Electronic Regulatory Information System

The Ethiopian Food and Drug Administration (EFDA) oversees the market authorization and import permit approval
for both medical and food products for a wide variety of vendors from multiple countries using the Electronic Regula-
tory Information System (eRIS).
The eRIS is an umbrella system comprised of three component sub-systems which work together:
• i-License, which allows entities • i-Register, which is used to • i-Import, which is used to
to apply for a certificate of manage the market authorization manage the import process
competency to register and process where an applicant seeks for medical products, once they
import products into Ethiopia. to register a medical product in are registered in Ethiopia.
Ethiopia for later import.

Import Apply for Certificate of Review

Applicant EFDA
Competency License application

Receive Certificate of Award Certificate of

Competency License Certificate of Competency License
Competency License

Use Certificate of Competency

License to apply to register Review
a product for market application
authorization for import

Receive market
authorization approval Approve registration
Market Authorization
Approval

Utilize market authorization

approval to apply to
import product
Generate
automatic
import
permit
certificate

Import products Approve import

Import Permit
Certificate

Port Officer

Utilize i-Import to clear

imported items at port

Fully online, both applicants and EFDA use eRIS to manage the licensing, registration, and import application process
using this shared portal. This has dramatically increased processing efficiency and transparency and facilitated one
unbroken chain of information – from application to port.