-

197、WB:HtE(data year:latest 2017-19)WHO:HTA&HBP 20/21 survey,HTA 2015,CSoMD21(data year:latest 2015 or 2021)WHO:GHO,ME;OECD,HE;CSoMD21(data year:latest 2013-21)WHO:GHO,RU;IAEA:DIRAC;CSoMD21(data year:latest 2013-21)WHO:GHO,HW;CSoMD21(data year:latest 2017-2021)n/a not applicable/not availableMedical dev

198、ice nomenclature systemOfficial nomenclature system for medical devices:No Type:None Use:Not specifiedWebsite:Medical device incorporationProcurementPolicy or guideline:No Website:National level procurement:Yes Website:DonationsPolicy or guideline:No Website:Technical specificationsTechnical specifi

199、cations to support procurement or donations:YesPublically available:Website:Medical equipment management unitUnit present:Yes Professionally trained biomedical/clinical engineers:YesUnit/Department:Health Project Implementation Unit(HPIU).Unit website:http:/www.pharm.am/Contact name:Mr.Armen Madants

200、yan Contact email:HWebsite with publically available technical specifications:http:/www.pharm.am/attachments/article/183/Appendix_2_%20Notice%20to%20Applicants_eng.pdf http:/www.pharm.am/index.php/en/orders/5472-order-of-minister-of-health-of-the-republic-of-armenia-n02-n-of-january-21-2020-on-appro

201、val-of-the-requirements-of-labeling-and-packaging-for-medicinal-products-pharmaceutical-substances-herbal-raw-materials-investigational-medicinal-products-as-well-as-fNumber of regional/state offices/units:Inventories and medical equipment management software Type of inventories available:Website:ht

202、tp:/www.pharm.am/Use of management software:No Software name:Medical devices workforceNumber of biomedical/clinical engineers professionals in the country:ContactsNational officer(s):Name:Mr.Armen MadantsyanEmail:Name:Email:HGeneral comments(.Annex 1):A1B2C3D4Nomenclature comments(.Annex 1):Medical

203、device incorporation comments(.Annex 1):The technical specifications are developed by the Health Project Implementation Unit(HPIU)biomedical engineer in cooperation with international consultants.Medical equipmentTotalDensity per 1,000,000 populationMagnetic Resonance Imaging:72.35Computerized Tomog

204、raphy Scanner:93.02Positron Emission Tomography Scanner:00Gamma camera or nuclear medicine:41.34Mammograph:,*722.5Radiotherapy:51.69*Density per 1,000,000 females aged from 50-69 old.Software comments(.Annex 1):WHO Country officer(s):Name:Dr.Jihane F.TawilahEmail:tawilahjwho.intName:Email:WHO Europe

205、an RegionArmeniaGlobal atlas of medical devices 2022 18AustraliaCountry indicators -WHO country informationNational policy on health technologyHealth technology(medical device)national policy:NoPolicy is part of the National Health Program/Plan:NoWebsite:Language(s):Ministry of health responsible fo

206、r health technology policy implementation:National lists of medical devicesNational list of approved priority/essential medical devices,(including IVDs),for procurement or reimbursement:Lists available:Unit:Website:www.tga.gov.au/australian-register-therapeutic-goods Nomenclature systems used for de

207、vices and tests:National list for different types of healthcare facilities (hospitals,laboratories,etc)Lists available:Website-hospitals:Website-laboratories:Nomenclature systems used for devices and tests:GMDNNational list for specific clinical interventions/emergencies:Lists available:Website:Nati

208、onal health technology assessment unitDesignated unit/department for health technology assessment(HTA):YesHTA unit/department includes the assessment of medical devices:YesUnit/department:Pharmaceutical Benefits Advisory Committee/Medical Services Advisory Committee/Prostheses List Advisory Committe

209、e/Therapeutic Goods Administration.Committees including the Advisory Committee on Medical Devices(ACMD)Website(s):http:/www.msac.gov.au/internet/msac/publishing.nsf/Content/Factsheet-02 https:/www1.health.gov.au/internet/hta/publishing.nsf/Content/pbs-1 https:/www1.health.gov.au/internet/hta/publish

210、ing.nsf/Content/mbs-1 https:/www1.health.gov.au/internet/hta/publishing.nsf/Content/prostheses-1Contact:Email:htahealth.gov.au;devicestga.gov.auCommittee includes a biomedical or clinical engineer:YesNational regulatory authorityPresence of national authority responsible for regulating medical devic

211、es:YesName of regulatory agency:Australian Therapeutic Goods Administration(TGA).Website(s):http:/www.tga.gov.au/medical-devices-ivdsContact:Tracey Duffy Email:devicestga.gov.auName(s)of other regulatory agency eg.for radiation equipment etc.:Australian Radiation Protection and Nuclear Safety Agency

212、(ARPANSA).Other agencys website:https:/www.arpansa.gov.au/Population 000s(rank):a25,500(55)World Bank income group:bHighLife expectancy at birth(years):cYearsApproved devices lists comments(.Annex 1):Australian Register of Therapeutic Goods(ARTG)marketing approval and used to guide procurement in na

213、tional and state/territory processesProstheses List of implanted medical devices for private patients-Health care facilities lists comments (.Annex 1):Specific lists comments(.Annex 1):eHTA unit comments(.Annex 1):The Therapeutic Goods Administration(TGA),the Medical Services Advisory Committee(MSAC

214、),the Pharmaceutical Advisory Committee(PBAC),and the Prostheses List Advisory Committee(PLAC)perform Health Technology Assessment(HTA)processes to provide advice to the Australian Government Department of Health.National regulatory comments (.Annex 1):Under-five mortality(per 1000 live births):d3.7

