Medical Devices Regulation

To safeguard public health, Ethiopia has introduced a directive regulating the importation, manufacturing, and distribution of medical devices.

Key Provisions:

Mandatory Registration: All medical devices must be registered with the Ethiopian Food and Drug Authority before entering the market.

Quality Standards: Devices must meet international certifications such as ISO and WHO guidelines.

Market Surveillance: Regular inspections and audits will be conducted to prevent counterfeit or unsafe products.

Transparency Requirements: Manufacturers must disclose clinical trial data and product safety information.

Implications:

This directive enhances patient safety, strengthens Ethiopia’s healthcare system, and builds trust in medical technology.

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