How EFDA classifies devices
EFDA uses a risk-based classification: the higher the risk, the more evidence it asks for. Many low-risk devices (Class I / A under EFDA's classification) fall under a simplified low-risk listing, with some exceptions.
In-vitro diagnostics (IVDs) such as rapid tests, reagents and analysers are regulated as medical devices, with their own risk classes.
Documents you'll typically need
- A signed and stamped application form.
- An authorised-representative (local agent) agreement, notarised or legalised.
- A Certificate of Free Sale from a recognised regulator in the country of origin.
- Technical documentation matching the device's risk class.
Check EFDA's current device guideline for the full list for your class before submitting.
Submitting and after approval
Applications are submitted online through eRIS by your local agent. Once registered, importers can apply for import permits for the device.
Use the category pages to see which importers bring in devices like yours today, and which foreign manufacturers they already work with.
Frequently asked questions
Are diagnostics (IVDs) regulated as medical devices in Ethiopia?+
Yes. Rapid tests, reagents and analysers are registered with EFDA as medical devices, under a risk-based classification.
Is there a simpler route for low-risk devices?+
Yes. Many Class I / A devices are eligible for EFDA's low-risk listing, which asks for less evidence than higher-risk devices.
Do I need a Certificate of Free Sale?+
Typically yes, from a recognised regulator in the device's country of origin.
Official sources
This guide is general information, not legal or regulatory advice. Always check EFDA's current guideline before you submit.