215、UHC-Service coverage index(1-100):h87Probability of dying aged 30-70 yrs from the 4 major NCDs(%):e8.60%UHC-Population with household spending 10%(25%)of corresponding income(%):i3.7%(0.5%)Human Development Index(inequality adjusted HDI):rank:f0.94(0.87):very highGlobal innovation index(rank):j48.4(

216、23)ICT Development Index(rank):g8.2(14)High-technology exports(%of manufacture exports):k 21.50%19a UN:WPP 2019,POP(data year:2020)b WB:FY23(data year:2021)c UN:WPP 2019,MORT(data year:1990-2020)d UN-IGME,SDG 3.2.1(data year:2020)e WHO:GHO,SDG 3.4.1(data year:2019)f UNDP:HDR 2019/20,HDI and IHDI(dat

217、a year:2019)g ITU:IDI 2017(data year:2017)h WHO:GHO,SDG 3.8.1(data year:2019)i WHO:GHO,SDG 3.8.2,10%or 25%(data year:latest 2010-18)j WIPO:GII(data year:2020)k UN-WB:HtE(data year:latest 2017-19)WHO:HTA&HBP 20/21 survey,HTA 2015,CSoMD21(data year:latest 2015 or 2021)WHO:GHO,ME;OECD,HE;CSoMD21(data y

218、ear:latest 2013-21)WHO:GHO,RU;IAEA:DIRAC;CSoMD21(data year:latest 2013-21)WHO:GHO,HW;CSoMD21(data year:latest 2017-2021)n/a not applicable/not availableMedical device nomenclature systemOfficial nomenclature system for medical devices:Yes Type:Based on GMDN Use:Therapeutic goods regulation(market au

219、thorisation)and procurement purposes by Government and non-Government entities and hospitalsWebsite:www.tga.gov.au Medical device incorporationProcurementPolicy or guideline:National Medical Stockpile,National,State and Territory Governments Website:National level procurement:Website:DonationsPolicy

220、 or guideline:Website:Technical specificationsTechnical specifications to support procurement or donations:Publically available:Government procurement websites at national and state/territory levelsWebsite:Medical equipment management unitUnit present:Professionally trained biomedical/clinical engin

221、eers:Unit/Department:Unit website:Contact name:Contact email:Website with publically available technical specifications:Number of regional/state offices/units:Inventories and medical equipment management software Type of inventories available:Website:Use of management software:Software name:Medical

222、devices workforceNumber of biomedical/clinical engineers professionals in the country:320ContactsNational officer(s):Name:Mr.Chris BedfordEmail:chris.bedfordhealth.gov.auName:Email:General comments(.Annex 1):Australias health system policy and delivery is at both a national and state/territory level

223、.All medical devices must be included in the Australian Register of Therapeutic Goods.A1B2C3D4Nomenclature comments(.Annex 1):The use of GMDN is a legal mandatory requirement for devices supplied in Australia,including IVDs.Medical device incorporation comments(.Annex 1):Medical equipmentTotalDensit

224、y per 1,000,000 populationMagnetic Resonance Imaging:37514.71Computerized Tomography Scanner:178269.88Positron Emission Tomography Scanner:1024Gamma camera or nuclear medicine:48318.94Mammograph:,*589201.23Radiotherapy:2379.29*Density per 1,000,000 females aged from 50-69 old.Software comments(.Anne

225、x 1):The National Product Catalogue provides an inventory input to a number of hospital procurement and equipment managements systems.Also,various systems are used by public and private hospitalsWHO Country officer(s):Name:Email:Name:Email:WHO Western Pacific RegionAustraliaGlobal atlas of medical d

226、evices 2022 20AustriaCountry indicators -WHO country informationNational policy on health technologyHealth technology(medical device)national policy:YesPolicy is part of the National Health Program/Plan:YesWebsite:https:/www.sozialministerium.at/en.htmlLanguage(s):GermanMinistry of health responsibl

227、e for health technology policy implementation:National lists of medical devicesNational list of approved priority/essential medical devices,(including IVDs),for procurement or reimbursement:Lists available:YesUnit:Hauptverband der sterreichischen Sozialversicherungstrger.Website:Nomenclature systems

228、 used for devices and tests:National list for different types of healthcare facilities (hospitals,laboratories,etc)Lists available:YesWebsite-hospitals:https:/www.sozialministerium.at/public.htmlWebsite-laboratories:https:/www.sozialministerium.at/public.htmlNomenclature systems used for devices and

229、 tests:National list for specific clinical interventions/emergencies:Lists available:YesWebsite:https:/www.sozialministerium.at/public.htmlNational health technology assessment unitDesignated unit/department for health technology assessment(HTA):YesHTA unit/department includes the assessment of medi

230、cal devices:YesUnit/department:GOEG/BIQGWebsite(s):http:/www.goeg.at https:/aihta.at http:/www.sozialversicherung.atContact:Ms.Eva Kernstock Email:eva.kernstockgoeg.atCommittee includes a biomedical or clinical engineer:National regulatory authorityPresence of national authority responsible for regu

231、lating medical devices:YesName of regulatory agency:Austrian Medicines and Medical Devices Agency(BASG).Website(s):http:/www.basg.gv.at/en/medical-devices/Contact:Dr.Martin Renhardt Email:martin.renhardtbmg.gv.atName(s)of other regulatory agency eg.for radiation equipment etc.:Austrian Federal Offic

232、e for Safety in Health Care/Bundesamt fr Sicherheit im Gesundheitswesen(BASG);International Atomic Energy Agency(IAEA).Other agencys website:https:/www.basg.gv.at https:/www-pub.iaea.org/MTCD/Publications/PDF/CSPS-7-P.pdfPopulation 000s(rank):a9,006(96)World Bank income group:bHighLife expectancy at

