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- premarket product dossier assessment, Quality Management System Inspection (if applicable), Lab Analysis (if applicable), Distribution control (including import control), and Post-marketing Surveillance. At each control function, the Authority applies a risk-based approach to achieve its goal effectively in a timely manner. One of such approaches is to categorize the products themselves into different risk classes.

The Authority classifies Medical devices other than In Vitro Diagnostic (Non-IVDs) into Class I, II, III, and IV. Class I represents devices with lowest risk level and Class IV represents devices with the highest risk level. Please refer to ‘EFDA’s Non-IVD Classification rules‘ for detail understanding and the associated regulatory guidelines. The IVD Medical devices are also classified on their own as Class A, B, C, and D in which Class A represents the lowest risk and Class D represents the highest risk level. Non-IVD medical devices classification is not included in this article and it is also not in the published guideline (as it has its own separate guideline and you can access it though the above link).

The classification of In Vitro diagnostic medical devices depends on the device’s risk level on the individual and public health. This level of risk is ranked from low individual risk to high public health risk. It is basically based on the level of the health risk that the output from the device may cause if it would be wrong result. The following table gives the risk levels with their examples.

There are seven classification rules with their examples in the Authority’s Regulatory guidelines- ‘Guideline for Classification of In Vitro Diagnostic Medical Devices’. Please refer to the guideline for detail understanding.

The regulatory control by the Authority at all stages (i.e. from pre-market evaluation to post-market control) is applied based on the risk level of the IVD medical devices.

Please contact us for any regulatory consultancy services including- Medical devices Registration with Ethiopian Food and Drug Authority. Write your enquiries with our ‘contact us‘ form or use our official email- keneni@ethiobiomedical.com or ethiobiomedicalinfo@gmail.com .