Basic Aspect for Specify the Medical Device

Abstract

Medical devices cover a variety of products designed to diagnose and treat patients. These devices range from a simple medical glove to a complicated Magnetic Resonance Imaging machine (MRI). However different their composition may be, medical devices are all designed with the purpose of improving patient care. The proportion of the rapid development and increasing complexities of electronics of medical devices, in addition to fact that 85% of medical dictions depend on a medical device, regulation and management of medical devices become most challenge term in healthcare process to ensure patient safety by identify risks and benefits of each medical device. Lack and weakness of authority and lows which manage regulation process and procedures shows clearly in the third world countries (Sudan). This research is an attempt to optimize medical devices regulation and control in Sudan by communion with the competent authority and highlight the shortcomings and their causes. Also attempt to keep up the international standards and procedures applied in other develop countries and their organizations