National Policy for Management of Medical Devices in Albania
(2007; 115 pages)

Abstract

This document describes the health sector policy in the field of management of medical devices in Albania. It reflects the Long Term Strategy for the Development of the Albanian Health System (LTHSD) developed by the Ministry of Health (MoH) and approved by the Council of Ministers in 2004 as well as the Stabilization and Association Agreement (SAA) signed by the Government of Albania and the European Union (EU) in 2006.

In 2004 the Ministry of Health initiated the development of this document with support from Sida and Swedish Health Care. It has been approved by the Ministry of Health in August 2007.

The document describes the technology infrastructure and competence necessary for the use of modern medical devices in the Albanian health care system. It shall serve as a base for development of future legislation concerning medical devices. Also based on this policy document, hospitals and other health care providers will be encouraged to build a local technology infrastructure to support safe and efficient use of medical devices. These guidelines are in line with the European legislative framework for medical devices.

 
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