233、 birth(years):cYearsApproved devices lists comments(.Annex 1):Health care facilities lists comments (.Annex 1):Specific lists comments(.Annex 1):sterreichischer Strukturplan Gesundheit(up mentioned link)and various guidelines of the medical societies,internal guidelines of the hospitals,etc.Also,the

234、re is the Austrian Influenza Pandemic Plan.eHTA unit comments(.Annex 1):Only for the hospital benefit catalogue there is a national HTA process in place,but not for drugs.It is expected that it will be a process in place in the next 1-2 years.National regulatory comments (.Annex 1):Under-five mortal

235、ity(per 1000 live births):d3.62UHC-Service coverage index(1-100):h82Probability of dying aged 30-70 yrs from the 4 major NCDs(%):e10.40%UHC-Population with household spending 10%(25%)of corresponding income(%):i()Human Development Index(inequality adjusted HDI):rank:f0.92(0.86):very highGlobal innov

236、ation index(rank):j50.1(19)ICT Development Index(rank):g8(21)High-technology exports(%of manufacture exports):k 11.50%21a UN:WPP 2019,POP(data year:2020)b WB:FY23(data year:2021)c UN:WPP 2019,MORT(data year:1990-2020)d UN-IGME,SDG 3.2.1(data year:2020)e WHO:GHO,SDG 3.4.1(data year:2019)f UNDP:HDR 20

237、19/20,HDI and IHDI(data year:2019)g ITU:IDI 2017(data year:2017)h WHO:GHO,SDG 3.8.1(data year:2019)i WHO:GHO,SDG 3.8.2,10%or 25%(data year:latest 2010-18)j WIPO:GII(data year:2020)k UN-WB:HtE(data year:latest 2017-19)WHO:HTA&HBP 20/21 survey,HTA 2015,CSoMD21(data year:latest 2015 or 2021)WHO:GHO,ME;

238、OECD,HE;CSoMD21(data year:latest 2013-21)WHO:GHO,RU;IAEA:DIRAC;CSoMD21(data year:latest 2013-21)WHO:GHO,HW;CSoMD21(data year:latest 2017-2021)n/a not applicable/not availableMedical device nomenclature systemOfficial nomenclature system for medical devices:Yes Type:Based on EMDN Use:For regulatory p

239、urposesWebsite:https:/goeg.at/MedizinprodukteregisterMedical device incorporationProcurementPolicy or guideline:Yes Website:http:/www.hauptverband.at/National level procurement:No Website:DonationsPolicy or guideline:Yes Website:Technical specificationsTechnical specifications to support procurement

240、 or donations:YesPublically available:NoWebsite:Medical equipment management unitUnit present:Yes Professionally trained biomedical/clinical engineers:YesUnit/Department:Abteilung Medizinprodukte within MoH(BMSPGK).Unit website:http:/www.bmg.gv.atContact name:Dr.Martin Renhardt Contact email:martin.

241、renhardtbmg.gv.atWebsite with publically available technical specifications:https:/www.sozialministerium.at/Themen/Gesundheit/Medizin-und-Gesundheitsberufe/Medizin/Medizinprodukte/Erlaesse-und-Richtlinien-im-Bereich-Medizinprodukte.htmlNumber of regional/state offices/units:9Inventories and medical

242、equipment management software Type of inventories available:National inventory only for high cost technologies(such as MRI,CT or PET scanners)Website:https:/www.sozialministerium.at/Use of management software:Yes Software name:Various:MTECS,Visual FM,SAP,etc.Medical devices workforceNumber of biomed

243、ical/clinical engineers professionals in the country:800ContactsNational officer(s):Name:Dr.Martin RenhardtEmail:martin.renhardtbmg.gv.atName:Email:General comments(.Annex 1):A1B2C3D4Nomenclature comments(.Annex 1):As per regulation 2017/45 on medical devices and Regulation(EU)2017/746,the EU Member

244、 States Competent Authorities of MD representatives(of both the national MoH and the national agencies)of the MDCG,have opted for the publicly available,accessible and transparent nomenclature named European Medical Device Nomenclature(EMDN)Medical device incorporation comments(.Annex 1):The procure

245、ment is done with internal guidelines of the Hauptverband,insurance funds,hospitals,Bundesbeschaffungs GmbH,etc.Medical equipmentTotalDensity per 1,000,000 populationMagnetic Resonance Imaging:20823.1Computerized Tomography Scanner:25528.31Positron Emission Tomography Scanner:242.66Gamma camera or n

246、uclear medicine:9310.33Mammograph:,*190153.52Radiotherapy:768.44*Density per 1,000,000 females aged from 50-69 old.Software comments(.Annex 1):There are various software for the maintenance and inspection of medical devices in the hospital.Additionally,there is the implementation of a National Plan

247、for high-cost technologies called:“Grogerteplan”.WHO Country officer(s):Name:Email:Name:Email:WHO European RegionAustriaGlobal atlas of medical devices 2022 22AzerbaijanCountry indicators -WHO country informationNational policy on health technologyHealth technology(medical device)national policy:NoP

248、olicy is part of the National Health Program/Plan:NoWebsite:Language(s):Ministry of health responsible for health technology policy implementation:Health Organization Department.National lists of medical devicesNational list of approved priority/essential medical devices,(including IVDs),for procure

249、ment or reimbursement:Lists available:Yes,but it is only a recommendationUnit:Medical Technical Department of the Innovation and Supply Centre.Website:Nomenclature systems used for devices and tests:National list for different types of healthcare facilities (hospitals,laboratories,etc)Lists availabl

