Unit for Medical Systems and Devices at Ministry of Health Submitted by Name: Ledina Picari Affiliation: CED Collaborator Location: Tirana, Albania E-mail address for contact: ledinapicari@yahoo.com

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

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 Global CE / HTM Success Stories

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 2010 - 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 Global CE / HTM Success Stories

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 Global CE / HTM Success Stories

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 Global CE / HTM Success Stories

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