EDA Registration
What is EDA Registration?
EDA Registration is a mandatory regulatory requirement for all medical device and in vitro diagnostic (IVD) manufacturers, distributors, and importers aiming to place their products in the Egyptian healthcare market.
The Egyptian Drug Authority (EDA) oversees this regulatory process to ensure every medical device meets the essential safety, performance, and quality standards that safeguard public health and support Egypt’s expanding medical technology sector.
At Operon Strategist, we provide complete regulatory consulting solutions to help medical device companies successfully obtain EDA approval and ensure full compliance with Egyptian Drug Authority regulations.
Why EDA Registration is Essential for Medical Device Companies?
Securing EDA Registration is not just a formality — it is a critical step to ensure legal market entry and regulatory compliance in Egypt.
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Legal Authorization for Market Entry – EDA approval is mandatory for medical device distribution and sales in Egypt.
Regulatory Compliance – Aligns your product with the latest Egyptian Drug Authority requirements.
Enhanced Product Credibility – Boosts confidence among hospitals, clinics, and healthcare professionals.
Supports CE Marked Devices – Devices with CE certification often receive faster approval under EDA’s review system.
Facilitates International Expansion – EDA registration strengthens your brand’s global recognition and market reputation.
For Class II and III medical devices, CE certification is highly recommended — and often a prerequisite for EDA approval.
Steps in the EDA Registration Process
The EDA Registration process in Egypt involves a structured regulatory pathway designed to ensure product safety and efficacy. Operon Strategist simplifies every stage for you.
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.
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Documents Required for EDA Registration
A well-prepared technical file ensures smoother and faster approval.
Here’s what you’ll need for a compliant medical device registration in Egypt:
Valid CE Certificate (highly preferred)
Device Description and Intended Use
Risk Management Report (ISO 14971 compliant)
Clinical Evaluation Report (CER)
Labeling and Instructions for Use (IFU)
Manufacturer’s Details and QMS Certificate (ISO 13485)
Manufacturing Site Details and process flow
Performance Evaluation Data for IVDs
Refer to the EDA Dossier Submission Guidelines for the complete documentation format and submission checklist.
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 in Egypt is mandatory for the following entities:
Manufacturers of Class I, II, or III medical devices
IVD manufacturers and diagnostic reagent producers
Importers and distributors of medical devices or software-based medical systems
Authorized representatives of foreign manufacturers seeking entry into the Egyptian market
Whether you manufacture low-risk Class I devices or high-risk Class III implants, obtaining EDA approval is a legal prerequisite for Egypt medical device registration.
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How Can Operon Strategist Help in EDA Registration?
Operon Strategist is a trusted medical device regulatory consulting firm that specializes in guiding companies through the EDA registration process in Egypt.Our experienced consultants ensure complete compliance with Egyptian regulatory requirements while minimizing approval timelines.
Our End-to-End Regulatory Services Include:
Partner with Operon Strategist to streamline your Egypt medical device registration process and bring your innovative healthcare products to the Egyptian market faster.
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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.
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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.