Author: Keneni

The IVD medical devices assessment scrutiny increases with the devices' risk class

In Vitro Diagnostic medical devices Classification in Ethiopia (by Ethiopian FDA)

In order to permit the marketability of medical devices in the Country, the Ethiopian Food and Drug Authority (EFDA) exercises different regulatory controls from their manufacture to disposal. These regulatory controls are divided into different sequential regulatory functions/pathways- premarket product … Read More

Risk-classification and Regulatory controls of Non-In Vitro Diagnostic Medical devices

Guidelines for Classification of Medical devices other than In Vitro diagnostic medical devices

In order to permit the marketability of medical devices in the Country, the Ethiopian Food and Drug Authority (EFDA) exercises different regulatory controls from their manufacture to disposal. These regulatory controls are divided into different sequential regulatory functions/pathways- premarket product

Read More
EFDA IVDs regulatory pathways

Regulatory Process of In Vitro Diagnostic Medical devices in Ethiopia

Ethiopian Food and Drug Authority (EFDA) is a national regulatory body mandated to regulate food, medical products, tobaccos, and other similar products in the country before being distributed/marketed and used. Therefore, all devices which fulfil the medical device definition provided … Read More

Food and Medicine Administration Proclamation (No- 1112_2019)

Food and Medicine Administration Proclamation No: 1112/2019

If it is to achieve a consistent success, the primary task of any business entity should be being legally acceptable. I want you to know the legal principle- “Ignorance of the law excuses no man from practicing it”. … 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

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