This guide is provided for general information only. Regulatory requirements change periodically and should be independently verified before submitting an application. This guide does not constitute regulatory advice. Contact Lepaz Africa for advice tailored to your specific device and situation.
At a Glance
| Topic |
Detail |
| Regulatory authority |
Egyptian Drug Authority (EDA) — Central Administration of Medical Devices |
| Classification system |
EU MDR-aligned: Class I, IIa, IIb, III (devices); Class A, B, C, D (IVDs) |
| Review timeline |
Standard track: 6–8 months; fast-track pathway available |
| Certificate validity |
10 years for medical devices (longest in the Lepaz Africa network); 5 years for IVDs |
| Local representative |
Egyptian Registration Holder (ERH) mandatory — legally owns the registration |
| Submission portal |
MeDevice portal (launched July 2021) |
| Registration fees |
Standard track: USD 450 per device; fast-track: USD 1,280 per device (subject to periodic revision — verify before submission) |
| CE Mark reliance |
Primary reference standard; strongly recommended for Class II and III devices |
| Licence transfer |
Not permitted — registration is owned by the ERH; new registration required if ERH changes |
| February 2026 update |
EDA announced procedural simplifications reducing administrative friction for documentation requirements |
The Egyptian Registration Holder (ERH) Model
This is the most important aspect of Egypt market access to understand before beginning the process. All foreign manufacturers without a direct Egyptian presence must appoint an Egyptian Registration Holder (ERH). The ERH can be:
- A commercial distributor holding the necessary EDA licences, or
- An EDA-licensed Scientific Office
The ERH legally owns the registration. This has significant commercial implications: if you change ERH, the registration cannot be transferred — it must be re-registered. Choosing the right ERH is therefore the single most critical decision in the Egypt registration process.
Lepaz Africa: We work with a very experienced ERH based in Cairo on behalf of our clients. Partner selection is managed as part of our service.
Classification
Egypt uses EU MDR-aligned classification for medical devices:
- Class I: Low risk — non-sterile, non-measuring devices are exempt from registration (listing required)
- Class IIa: Medium risk
- Class IIb: Medium-to-high risk
- Class III: High risk
IVDs are classified as Class A (lowest) through D (highest), following EU IVDD principles. Your existing CE classification is the starting point for Egypt classification.
Registration Pathways
Standard Track
Review timeline: 6–8 months. Applicable to all device classes. Submission fee: USD 450 per device. The standard track requires a complete technical dossier submitted through the MeDevice portal by the ERH.
Fast-Track
A fast-track pathway is available for eligible devices. Submission fee: USD 1,280 per device. Fast-track applications are prioritised for review. Confirm eligibility criteria with your ERH or Lepaz Africa before committing to this route.
Documentation Requirements
Documentation is submitted by the ERH through the MeDevice portal. Key documents typically required include:
- Completed EDA application form
- Valid CE certificate (Class II and III — CE Mark is strongly recommended and often a prerequisite)
- ISO 13485 certificate
- Technical dossier — device description, intended use, specifications, manufacturing details
- Clinical evaluation report or summary of clinical evidence
- Labelling in Arabic and English — instructions for use must include Arabic
- Certificate of Free Sale from the country of manufacture
- ERH appointment documentation — confirming the relationship between manufacturer and ERH
February 2026 update: EDA announced procedural simplifications on 12 February 2026, reducing administrative friction in documentation requirements. Previously, letters documenting relationships between corporate branches required prior legalisation; this requirement has been relaxed. Check with your ERH for the current documentation requirements following these updates.
Submission Process
All submissions are made through the MeDevice portal, which was launched in July 2021 to replace paper-based submissions. The ERH manages the submission. Once submitted, EDA will notify the ERH within approximately 20 days whether the application has been accepted and the formal review has commenced.
Labelling Requirements
Labelling must be in Arabic and English. Instructions for use must include Arabic. Plan for translated labelling materials well in advance — translation and review by the ERH should be built into the project timeline.
Certificate and Renewal
Medical device certificates are valid for 10 years — the longest validity period of any market in the Lepaz Africa partner network, and a significant commercial advantage when factoring in renewal costs. IVD certificates are valid for 5 years. Licence transfer is not possible; a new registration is required if the ERH changes.
Market Context
Egypt’s medical device market was valued at approximately USD 4.24 billion in 2023. The market is heavily import-dependent, with strong demand across both public and private healthcare sectors. Egypt has been investing substantially in healthcare infrastructure expansion and is increasing its engagement with international regulatory standards, as evidenced by its IMDRF affiliate membership and Vice Chairmanship of the African Medical Devices Forum.
Sources & References
Need help with your registration in this market?
Lepaz Africa has a vetted, active partner in Egypt ready to begin submissions on your behalf. Get in touch to discuss your device and timeline.
Contact us → info@lepazafrica.com
