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.
