Hungary - WHO

1 Atlas of medical devices - 2014 Global atlas of medical devices - 2014 HungaryCountry indicatorsNational policy on health technologyHealth technology ( medical device) national policy: Yes, and it is part of the National Health Program/Plan or PolicyWeb site: (s): HungarianMOH responsible for health technology policy implementation: Regulatory agencyAuthority responsible for implementing and enforcing regulations in your country: YesName of principal institution: Office of Health Authorisation and Administrative Procedures - Authority for medical DevicesWeb site: : Gy rgy Ferenc BALAZST elephone number: (+36) 130250 60 Email: health technology assessment unitUnit/department: National Institute for Strategic Health Research - Office of Health Technology AssessmentWeb site: : Dr. Marta PekliEmail: health technology management unitsNational health technology unit(s): YesDevelopment of technical specifications for procurement process:Unit/department: National Health Insurance Fund - Departement of Benefits In kindWeb site: : Kiss ZsoltE mail: Unit/department: Web site: Contact: Email: other: Unit/department: Web site: Contact: Email: medical device nomenclature system Official nomenclature system for medical devices : Yes Type: Nationally developed Use: Not specifiedNomenclature system name: ORKI-k d (ORKI CODING) Web site: medical device incorporationprocurementPolicy or guideline: YesWeb site: level procurement: YesWeb site: or guideline: NoWeb site: technical specificationsTechnical specifications to support procurement or donations: NoWeb site.

2 Population (000s)*9 955 Life expectancy at birth (years) 75 World Bank income group Upper-middleInternet users (%) capita total health expenditure (PPP Int $) 1729 GNI per capita (US$) 13 260 medical device incorporation comments : For procurement guidelines see the Decree of the Minister of Welfare (No. 9/1993 NM) on the specific aspects of financing of healthcare insurance services. In respect of certain medical devices procured at national level over a certain amount, procurement is carried out by the Central Services Directorate General of the Prime Minister s the reamining cases hospitals procure medical devices subject to itemized accounting (see first list in the file uploaded under question , but with exception of pacemakers, heart valves, cochlear implants) atlas of medical devices - 2014 Inventory and maintenanceType of inventories available: National inventory only for high cost technologies (such as MRI, CT or PET scanners)Comments: Under high cost we mean amounts exceeding EUR 400 Unfortunately the cataster is not a public registry.

3 Access is ensured only for data providers, manufacturers and conformity assessment equipment management unit: NoManagement software: YesSoftware and comments : Most of the public instititions use the software CT-EcoSTATL ists of medical deviceslists of approveD medical devices for public procurement or reimbursement:Lists available: YesUnit: National Health Insurance Fund / Central Services Directorate General of the Prime Minister s Office, respectivelyWeb site: national lists of medical devices for Different types of healthcare facilities or specific proceDures: Lists available: For different healthcare facilities and specific proceduresWeb site - facilities: Web site - procedures: national list for Diseases anD situations: Lists available: One or moreWeb site: : Additional information and comments :Concerning HT policies: Safety and Partnership Program - a health program adopted by the Hungarian government on 9 July 2008 - the acceptance of medical devices and health technologies into the social insurance scheme was defined level = 0 Regional level = 0 Hospital level =0 Lists comments :The uploaded ministerial decree lays down the minimum requirements for the provision of healthcare services.

4 The criteria are equally specified for healthcare facilities ( ) and the specific procedures. This is why we have uploaded the document only once (available in Hungarian). The assigned URLs contain protocols for pandemic situation according to the National Communicable diseasesNon-communicable diseasesInjuriesPublic health emergency situationsxHealthcare facilityPublic sectorPrivate sectorTotal Density per 100,000 populationHealth post577 centre11 hospital74 hospital17 hospital11 equipmentPublic sectorPrivate sectorTotalDensity per 1,000,000 populationMagnetic Resonance Imaging Tomography Emission Tomography * unit (Cobalt-60) * Density per 1,000,000 females aged from 50-69 pointName: Mrs Zs fia B lint-PatakiPosition title: counsellorDepartment: Department for Pharmaceuticals and medical DevicesEmail: (+36) 1 795 1114 Postal address: H-1051 Budapest Arany J nos utca 6-8 WHO representive:Name: Dr Zs fia PusztaiEmail: health products focal point:Name: Email.

5 (+36) 1 328 60 80 WHO European Region* UNPD as of 1 July 2012 (2013 update) WHO 2012 data WB 2014 classification WB 2013 data (2014 update) WHO 2012 data WB 2013 (2014 update)n/a not applicable The full text can be found at