250、e:Website-hospitals:Website-laboratories:Nomenclature systems used for devices and tests:National list for specific clinical interventions/emergencies:Lists available:NoWebsite:National health technology assessment unitDesignated unit/department for health technology assessment(HTA):YesHTA unit/depa

251、rtment includes the assessment of medical devices:YesUnit/department:Website(s):https:/www.isim.az/en/mainContact:Mr.Kerimov Ramiz Talat Email:Committee includes a biomedical or clinical engineer:National regulatory authorityPresence of national authority responsible for regulating medical devices:N

252、oName of regulatory agency:Analytical Expertise Center(MMA).Website(s):http:/www.pharma.az/Contact:Email:Name(s)of other regulatory agency eg.for radiation equipment etc.:State Agency for Normal and Radiological Activity Regulation(Ministry of Emergency Situations of the Republic of Azerbaijan).Othe

253、r agencys website:https:/www.nuve.fhn.gov.az/organizations.php?aze-7Population 000s(rank):a10,139(89)World Bank income group:bUpper-MiddleLife expectancy at birth(years):cYearsApproved devices lists comments(.Annex 1):Health care facilities lists comments (.Annex 1):Specific lists comments(.Annex 1)

254、:eHTA unit comments(.Annex 1):The HTA activities in pharmaceutics are not specifically for medical devices.National regulatory comments (.Annex 1):Under-five mortality(per 1000 live births):d19.39UHC-Service coverage index(1-100):h65Probability of dying aged 30-70 yrs from the 4 major NCDs(%):e27.20

255、%UHC-Population with household spending 10%(25%)of corresponding income(%):i()Human Development Index(inequality adjusted HDI):rank:f0.76(0.68):highGlobal innovation index(rank):j27.2(82)ICT Development Index(rank):g6.2(65)High-technology exports(%of manufacture exports):k 5.00%23a UN:WPP 2019,POP(d

256、ata year:2020)b WB:FY23(data year:2021)c UN:WPP 2019,MORT(data year:1990-2020)d UN-IGME,SDG 3.2.1(data year:2020)e WHO:GHO,SDG 3.4.1(data year:2019)f UNDP:HDR 2019/20,HDI and IHDI(data year:2019)g ITU:IDI 2017(data year:2017)h WHO:GHO,SDG 3.8.1(data year:2019)i WHO:GHO,SDG 3.8.2,10%or 25%(data year:

257、latest 2010-18)j WIPO:GII(data year:2020)k UN-WB:HtE(data year:latest 2017-19)WHO:HTA&HBP 20/21 survey,HTA 2015,CSoMD21(data year:latest 2015 or 2021)WHO:GHO,ME;OECD,HE;CSoMD21(data year:latest 2013-21)WHO:GHO,RU;IAEA:DIRAC;CSoMD21(data year:latest 2013-21)WHO:GHO,HW;CSoMD21(data year:latest 2017-20

258、21)n/a not applicable/not availableMedical device nomenclature systemOfficial nomenclature system for medical devices:No Type:None Use:Not specifiedWebsite:Medical device incorporationProcurementPolicy or guideline:No Website:National level procurement:Yes Website:DonationsPolicy or guideline:Yes We

259、bsite:https:/apps.who.int/iris/bitstream/handle/10665/44568/9789241501408_eng.pdf?sequence=1Technical specificationsTechnical specifications to support procurement or donations:NoPublically available:Website:Medical equipment management unitUnit present:Professionally trained biomedical/clinical eng

260、ineers:NoUnit/Department:Innovation and Supply Centre.Unit website:Contact name:Mr.Ramiz Kerimov Contact email:Website with publically available technical specifications:Number of regional/state offices/units:0Inventories and medical equipment management software Type of inventories available:Nation

261、al inventory for medical equipmentWebsite:Use of management software:No Software name:Medical devices workforceNumber of biomedical/clinical engineers professionals in the country:ContactsNational officer(s):Name:Mr.Kerimov Ramiz TalatEmail:Name:Mr.Ramiz KerimovEmail:General comments(.Annex 1):A1B2C

262、3D4Nomenclature comments(.Annex 1):Medical device incorporation comments(.Annex 1):The Procurement guidelines are under development.For donations guidelines the WHO are the ones used.The corresponding technical specifications are under the responsibility of the Innovation and Supply Centre.Medical e

263、quipmentTotalDensity per 1,000,000 populationMagnetic Resonance Imaging:141.38Computerized Tomography Scanner:515.03Positron Emission Tomography Scanner:20.2Gamma camera or nuclear medicine:n/an/aMammograph:,*2522.5Radiotherapy:121.18*Density per 1,000,000 females aged from 50-69 old.Software commen

264、ts(.Annex 1):WHO Country officer(s):Name:Dr.Fatos Hande HarmanciEmail:harmancihwho.intName:Email:WHO European RegionAzerbaijanGlobal atlas of medical devices 2022 24BahamasCountry indicators -WHO country informationNational policy on health technologyHealth technology(medical device)national policy:

265、NoPolicy is part of the National Health Program/Plan:NoWebsite:Language(s):Ministry of health responsible for health technology policy implementation:National lists of medical devicesNational list of approved priority/essential medical devices,(including IVDs),for procurement or reimbursement:Lists

266、available:NoUnit:Website:Nomenclature systems used for devices and tests:National list for different types of healthcare facilities (hospitals,laboratories,etc)Lists available:NoWebsite-hospitals:Website-laboratories:Nomenclature systems used for devices and tests:National list for specific clinical

267、 interventions/emergencies:Lists available:NoWebsite:National health technology assessment unitDesignated unit/department for health technology assessment(HTA):NoHTA unit/department includes the assessment of medical devices:NoUnit/department:Website(s):Contact:Email:Committee includes a biomedical

