1. Unit for Medical Systems and Devices at Ministry of Health
Submitted by
Name: Ledina Picari
Affiliation: CED Collaborator
Location: Tirana, Albania
address for contact:

2. Country Estimates in Brief
Population
The population of Albania on January 1st, 2015 was 2,893,005 
Population Growth Rate
0,546%
Life Expectancy at Birth
80,3 – females
76,1 - males
Infant Mortality Rate
9.3/1000 (live births under 1 year)
Number of Health Centers in Country
580 primary health care centers (56 specialty centers)
5 - University Hospitals
11 - Regional
23 – District
Total Expenditure on Health as % of GDP
2.8% of GDP (2015) from state budget, 6% in total including private sector
Global CE / HTM Success Stories

3. Global CE / HTM Success Stories
Structural organisation at Ministry of Health of Albania regarding the medical devices - BEFORE
No department or unit for medical devices before 2010
2004 – One electronic engineer in the Department of Procurement and Investment, employed as Procurement Specialist:
Main tasks:
- Preparation of technical specifications for the medical devices
- Evaluation of bids to define the compliance with the technical specifications
2009 – One biomedical engineer at Hopital Planning Department (I applied to be transferred to Hopital Planning Department. This new position was the first step towards the establishment of the future Unit)
Defing priorities and planning the supply of hospitals with medical devices
Preparing technical specifications and participation in the evaluation committees
- Distribution of medical devices, donated by various filantropic associations
- Inspection of their functionality and other issues related to medical devices
March 2016
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4. Global CE / HTM Success Stories
Country's Health Technology Program What we did... Structural organisation at Ministry of Health of Albania regarding the medical devices - NOW
From Management and Standartisation of Health Technologies Unit established as part of Hospital Planning Department, now Unit for Medical Devices and Systems as part of Information Technology and Medical Systems Department
- Head of the Unit is a Biomedical Engineer
- The Unit is responsible for the overall supervision of medical devices in the health care sector.
- The mission of the Unit is to increase patient and user safety through policies and action plans.
March 2016
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5. DUTIES AND RESPONSIBILITIES OF THE UNIT
Design of laws and sub-laws, orders of the Minister, policy documents, recommendations and guidelines regarding the use, management and maintenance of medical devices as part of policy making process
Preparation and/or approval of medical devices technical specifications, aiming the standardisation of the health technology used in public hospitals in the country.
Wholesale and retail distribution authorisation provision for the economic operators.
Management and participation in the process of the adverse event reporting process
Preparation of the process of medical device recalls or limitation in their use when incidents related to safety are encountered
Participation in working groups for health technology budget planning.
Participation in procurement procedures when complex and sophisticated technology is procured centrally (CT’s, MRI’s, etc.) at Ministry of Health.
Defining actions for improvement of health systems functionality in accordance with Ministry of Health health policies
March 2016
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6. Global CE / HTM Success Stories
Outcomes
The first Albanian Law on Medical Devices No. 89/2014 approved. It was prepared by the Unit in collaboration with the Law Department
The law:
- regulates the circulation of medical devices in Albanian market
- improves the safety for the patients and users
- defines the legal responsibilities
Three technical regulations in approximation of the three European directives are approved
       - Directive 93/42/EEC for “Medical Devices”
      - Directive 98/79/EEC "On the diagnostic in vitro medical devices"
   - Directive 90/385/EEC “On implantable medical devices”
New approach toward maintenance of medical devices improving high technology diagnostics access
Increase of safety of patients and users through medical device technology selection
Better planning and purchases of medical devices for regional hospitals improving the health service at national level
March 2016
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7. Conclusions and Action Plan
Further legislation development & implementation especially for market surveillance
Investments in state-of-art technology in medical devices and systems
Human capacity building
Better health technology management
Regulations on maintenance of medical devices
March 2016
Global CE / HTM Success Stories