Croatia - World Health Organization

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, krunoslav.kranjcec@almp.hr
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: renato.mittermayer@aaz.hr
Unit/department: Direcorate for Financial Affairs Web site: http://www.
mzss.hr
Contact: Antoaneta Bilic, Email: antoaneta.bilic@mzss.hr
Unit/department: Direcorate of Medical Affairs Web site: http://www.
mzss.hr
Contact: Dubravko Bajramovic, MD Email: dubravko.bajramovic@mzss.hr
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: dubravko.bajramovic@mzss.hr
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: a.kaic-rak@wholo.hr
§ United Nations geoscheme
N/A = not applicable.
http://www.who.int/medical_devices