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Ethiopia medical device registration resources

Research EFDA registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Ethiopia medical device resource.

4 free resources23/25 topics with records9 regulations trackedSep 2026 fees reviewed
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Medical device regulations

Browse Ethiopia's official medical-device instruments — EFDA's marketing-authorisation, registration, classification, labelling, vigilance, post-approval-change and reliance guidelines, and the import-export directive — with citeable Amharic and English passages.

Structured regulatory requirements

Explore all 53 source-linked facts →

23 of 25 research dimensions currently covered · 26 official sources · latest verification 2026-09-16

Market entry

D01

Authority & regime

Verified
EFDA is the national competent authority for medical device registration and marketing authorisation
The Ethiopian Food and Drug Authority (EFDA) is mandated to safeguard the health and safety of patients and users by assessing the quality, safety and effectiveness of medical devices prior…
1 source-linked fact
Checked 2026-09-16
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D02

Legal basis & guidance

Verified
Food and Medicine Administration Proclamation No. 1112/2019, implemented through the EFDA GDL guideline series
The primary instrument is the Food and Medicine Administration Proclamation No. 1112/2019. Article 20(1) mandates registration and marketing authorization of medical devices; Article 19(1)…
1 source-linked fact
Checked 2026-09-16
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D03

Device definition & scope

Verified
Products expressly outside the device definition
EFDA states expressly which borderline products it does not regulate as medical devices: products that do not fulfil the Art. 2(22) definition are not considered a medical device and are no…
Standalone software and AI-based software are regulated as devices
EFDA regulates standalone software and artificial intelligence based software as medical devices. Software as a Medical Device (SaMD) is defined as software intended to be used for one or m…
3 source-linked facts
Checked 2026-09-16
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D04

Classification rules

Verified
EFDA Classes I, II, III and IV
Class I, Class II, Class III, Class IV
1 maintained scheme · 1 related fact
Checked 2026-09-16
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D05

Registration pathways

Verified
Four marketing authorisation routes: full assessment, SRA/prequalified, low-risk abbreviated, and IVD registration
EFDA operates four device marketing authorisation routes. (1) Full assessment for all non exempt devices that are neither low risk listed nor SRA/prequalified: a complete dossier filed unde…
1 source-linked fact
Checked 2026-09-16
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D06

Reliance & recognition

Verified
For low-risk devices a CE certificate replaces the free-sale / marketing authorisation certificate
statement: In the low risk device route (Class I non IVD and Class A IVD), EFDA states that if the applicant submits a CE certificate, the free sale certificate or marketing authorisation c…
China NMPA is not among EFDA's recognised SRAs, so an NMPA approval confers no shortened route
statement: EFDA's SRA route enumerates exhaustively the foreign authorities whose marketing authorisation, registration certificate or free sale certificate makes a device eligible (US FDA,…
6 source-linked facts
Checked 2026-09-16
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D07

Economic-operator roles

Verified
An overseas manufacturer must appoint an Ethiopian local agent by written agency agreement before registration
Before a medical device can be registered for use in Ethiopia an overseas manufacturer must sign an agency agreement with a local agent established in Ethiopia who acts on its behalf for re…
1 source-linked fact
Checked 2026-09-16
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D08

Establishment, import & distribution

Verified
Distributors may sell or distribute only to authorised persons
The device good storage and distribution guideline applies to all parties in the medical device supply chain in Ethiopia, including manufacturers, importers, wholesalers and retail outlets.…
Importers, exporters and wholesalers of medical devices need an EFDA establishment licence
Any person who wants to import, export or wholesale medicine and medical device in Ethiopia must first obtain a certificate of competence from the Ethiopian Food and Drug Authority. Directi…
3 source-linked facts
Checked 2026-09-16
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D09

Dossier requirements

Verified
Non-IVD dossier: administrative chapter plus technical chapters covering description, evidence and labelling
The non IVD registration dossier (GDL/097) is filed in two parts. The administrative chapter requires a stamped and signed cover letter, the agency agreement, evidence of the registration a…
1 source-linked fact
Checked 2026-09-16
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D10

