EDA Registration
What is EDA Registration?
EDA Registration is a mandatory regulatory requirement for medical device and in vitro diagnostic (IVD) manufacturers, distributors, and importers seeking market access in Egypt.
The Egyptian Drug Authority (EDA) regulates this process to ensure that all medical devices meet essential safety, performance, and quality standards — safeguarding public health while supporting Egypt’s growing medical manufacturing sector.
Operon Strategist provides complete regulatory consulting services to help businesses successfully obtain EDA approvals and navigate Egypt’s medical device regulatory framework with ease.
Why EDA Registration is Essential
Legal market entry in Egypt
Compliance with EDA Chairman Decree 450/2023
Enhanced product credibility for healthcare providers and institutions
Faster approvals with internationally recognized CE Marking
Let's Grow Your Business Together
For Class II and III devices, CE certification is highly recommended — and often a prerequisite for EDA registration.
Learn more about: CE Marking for Medical Devices in Egypt.
Steps in the EDA Registration Process
Product Classification: Identify device category based on intended use and risk.
Technical File Preparation: Prepare essential documents including risk management, clinical data, and performance evaluation.
Application Submission: Submit the dossier via the EDA Registration Portal.
Technical Review & Queries: Address EDA’s technical committee clarifications, if any.
Approval & Certification: Receive market authorization certificate for legal sales and distribution.
👉 View the official Checklist for EDA Product Registration.
Submit an Inquiry for Eda Approval Assistance
Documents Required for EDA Registration
CE Certificate (highly preferred)
Device Description & Intended Use
Risk Management Report
Clinical Evaluation Report
Labelling & Instructions for Use
Quality Management System (ISO 13485 recommended)
For a full dossier outline, refer to EDA’s Guideline on Dossier Requirements.
Medical Device Classification in Egypt:
The Egyptian Drug Authority (EDA) follows European risk–based classification system for medical devices. The medical device must have a CE mark to be placed in the Egyptian market. A CE mark will help to get registration approval from CAPA. Medical devices are classified into four categories namely:
Classification Type | Risk | Example |
Class I | Low | Tongue depressor, stethoscopes for diagnosis, non –invasive electrodes |
Class II A | Low-Moderate | Infusion pumps, syringes, Anaesthesia breathing circuits |
Class II B | Moderate- High | Orthopaedics implants, long term corrective contact lenses, insulin pens |
Class III | High | Coronary stents, spinal stents, breast implants |
Who Requires EDA Registration?
EDA registration is mandatory for:
- Manufacturers of Class I, II, or III medical devices.
- Producers of in vitro diagnostic (IVD) products.
- Distributors or importers of medical equipment and software.
Whether your products are low-risk Class I devices or high-risk Class III devices, obtaining EDA approval is a prerequisite to accessing the Egyptian medical device market.
Ensure Fast and Hassle-Free EDA Registration With Our Expert Guidance
How Can Operon Strategist Help in EDA Registration?
Operon Strategist offers expert regulatory consulting for medical device and IVD manufacturers seeking EDA approval in Egypt. We assist with regulatory strategy, product classification, and design & development documentation to ensure local compliance.
Our Services :
Partner with Operon Strategist to simplify your medical device regulatory process in Egypt and accelerate your market access.
Need EDA Registration? Let’s Get You Approved!
With 12+ years of expertise and 200+ successful registrations, we handle everything—classification, documentation, and approvals. Let us save your time and streamline the process for MD 14, MD 26, or MD 15 licenses.
Ready to start? Fill out the form and let’s make it hassle-free!
Mail Us:
Call Us Now:
Submit Your Details for EDA Support Today!
FAQ'S
What is EDA registration for medical devices in Egypt?
EDA registration is the regulatory approval process required by the Egyptian Drug Authority (EDA) for placing medical devices and in-vitro diagnostics on the market in Egypt. It ensures the safety, performance, and quality of medical devices.
Who needs to apply for EDA registration in Egypt?
Manufacturers, distributors, and importers of medical devices and IVDs intending to market their products in Egypt are required to obtain EDA registration before commercial distribution.
How long does the EDA Registration process take?
The timeline varies depending on the device classification and completeness of the submission, but it generally ranges from a few weeks to several months.
What documents are required for EDA medical device registration in Egypt?
The documentation typically includes a device description, technical dossier, quality certificates (like ISO 13485), CE marking or FDA approval evidence if applicable, clinical data, labeling samples, and an application form as per EDA requirements.
Which medical devices require EDA Registration?
All classes of medical devices, including in-vitro diagnostics (IVDs), require registration with the EDA before import, distribution, or sale in Egypt.