Category Archive : Guidelines

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

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