268、or clinical engineer:National regulatory authorityPresence of national authority responsible for regulating medical devices:NoName of regulatory agency:Ministry of Health(MoH).Website(s):https:/www.bahamas.gov.bs Contact:Email:Name(s)of other regulatory agency eg.for radiation equipment etc.:Other a

269、gencys website:Population 000s(rank):a393(170)World Bank income group:bHighLife expectancy at birth(years):cYearsApproved devices lists comments(.Annex 1):Health care facilities lists comments (.Annex 1):Specific lists comments(.Annex 1):There are no lists recommending health technology for any of t

270、he above.eHTA unit comments(.Annex 1):National regulatory comments (.Annex 1):Under-five mortality(per 1000 live births):d12.26UHC-Service coverage index(1-100):h70Probability of dying aged 30-70 yrs from the 4 major NCDs(%):e19.90%UHC-Population with household spending 10%(25%)of corresponding inco

271、me(%):i2.7%(0.2%)Human Development Index(inequality adjusted HDI):rank:f0.81():very highGlobal innovation index(rank):j()ICT Development Index(rank):g6.5(57)High-technology exports(%of manufacture exports):k 2.00%25a UN:WPP 2019,POP(data year:2020)b WB:FY23(data year:2021)c UN:WPP 2019,MORT(data yea

272、r:1990-2020)d UN-IGME,SDG 3.2.1(data year:2020)e WHO:GHO,SDG 3.4.1(data year:2019)f UNDP:HDR 2019/20,HDI and IHDI(data year:2019)g ITU:IDI 2017(data year:2017)h WHO:GHO,SDG 3.8.1(data year:2019)i WHO:GHO,SDG 3.8.2,10%or 25%(data year:latest 2010-18)j WIPO:GII(data year:2020)k UN-WB:HtE(data year:lat

273、est 2017-19)WHO:HTA&HBP 20/21 survey,HTA 2015,CSoMD21(data year:latest 2015 or 2021)WHO:GHO,ME;OECD,HE;CSoMD21(data year:latest 2013-21)WHO:GHO,RU;IAEA:DIRAC;CSoMD21(data year:latest 2013-21)WHO:GHO,HW;CSoMD21(data year:latest 2017-2021)n/a not applicable/not availableMedical device nomenclature sys

274、temOfficial nomenclature system for medical devices:No Type:None Use:Not specifiedWebsite:Medical device incorporationProcurementPolicy or guideline:No Website:National level procurement:Yes Website:http:/www.phabahamas.org/DonationsPolicy or guideline:No Website:Technical specificationsTechnical sp

275、ecifications to support procurement or donations:NoPublically available:Website:Medical equipment management unitUnit present:Yes Professionally trained biomedical/clinical engineers:YesUnit/Department:Supplies Management Agency.Unit website:Contact name:Mr.Audley Bain Contact email:abain1pmh.phabah

276、amas.orgWebsite with publically available technical specifications:Number of regional/state offices/units:0Inventories and medical equipment management software Type of inventories available:NoneWebsite:Use of management software:No Software name:Medical devices workforceNumber of biomedical/clinica

277、l engineers professionals in the country:ContactsNational officer(s):Name:Dr.Anthone WardEmail:awardphabahamas.orgName:Email:General comments(.Annex 1):A1B2C3D4Nomenclature comments(.Annex 1):Medical device incorporation comments(.Annex 1):The Public Hospitals Authority,the corporate entity of the M

278、inistry of Health,is responsible for managing the three Public Hospitals within the Bahamas.It uses the services of the ECRI Institute to assist in the procurement of medical devices.Medical equipmentTotalDensity per 1,000,000 populationMagnetic Resonance Imaging:12.54Computerized Tomography Scanner

279、:512.72Positron Emission Tomography Scanner:00Gamma camera or nuclear medicine:00Mammograph:,*495.1Radiotherapy:25.09*Density per 1,000,000 females aged from 50-69 old.Software comments(.Annex 1):WHO Country officer(s):Name:Dr.Eldonna BoissonEmail:boissoelpaho.orgName:Dr.Gabriel VivasEmail:vivasfgab

280、paho.orgWHO Region of the AmericasBahamasGlobal atlas of medical devices 2022 26BahrainCountry indicators -WHO country informationNational policy on health technologyHealth technology(medical device)national policy:Policy is part of the National Health Program/Plan:Website:Language(s):Ministry of he

281、alth responsible for health technology policy implementation:National lists of medical devicesNational list of approved priority/essential medical devices,(including IVDs),for procurement or reimbursement:Lists available:Unit:Website:Nomenclature systems used for devices and tests:National list for

282、different types of healthcare facilities (hospitals,laboratories,etc)Lists available:Website-hospitals:Website-laboratories:Nomenclature systems used for devices and tests:National list for specific clinical interventions/emergencies:Lists available:Website:National health technology assessment unit

283、Designated unit/department for health technology assessment(HTA):NoHTA unit/department includes the assessment of medical devices:NoUnit/department:Website(s):Contact:Email:Committee includes a biomedical or clinical engineer:National regulatory authorityPresence of national authority responsible fo

284、r regulating medical devices:Name of regulatory agency:National Health Regulatory Authority,Kingdom of Bahrain.Website(s):https:/www.nhra.bh/https:/www.moh.gov.bh/?lang=enContact:Email:Name(s)of other regulatory agency eg.for radiation equipment etc.:Ministry of Health;Supreme Council for Environmen

285、t.Other agencys website:https:/www.moh.gov.bh/?lang=en;ECD:https:/www.sce.gov.bh/en/CommunicationGuide?cms=iQRpheuphYtJ6pyXUGiNqgEU69X91IJiPopulation 000s(rank):a1,702(148)World Bank income group:bHighLife expectancy at birth(years):cYearsApproved devices lists comments(.Annex 1):Health care facilit

