Author: Keneni

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

How do Local Innovators of COVID-19 related Medical Products get support and approval for their products?

How do Local Innovators of COVID-19 related Medical Products get support and approval for their products?

Since WHO declared COVID-19 as Public Health Emergency of International Concern, all countries have been putting all their efforts together to fight this pandemic.

Ethiopia, being the second most populous country in Africa and one of the most vulnerable countries … Read More

EFDA's quick assessment and approval system for COVID-19 related medical devices

EFDA’s Interim Quick Assessment (IQA) system for Medical devices which are listed as ‘high priority devices’ due to COVID-19

The issue of CoronaVirus Disease (COVID-19) has now become beyond everything else. This is due to the disease's feature of easy spreading, no enough diagnosis, no known treatment, no enough Personal Preventive Equipment (PPE) across the world. This makes the … Read More

Medical Devices Regulation and their registration processes in Ethiopia is now getting clearer and easier than before. This article helps you know through step by step.

Regulation of Medical Device and its registration procedures in Ethiopia

selecting the project topic for engineering students

How to decide final year project topic – for Engineering Students

I have been asked a lot of questions on how to decide “new and innovative project or research topic” by so many Engineering students from different areas especially Biomedical Engineering personally and through inbox. Most of these questioners ask for … Read More