Medical Device Registration and Approval in Ethiopia

General country-specific regulatory information is provided on this page for medical device registration and approval in Ethiopia. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Ethiopia, to expedite the preparation of your medical device or IVD registration application.

 

Medical Device Regulations and Classification in Ethiopia

REGULATORY AUTHORITY: Medical devices are regulated by the Food, Medicine and Health Care Administration and Control Authority (FMHCACA).

CLASSIFICATION SYSTEM: Devices are classified according to risk.

Medical Devices: Class I (lowest risk), Class II and Class III (highest risk)

IVD Devices: IVD devices are classified similarly, with Class A as the lowest risk and Class D as the highest.

TIME FRAME: Medical devices are licensed within 90-180 days.

Class I: The registration process takes about 90-180 days.

Class II: The registration process takes about 90-180 days.

Class III: The registration process takes about 90-180 days.

SPECIAL REQUIREMENTS:

Audits: There are no audit requirements, however,  the authority has the right to conduct an audit at any time.

Technical Local Tests: For IVDs, like Rapid test kits and blood glucose meters;  independent laboratory evaluation is required. For sterile products; there is a requirement to check the sterility of the products. For condoms; there is a testing requirement. Additional tests may be required.

Clinical Evaluation/studies: No clinical evaluation is required.

Other: Other testing is required for select products like a glucose meter, for example.

LOCAL FEES: Various fees apply.

Agency agreement fee: $50 USD

Pre-screening fee: $15 USD (1st), $15 USD (2nd), $20 USD (3rd)

Evaluation fee: $50 USD per site

Testing Fee: Independent lab fees differs from lab to lab, these range from $200 – $400 USD per kit

Sterility Testing: $200 USD per product

LICENSE VALIDITY: Licenses issued in Ethiopia are valid for four years.

LICENSE TRANSFER: License transfers are allowed with submission of the correct documents.

AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: An authorized representative is required.

Last Updated on April 1, 2019.

 

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