EDA Registration for Medical Devices in Egypt
What is EDA Registration?
EDA Registration is the mandatory regulatory approval issued by the Egyptian Drug Authority (EDA) that allows medical devices and in vitro diagnostic (IVD) products to be legally imported, manufactured, distributed, or marketed in Egypt.
The EDA is the national regulatory authority responsible for ensuring that medical devices placed on the Egyptian market meet established safety, performance, and quality requirements, in line with international regulatory standards
Why EDA Registration is Essential?
EDA registration is legally required for market access in Egypt and ensures regulatory compliance under EDA Chairman Decree No. 450/2023.
Key benefits include:
Legal authorization to sell medical devices in Egypt
Compliance with national regulatory requirements
Increased credibility with hospitals and healthcare institutions
Streamlined approvals for CE-marked devices
For Class II and Class III medical devices, CE certification is strongly recommended and often a prerequisite for successful EDA registration.
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EDA Registration Process for Medical Devices
The EDA registration process typically includes the following steps:
Product Classification
Determine the device class based on intended use and risk level.Technical Documentation Preparation
Compile regulatory documents including risk management, clinical evidence, and performance data.Application Submission
Submit the complete dossier through the official EDA registration portal.Technical Review & Queries
Respond to clarification requests raised by EDA’s technical committee.Approval & Market Authorization
Receive the EDA certificate allowing legal commercialization in Egypt.
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Documents Required for EDA Registration
A standard EDA registration dossier includes:
CE Certificate (preferred for Class II & III devices)
Device description and intended use
Risk Management Report
Clinical Evaluation Report
Labeling and Instructions for Use (IFU)
Manufacturing site information
Quality Management System documentation (ISO 13485 recommended)
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:
Medical device manufacturers
IVD product manufacturers
Importers and distributors of medical devices
Software classified as a medical device
Approval is required regardless of whether the device is low-risk or high-risk.
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How Can Operon Strategist Help in EDA Registration?
Operon Strategist provides end-to-end regulatory consulting services for medical device and IVD manufacturers seeking EDA approval in Egypt. Our expertise includes regulatory strategy, product classification, technical documentation, and compliance with international standards.
Our Services :
Partner with Operon Strategist to simplify your medical device regulatory process in Egypt and accelerate your market access.
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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.