286、ies lists comments (.Annex 1):Specific lists comments(.Annex 1):eHTA unit comments(.Annex 1):There are identified HTA activities but not a national unit.National regulatory comments (.Annex 1):Under-five mortality(per 1000 live births):d6.76UHC-Service coverage index(1-100):h71Probability of dying a

287、ged 30-70 yrs from the 4 major NCDs(%):e16.10%UHC-Population with household spending 10%(25%)of corresponding income(%):i()Human Development Index(inequality adjusted HDI):rank:f0.85():very highGlobal innovation index(rank):j28.4(79)ICT Development Index(rank):g7.6(31)High-technology exports(%of man

288、ufacture exports):k 0.40%27a UN:WPP 2019,POP(data year:2020)b WB:FY23(data year:2021)c UN:WPP 2019,MORT(data year:1990-2020)d UN-IGME,SDG 3.2.1(data year:2020)e WHO:GHO,SDG 3.4.1(data year:2019)f UNDP:HDR 2019/20,HDI and IHDI(data year:2019)g ITU:IDI 2017(data year:2017)h WHO:GHO,SDG 3.8.1(data year

289、:2019)i WHO:GHO,SDG 3.8.2,10%or 25%(data year:latest 2010-18)j WIPO:GII(data year:2020)k UN-WB:HtE(data year:latest 2017-19)WHO:HTA&HBP 20/21 survey,HTA 2015,CSoMD21(data year:latest 2015 or 2021)WHO:GHO,ME;OECD,HE;CSoMD21(data year:latest 2013-21)WHO:GHO,RU;IAEA:DIRAC;CSoMD21(data year:latest 2013-

290、21)WHO:GHO,HW;CSoMD21(data year:latest 2017-2021)n/a not applicable/not availableMedical device nomenclature systemOfficial nomenclature system for medical devices:Yes Type:More than one system Use:For regulatory and procurement purposesWebsite:https:/www.nhra.bh/Departments/MDR/https:/www.nhra.bh/M

291、edical device incorporationProcurementPolicy or guideline:Website:National level procurement:Website:DonationsPolicy or guideline:Website:Technical specificationsTechnical specifications to support procurement or donations:Publically available:Website:Medical equipment management unitUnit present:Pr

292、ofessionally trained biomedical/clinical engineers:Unit/Department:Unit website:Contact name:Contact email:Website with publically available technical specifications:Number of regional/state offices/units:Inventories and medical equipment management software Type of inventories available:Website:Use

293、 of management software:Software name:Medical devices workforceNumber of biomedical/clinical engineers professionals in the country:10%(25%)of corresponding income(%):i24.7%(9.5%)Human Development Index(inequality adjusted HDI):rank:f0.63(0.48):mediumGlobal innovation index(rank):j20.4(116)ICT Devel

294、opment Index(rank):g2.5(147)High-technology exports(%of manufacture exports):k 29a UN:WPP 2019,POP(data year:2020)b WB:FY23(data year:2021)c UN:WPP 2019,MORT(data year:1990-2020)d UN-IGME,SDG 3.2.1(data year:2020)e WHO:GHO,SDG 3.4.1(data year:2019)f UNDP:HDR 2019/20,HDI and IHDI(data year:2019)g ITU

295、:IDI 2017(data year:2017)h WHO:GHO,SDG 3.8.1(data year:2019)i WHO:GHO,SDG 3.8.2,10%or 25%(data year:latest 2010-18)j WIPO:GII(data year:2020)k UN-WB:HtE(data year:latest 2017-19)WHO:HTA&HBP 20/21 survey,HTA 2015,CSoMD21(data year:latest 2015 or 2021)WHO:GHO,ME;OECD,HE;CSoMD21(data year:latest 2013-2

296、1)WHO:GHO,RU;IAEA:DIRAC;CSoMD21(data year:latest 2013-21)WHO:GHO,HW;CSoMD21(data year:latest 2017-2021)n/a not applicable/not availableMedical device nomenclature systemOfficial nomenclature system for medical devices:No Type:None Use:Not specifiedWebsite:Medical device incorporationProcurementPolic

297、y or guideline:Yes Website:http:/www.cptu.gov.bd/default.aspx https:/cptu.gov.bd/index.htmlNational level procurement:Yes Website:http:/www.cptu.gov.bd/default.aspx https:/cptu.gov.bd/procurement-policy-and-procedure-documents.htmlDonationsPolicy or guideline:Yes Website:Technical specificationsTech

298、nical specifications to support procurement or donations:YesPublically available:NoWebsite:https:/cptu.gov.bd/index.htmlMedical equipment management unitUnit present:Yes Professionally trained biomedical/clinical engineers:YesUnit/Department:Unit website:Contact name:Contact email:Website with publi

299、cally available technical specifications:Number of regional/state offices/units:Inventories and medical equipment management software Type of inventories available:Website:Use of management software:Software name:Medical devices workforceNumber of biomedical/clinical engineers professionals in the c

300、ountry:10%(25%)of corresponding income(%):i16.4%(3.8%)Human Development Index(inequality adjusted HDI):rank:f0.81(0.68):very highGlobal innovation index(rank):j()ICT Development Index(rank):g7.3(34)High-technology exports(%of manufacture exports):k 13.70%31a UN:WPP 2019,POP(data year:2020)b WB:FY23(

301、data year:2021)c UN:WPP 2019,MORT(data year:1990-2020)d UN-IGME,SDG 3.2.1(data year:2020)e WHO:GHO,SDG 3.4.1(data year:2019)f UNDP:HDR 2019/20,HDI and IHDI(data year:2019)g ITU:IDI 2017(data year:2017)h WHO:GHO,SDG 3.8.1(data year:2019)i WHO:GHO,SDG 3.8.2,10%or 25%(data year:latest 2010-18)j WIPO:GI

