Author: Keneni

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 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, distribution, use to disposal. These regulatory controls are divided into different sequential regulatory functions/pathways- … 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

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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