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Egypt Medical Device Registration

Egyptian Drug Authority (EDA) approval timelines and requirements

2-4 months
Typical Timeline
4
Device Classes
No
MDSAP Accepted
Required
Egypt Authorized Representative

Egypt Medical Device Registration Overview

Egypt medical device registration through EDA typically takes 2-4 months for Class A devices. The official EDA target is 1-3 months, but realistic timelines include preparation, documentation review, and potential questions from regulators.Egypt uses a 4-class (A, B, C, D) risk-based classification system. Foreign manufacturers must appoint a Egypt Authorized Representative to register devices in Egypt. Registration is valid for 5 years.

Registration Timeline by Device Class

Egypt uses a 4-class (A, B, C, D) risk-based classification system.

Class A

Notification

Low Risk
Official
1-3 months
Realistic
2-4 months

• Simplified notification process

Class B

Registration

Medium Risk
Official
3-6 months
Realistic
4-9 months
With Prior Approval
3-5 months

Accelerated with: FDA, EU CE Mark

• Technical documentation required

GMP/QMS Required

Class C

Registration

High Risk
Official
4-8 months
Realistic
6-12 months
With Prior Approval
4-7 months

Accelerated with: FDA 510(k), EU CE Mark

• Clinical evidence may be required

GMP/QMS Required

Class D

Full Registration

Highest Risk
Official
6-12 months
Realistic
9-18 months
With Prior Approval
6-10 months

Accelerated with: FDA PMA, EU CE Mark Class III

• Clinical data required

Clinical Trial RequiredGMP/QMS Required
Prior Approval Recognition

Existing approvals from other regulatory authorities can accelerate your Egypt registration.

FDA 510(k)
Expedites documentation review
2-4 months
EU CE Mark
Recognized for expedited review
2-4 months
Key Requirements
  • Egypt Authorized Representative
  • Arabic labeling
  • ISO 13485 certification
  • Free Sale Certificate
  • Technical documentation
Registration Validity:

5 years

Registration Process Flowchart

Egypt Medical Device Registration Process

Step-by-step EDA registration process. Total estimated timeline: 2-4 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by EDA. Appoint a Egypt Authorized Representative.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to EDA including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

EDA reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

1-3 months

In-depth technical assessment of device safety and performance. EDA may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, EDA issues Egypt market authorization certificate.

Summary: The Egypt medical device registration process through Egyptian Drug Authority (EDA) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.
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Related Resources
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Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.