Tag Archive : Ethiopian Food and Drug Authority

Ethiopian Food and Drug Authority (EFDA) Medical device GMP/QMS Onsite Inspection

Medical device manufacturing sites’ Quality management system audit by Ethiopian Food and Drug Authority

Ethiopian Food and Drug Authority is a governmental organization mandated by Food and Medicine Administration Proclamation 1112/2019, that has been in effect since February 2019, to ensure a high level of protection of public health and safety. Public trust and … Read More

Guideline for IVD Medical devices Registration Requirements_Flowchart

Guidelines for “Registration Requirements of In Vitro Diagnostic Medical Devices”

In order to fully understand EFDA’s comprehensive registration requirements and make request for the Marketing Authorization of In vitro diagnostic medical devices, I recommend you to download and read the guideline that is attached below (in PDF format).

Here, I … Read More

Guidelines for “Registration Requirements of Medical Devices other than In Vitro Diagnostic Devices”

In order to fully understand EFDA’s comprehensive registration requirements and make request for the Marketing Authorization of Non In vitro diagnostic medical devices, I recommend you to download and read the guideline that is attached below (in PDF format).

Here, … Read More