Baseline country survey on medical devices Croatia Country indicators GDP per capita (2009)* Population (2009)† 14,273.24 4,416,166 Income Group (2010)‡ Region§ High EUR National policy on health technology Health technology (medical device) national policy: Yes, and it is part of the National Health Program/Plan or Policy Web site: http://narodne-novine.nn.hr/clanci/sluzbeni/2006_06_72_1719.html Link to policy document: Language(s): Croatian Regulatory agency Name of principal institution: Agency for Medical Products and Medical Devices, Subunit for Medical Devices Web site: http://www.almp.hr Contact: Krunoslav Kranjcec, [email protected] Telephone number: +385(1)4884327 Medical equipment allocation Technical specification User training Health technology assessment Yes - - Yes Yes - - - - Yes - - Unit/department: - Web site: Contact: - Email: - - - - - Unit/department: - Web site: Contact: - Email: - - - - - Unit/department: - Web site: Contact: - Email: - - - - - National health technology units National health technology unit(s): Yes Unit/department: Agency for Quality and Accreditation in Health Web site: http://www.aaz.hr Contact: Renato Mittermayer, MD Email: [email protected] Unit/department: Direcorate for Financial Affairs Web site: http://www. mzss.hr Contact: Antoaneta Bilic, Email: [email protected] Unit/department: Direcorate of Medical Affairs Web site: http://www. mzss.hr Contact: Dubravko Bajramovic, MD Email: [email protected] Medical device incorporation Procurement Policy or guideline: Yes Web site: http://narodne-novine.nn.hr/clanci/sluzbeni/2007_10_110_3225.html, http://narodne-novine.nn.hr/clanci/ sluzbeni/2008_10_125_3562.html National level procurement: Yes Web site: http://www.mzss.hr Donations Policy or guideline: Yes, developed nationally Web site: http://narodne-novine.nn.hr/clanci/sluzbeni/2009_12_151_3696.html List of approved medical devices for procurement or reimbursement List available: No Unit name: Link to document: Technical specifications Technical specifications to support procurement or donations: No Web site: Link to document: Reference: Due to continuous advancement in medical devices technology, a special commision is formed before every procurement procedure. The commision then defines required technical specifications of the device based on the most recent available dana. http://www.who.int/medical_devices Baseline country survey on medical devices Croatia Inventory and maintenance Type of inventories available: None Link to inventories: Medical equipment management unit: No Healthcare facility National level = 0 Hospital level = 0 Public sector Private sector Total Density per 100,000 population 36 N/A 36 0.8152 Health post Health centre District hospital Provincial hospital Regional hospital Medical devices Regional level = 0 13 N/A 13 0.2944 22 N/A 22 0.4982 29 N/A 29 0.6567 15 N/A 15 0.3397 Public sector Private sector Total Density per 1,000,000 population 15 16 31 7.0197 49 15 64 14.4922 Magnetic Resonance Imaging Computerized Tomography Scanner Positron Emission Tomography Scanner Nuclear medicine Mammograph Linear accelerator Telecobalt unit (Cobalt-60) 0 2 2 0.4529 26 0 26 5.8875 84 40 124 121.2586 10 0 10 2.2644 3 0 3 0.6793 List of medical devices national lists of medical devices for different types of healthcare facilities: Lists available: Yes Web site: http://narodne-novine.nn.hr/clanci/sluzbeni/2004_07_90_1694.html, http://narodne-novine.nn.hr/clanci/ sluzbeni/2008_04_38_1318.html Link to document: National lists of recommended medical devices for specific procedures: Lists available: N/A Web site: Link to document: Other lists recommending health technology: Lists available: a) Communicable high burden diseases?,d) Public health emergency situations (pandemic, acts of terrorism, natural disasters, contamination, etc.)? Web site: http://www.mzss.hr/hr/ministarstvo/strategije_i_planovi/nacionalni_plan_pripremljenosti_za_pandemiju_gripe Link to document: http://www.who.int/medical_devices/survey_resources/medical_devices_for_emergency_influenza_croatia.pdf Medical device nomenclature system Official nomenclature system for medical devices: No Other: Web site: Contacts Focal point Name: Dubravko Bajramovic, MD Position title: Expert Collaborator Department: Directorate of Medical Affairs Email: [email protected] Telephone: +385(1)4698398 Fax number: +385(1)4698486 Postal address: Ministry of Health and Social Welfare, Ksaver 200a, 10000 Zagreb, Croatia * United Nations National Account Main Aggregate Database (2010) † United Nations National Account Main Aggregate Database (2010) ‡ World Bank List of economics (2010) WHO country office Name: Professor Antoinette Kaic-Rak, MD, PhD Email: [email protected] § United Nations geoscheme N/A = not applicable. http://www.who.int/medical_devices
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