302、I(data year:2020)k UN-WB:HtE(data year:latest 2017-19)WHO:HTA&HBP 20/21 survey,HTA 2015,CSoMD21(data year:latest 2015 or 2021)WHO:GHO,ME;OECD,HE;CSoMD21(data year:latest 2013-21)WHO:GHO,RU;IAEA:DIRAC;CSoMD21(data year:latest 2013-21)WHO:GHO,HW;CSoMD21(data year:latest 2017-2021)n/a not applicable/no

303、t availableMedical device nomenclature systemOfficial nomenclature system for medical devices:No Type:None Use:Not specifiedWebsite:Medical device incorporationProcurementPolicy or guideline:No Website:National level procurement:Yes Website:DonationsPolicy or guideline:No Website:Technical specifica

304、tionsTechnical specifications to support procurement or donations:YesPublically available:NoWebsite:Medical equipment management unitUnit present:Yes Professionally trained biomedical/clinical engineers:YesUnit/Department:Unit website:Contact name:Contact email:Website with publically available tech

305、nical specifications:Number of regional/state offices/units:Inventories and medical equipment management software Type of inventories available:Website:Use of management software:Yes Software name:Equipment Management Software.Medical devices workforceNumber of biomedical/clinical engineers professi

306、onals in the country:10%(25%)of corresponding income(%):i9.2%(0.7%)Human Development Index(inequality adjusted HDI):rank:f0.82(0.77):very highGlobal innovation index(rank):j31.3(64)ICT Development Index(rank):g7.6(32)High-technology exports(%of manufacture exports):k 4.30%33a UN:WPP 2019,POP(data ye

307、ar:2020)b WB:FY23(data year:2021)c UN:WPP 2019,MORT(data year:1990-2020)d UN-IGME,SDG 3.2.1(data year:2020)e WHO:GHO,SDG 3.4.1(data year:2019)f UNDP:HDR 2019/20,HDI and IHDI(data year:2019)g ITU:IDI 2017(data year:2017)h WHO:GHO,SDG 3.8.1(data year:2019)i WHO:GHO,SDG 3.8.2,10%or 25%(data year:latest

308、 2010-18)j WIPO:GII(data year:2020)k UN-WB:HtE(data year:latest 2017-19)WHO:HTA&HBP 20/21 survey,HTA 2015,CSoMD21(data year:latest 2015 or 2021)WHO:GHO,ME;OECD,HE;CSoMD21(data year:latest 2013-21)WHO:GHO,RU;IAEA:DIRAC;CSoMD21(data year:latest 2013-21)WHO:GHO,HW;CSoMD21(data year:latest 2017-2021)n/a

309、 not applicable/not availableMedical device nomenclature systemOfficial nomenclature system for medical devices:Yes Type:Nationally developed Use:Not specifiedWebsite:https:/www.rceth.by/Documents/3mz3prN132420141216.pdfMedical device incorporationProcurementPolicy or guideline:Yes Website:http:/min

310、zdrav.gov.by/en/ministerstvo/tsentralizovannye-zakupki.phpNational level procurement:Yes Website:http:/minzdrav.gov.by/en/dlya-spetsialistov/meditsinskie-izdeliya/zakupki-meditsinskikh-izdeliy.php https:/www.rceth.by/ru/Documents/Med http:/www.belmt.by/DonationsPolicy or guideline:Yes Website:http:/

311、minzdrav.gov.by/upload/dadvfiles/250.pdfTechnical specificationsTechnical specifications to support procurement or donations:YesPublically available:Website:Medical equipment management unitUnit present:Yes Professionally trained biomedical/clinical engineers:YesUnit/Department:Department for the sa

312、le,installation and repair of medical equipment(Belmedtekhnika).Unit website:http:/minzdrav.gov.by/en/dlya-spetsialistov/meditsinskie-izdeliya/index.php http:/www.belmt.by/Contact name:Mr.V.A.Hodzhaev Contact email:infobelmt.byWebsite with publically available technical specifications:Number of regi

313、onal/state offices/units:7Inventories and medical equipment management software Type of inventories available:National inventory for medical equipmentWebsite:http:/minzdrav.gov.by/ru/sobytiya/cozdanie-kataloga-izdeliy-meditsinskogo-naznacheniya/http:/www.rceth.byUse of management software:Yes Softwa

314、re name:Medical devices workforceNumber of biomedical/clinical engineers professionals in the country:ContactsNational officer(s):Name:Mr.V.A.HodzhaevEmail:infobelmt.byGeneral comments(.Annex 1):A1B2C3D4Nomenclature comments(.Annex 1):State register of medical equipment and medical supplies of Belar

315、us.Medical device incorporation comments(.Annex 1):Public procurement of medical devices and their specifications for each procurement procedure can be found in our website.Medical equipmentTotalDensity per 1,000,000 populationMagnetic Resonance Imaging:242.57Computerized Tomography Scanner:586.2Pos

316、itron Emission Tomography Scanner:00Gamma camera or nuclear medicine:242.57Mammograph:,*2317.48Radiotherapy:616.46*Density per 1,000,000 females aged from 50-69 old.Software comments(.Annex 1):Go to website(first link)and find the document titled“mfindr”.WHO Country officer(s):Name:Dr.Viatcheslav Gr

317、ankov AIEmail:eurowhoblrwho.intWHO European RegionBelarusGlobal atlas of medical devices 2022 34BelgiumCountry indicators -WHO country informationNational policy on health technologyHealth technology(medical device)national policy:YesPolicy is part of the National Health Program/Plan:YesWebsite:http

