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.

2 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: 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.)

3 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.

4 Under high cost we mean amounts exceeding EUR 400 Unfortunately the cataster is not a public registry. 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.

5 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. The criteria are equally specified for healthcare facilities ( ) and the specific procedures.

6 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.

7 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: (+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