Official forms & portals

Verified
Applications are filed through the eRIS registration platform; establishment licences through the ilicense portal
Device registration and marketing authorisation applications are submitted online through EFDA's Electronic Regulatory Information System (eRIS) at www.eris.efda.gov.et, after obtaining a u…
1 source-linked fact
Checked 2026-09-16
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Submission & evidence

D11

Label, IFU & language

Verified
Labelling and instructions for use must be in English and/or Amharic
All medical device labelling must be in English and/or Amharic, and labels must be legible, indelible and not easily detachable; any product information on the labelling must be based on sc…
1 source-linked fact
Checked 2026-09-16
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D12

QMS, audit & inspection

Verified
GMP inspection programme applies to foreign and local manufacturers
The EFDA medical device GMP site inspection programme applies to medical devices to be registered with the Authority that are subject to GMP inspection, and it applies to both foreign and l…
QMS assessment depth and on-site audit by risk class
EFDA's conformity assessment of the manufacturer's QMS depends on the device class. Manufacturers of Class I devices and Class A IVDs must implement and maintain the basic elements of a QMS…
3 source-linked facts
Checked 2026-09-16
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D13

Standards, testing & ancillary approvals

Unresolved
ECA type approval of radiocommunications and telecommunications equipment
Wireless / radio
ECA approval of equipment connected to a telecommunications network
Telecom terminal
Electrical safety and mechanical/environmental protection evidence in the EFDA dossier
Electrical safety
5 maintained overlays · 3 related facts
Checked 2026-09-16
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D14

Fees

Verified
New application screening
ETB 350
New application evaluation
ETB 1300
5 maintained fee lines · 1 related fact
Checked 2026-09-16
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D15

Review clocks

Unresolved
Certificate of competence for importers, exporters and wholesalers is issued within five working days once requirements are met
Once the inspection confirms that an applicant importer, exporter or wholesaler of medicines and medical devices fulfils the requirements, the Authority issues the certificate of competence…
Statutory complaint clocks: 30 working days to lodge, 60 working days for the complaint handling organ to decide
A regulated person who considers an administrative measure on its product or institution, or the denial of a legitimate service under the Proclamation, inappropriate, disproportionate or il…
3 source-linked facts
Checked 2026-09-16
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D16

Approval validity & renewal

Verified
Marketing authorisation is valid five years; re-registration opens three months before expiry
Marketing authorisations granted by EFDA are valid for five years and must be renewed every five years. The option to apply for re registration opens when three months remain before the cer…
1 source-linked fact
Checked 2026-09-16
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Lifecycle & post-market

D17

Change control

Verified
Post-approval changes are classified into three categories with different submission and implementation rules
EFDA classifies post approval changes to a registered medical device into three categories. Category 1 changes are critical changes that require a new pre market product registration applic…
1 source-linked fact
Checked 2026-09-16
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D18

UDI, listing & traceability

Verified
Barcode required on the labelling of any device imported or put into use
The statute prohibits any person from importing or placing into use any medicine or medical device unless its labelling contains a barcode. This is a statutory labelling requirement and is…
Traceability records must enable product withdrawal from the market
The manufacturer must document traceability procedures covering at least the origin of the product, material and parts, the history of processing, distribution and the product location afte…
3 source-linked facts
Checked 2026-09-16
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D19

Clinical investigation & performance

Verified
Clinical data generated in other jurisdictions accepted in the clinical evaluation
EFDA states that a proper clinical evaluation demonstrates which clinical data are necessary and can be adequately contributed to by sources such as literature searching, prior clinical inv…
IVD clinical performance claims and who may generate the evaluation
For in vitro diagnostic medical devices, all claims for the clinical performance of the product must be supported by well designed performance evaluations. EFDA accepts evaluations that hav…
3 source-linked facts
Checked 2026-09-16
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D20