318、s:/www.afmps.be/fr/humain/produits_de_sante/dispositifs_medicaux/generalites/legislationLanguage(s):Franais et NerlandaisMinistry of health responsible for health technology policy implementation:Agence Fdrale des Mdicaments et des Produits de Sant pour les dispositifs mdicaux et les dispositifs mdi

319、caux implantables actifs et lInstitut Scientifique de Sant Publique-Section de Biologie clinique-pour les dispositifs mdicaux de diagnostic in vitro.National lists of medical devicesNational list of approved priority/essential medical devices,(including IVDs),for procurement or reimbursement:Lists a

320、vailable:Yes,but it is only a recommendationUnit:Institut National dAssurance Maladie Invalidit(INAMI).Website:https:/www.riziv.fgov.be/fr/Pages/default.aspxNomenclature systems used for devices and tests:National list for different types of healthcare facilities (hospitals,laboratories,etc)Lists av

321、ailable:Website-hospitals:Website-laboratories:http:/www.ejustice.just.fgov.be/cgi_loi/loi_a.pl?language=fr&caller=list&cn=2001111446&la=f&fromtab=loi&sql=dt=%27arrete%20royal%27&tri=dd+as+rank&rech=1&numero=1Nomenclature systems used for devices and tests:National list for specific clinical interve

322、ntions/emergencies:Lists available:YesWebsite:National health technology assessment unitDesignated unit/department for health technology assessment(HTA):YesHTA unit/department includes the assessment of medical devices:YesUnit/department:Health Care Knowledge Center(KCE).Website(s):https:/kce.fgov.b

323、e/en/health-technology-assessment https:/kce.fgov.be/en/towards-a-guided-and-phased-introduction-of-high-risk-medical-devices-in-belgium https:/www.wiv-isp.be/en http:/www.inami.fgov.be/Contact:Email:infokce.fgov.beCommittee includes a biomedical or clinical engineer:National regulatory authorityPre

324、sence of national authority responsible for regulating medical devices:YesName of regulatory agency:Agence Fdrale des Mdicaments et des Produits de Sant(AFMPS).Website(s):https:/www.afmps.be/frContact:Ms.Frdrique Meulders Email:frederique.meuldersafmps.beName(s)of other regulatory agency eg.for radi

325、ation equipment etc.:Competent Authority for in vitro diagnostic medical devices.Scientific Institute of Public Health-Dept.Clinical Biology Anne Van Nerom-and Agence Fdrale de Contrle Nuclaire.Other agencys website:https:/afcn.fgov.be/frPopulation 000s(rank):a11,590(80)World Bank income group:bHigh

326、Life expectancy at birth(years):cYearsApproved devices lists comments(.Annex 1):Ces listes existent indirectement par le remboursement de certains dispositifs mdicaux et/ou le remboursement de certains tests cliniques effectus.Les dispositifs mdicaux implantables et invasifs long terme doivent se tr

327、ouver Health care facilities lists comments (.Annex 1):Specific lists comments(.Annex 1):Ces listes existent indirectement par le remboursement de certains dispositifs mdicaux et/ou le remboursement de certains tests cliniques effectus.eHTA unit comments(.Annex 1):The assestment includes pre-market

328、clinical evaluation of innovative high-risk medical devices.National regulatory comments (.Annex 1):Agence Fdrale de Contrle Nuclaire en ce qui concerne les dispositifs mdicaux repris sous le point 3 de lannexe XIII de lArrt royal du 18/03/1999,qui veille au contrle et lapplication du Rglement Gnral

329、 de la Protection de la population,Under-five mortality(per 1000 live births):d4.23UHC-Service coverage index(1-100):h85Probability of dying aged 30-70 yrs from the 4 major NCDs(%):e10.60%UHC-Population with household spending 10%(25%)of corresponding income(%):i11.5%(1.4%)Human Development Index(in

330、equality adjusted HDI):rank:f0.93(0.86):very highGlobal innovation index(rank):j49.1(22)ICT Development Index(rank):g7.8(25)High-technology exports(%of manufacture exports):k 12.00%35a UN:WPP 2019,POP(data year:2020)b WB:FY23(data year:2021)c UN:WPP 2019,MORT(data year:1990-2020)d UN-IGME,SDG 3.2.1(

331、data year:2020)e WHO:GHO,SDG 3.4.1(data year:2019)f UNDP:HDR 2019/20,HDI and IHDI(data year:2019)g ITU:IDI 2017(data year:2017)h WHO:GHO,SDG 3.8.1(data year:2019)i WHO:GHO,SDG 3.8.2,10%or 25%(data year:latest 2010-18)j WIPO:GII(data year:2020)k UN-WB:HtE(data year:latest 2017-19)WHO:HTA&HBP 20/21 su

332、rvey,HTA 2015,CSoMD21(data year:latest 2015 or 2021)WHO:GHO,ME;OECD,HE;CSoMD21(data year:latest 2013-21)WHO:GHO,RU;IAEA:DIRAC;CSoMD21(data year:latest 2013-21)WHO:GHO,HW;CSoMD21(data year:latest 2017-2021)n/a not applicable/not availableMedical device nomenclature systemOfficial nomenclature system

333、for medical devices:Yes Type:Based on EMDN Use:For regulatory purposesWebsite:https:/kce.fgov.be/en https:/www.famhp.be/enMedical device incorporationProcurementPolicy or guideline:Yes Website:https:/www.afmps.be/fr https:/www.sciensano.be/enNational level procurement:No Website:https:/www.afmps.be/fr https:/www.sciensano.be/enDonationsPolicy or guideline:No Website:Technical specificationsTechnic