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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...

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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...

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