Special access & derogation

Verified
Statutory permit for import or use of an unregistered device
Notwithstanding the general prohibition on importing, manufacturing, storing, distributing, transporting, selling, holding, using or transferring an unregistered and unauthorised device, th…
Personal use and custom made device import without a pre-import permit
An individual who wants to import medical products for personal use or a custom made medical device must have a prescription paper from an authorised health professional indicating the type…
4 source-linked facts
Checked 2026-09-16
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D21

Manufacturer PMS

Verified
Manufacturer must run PMS with a documented procedure and a plan
EFDA places the post market surveillance obligation on the manufacturer: manufacturers must perform post market surveillance to continuously monitor their medical device and report findings…
Periodic safety summary reporting and trend reports
EFDA may accept periodic summary or trend reports from a manufacturer or authorised representative after one or more initial reports have been issued and evaluated, on a format and frequenc…
2 source-linked facts
Checked 2026-09-16
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D22

Vigilance & incident reporting

Verified
Manufacturer incident reporting deadlines: 2 days for serious public health threat, 10 days for death or serious incident, 30 days for other incidents
Once a manufacturer becomes aware that one of its devices may be associated with an adverse event or incident it must report to EFDA within the following deadlines: serious public health th…
1 source-linked fact
Checked 2026-09-16
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D23

Recall, FSCA & market surveillance

Verified
Field safety corrective action notification and Field Safety Notice content
Once the manufacturer or its authorised representative has identified the problem and determined that an FSCA is needed for a non conforming device, the manufacturer or its authorised repre…
Authority may order recall and stop distribution of a marketed device
Where a regulated product is in contravention of applicable laws and its use or exposure will have adverse health consequences or would result in death, the responsible person may be ordere…
3 source-linked facts
Checked 2026-09-16
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D24

Advertising, claims & promotion

Verified
Advertising or promoting devices within a health institution requires permission
Ethiopian law makes it illegal to advertise medicine and medical devices or to promote within a health institution unless the appropriate executive organ grants permission to the advertisem…
In-person promotion to health professionals only through an authorised device promoter
Any direct advertisement or promotion made in person to a health professional must be made through a medicine or medical device promoter who is duly authorised by the executive organ. The s…
3 source-linked facts
Checked 2026-09-16
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D25

Submission communications & appeal

Verified
Review of a decision, complaints and the certificate correction window
Applicants can request a review of a decision or appeal their complaints after a market authorization certificate is granted, in accordance with the complaint handling procedure set by the…
Deficiency response rounds and the grounds that end an application
EFDA's device dossier assessment model is that the review is completed on the basis of the information submitted, a list of questions is then sent to the applicant setting a specified time…
2 source-linked facts
Checked 2026-09-16
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Government fees

Full fee schedule (5 lines) →

EFDA registration fees in ETB · reviewed 2026-09-16

Fee lineAmountProvenance
New application screeningETB 350Verified
New application evaluationETB 1300Verified
Renewal application evaluationETB 870Verified
Major variation application evaluationETB 870Verified
1 more fee lines on the full schedule · 5 of 5 rows source-verified

Key regulations

All 9 Ethiopia regulations →

Official EFDA rules and guidance · 9 of 9 documents linked to official sources

Directive No. 872/2014 E.C. (872/2022)Medicine and Medical Device Import, Export and Wholesale Control Directive No. 872/2022
GeneralVerified
EFDA/GDL/041 Version No: 002Guideline for Classification of Medical Devices Other than IVD Medical Devices (EFDA/GDL/041)
ClassificationVerified
EFDA/GDL/042 Version No: 003Guidelines on Reliance for Medicine Marketing Authorization (EFDA/GDL/042)
GeneralVerified
EFDA/GDL/046 Version No: 005General Guidelines for Marketing Authorization of Medical Devices (EFDA/GDL/046)
RegistrationVerified
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