Category Archive : Blogs

Medical device market in Ethiopia

Medical Devices and In Vitro Diagnostic Medical Devices Market Opportunities in Ethiopia

Ethiopia's journey towards economic prosperity and improved healthcare has been marked by significant progress in recent years. With the goal of attaining lower-middle-income status by 2025, the Government of Ethiopia introduced the ambitious 10 Years Perspective Plan (2020/2021 to 2029/2030). … Read More

Medicines and medical devices special import permit by Ethiopian Food and Drug Authority

Medicines and medical devices special import permit by Ethiopian Food and Drug Authority

This blog simplifies the Ethiopian Food and Drug Authority's (EFDA) guideline on obtaining a special import permit for medical products.

Ensuring Access to Critical Medical Products

The healthcare system relies on a steady flow of vital medical products. But sometimes, … Read More

Identification of Borderline Medical devices from Medicinal products_Ethiopian FDA

Identification of Borderline medical devices from medicinal products.

The world of medical products can be complex, especially when it comes to borderline products that blur the lines between medical devices and medicinal products. This ambiguity can pose challenges for manufacturers and healthcare professionals alike. This article aims to … Read More

Low risk medical device registration in Ethiopia

Simplifying Medical Device Approval in Ethiopia: A Guide to Low-Risk Devices Registration

The Ethiopian market is seeing a rise in medical devices, and ensuring their safety and effectiveness is crucial. The Food and Medicine Administration Proclamation No. 1112/2019 plays a key role in this by requiring registration for all medical devices. But … Read More

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

The-decision-flowchart-for-grouping-of-products-as-an-IVD-Test-kit

How to group or bundle medical devices and submit in one application to register with EFDA

From 2018 on, Food and Drug Authority (FDA) of Ethiopia started implementing the rules of appropriate bundling of different medical devices into a single registration request application. Bundling or grouping devices is a very important strategy to enable the assessors … 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