Guidelines for software as medical device and artificial intelligence based medical device

Abstract

The Food and Medicine Administration Proclamation (FMA) 1112/2019 mandates the Food and Drug Authority of Ethiopia (EFDA) to assess the safety, performance and quality of medical devices and give authorization for marketing of the devices in the country. Article 2 sub-article 22 of this Proclamation defines medical device as ‘any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related articles and their accessories intended for medical use’. The scope of this definition and therefore the scope of the Authority’s regulatory control includes non-physical medical devices (i.e. Software) that are intended for medical purpose.