EDA registration, handled end to end
We handle your Egyptian Drug Authority (EDA) registration end to end — classification, dossier, filing, EDA questions, samples and renewals — and we fund it: there is no upfront fee. A realistic planning range for a new device registration is 6–12 months (the US Commercial Service reports a 4–9-month review); sterile devices cannot be released until registered, while a new IVD may be sold for 6 months while its file is pending.
UltraTeb Market Access is a zero-upfront-fee route into Egypt's medical market: UltraTeb registers, imports, markets, stores and sells your product, shares the risk, and pays you when it sells.
What do we do for your registration?
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Classification and route
We classify your product under EDA's rules (Class I, IIa, IIb, III; IVD categories) and choose the route: listing, registration, or IVD registration with the 6-month selling window.
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Document checklist
You get the exact list for your product and origin, including which documents must be legalised.
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Dossier
We build the file, check labels and instructions for use for EDA's Arabic and English requirements, and prepare the forms.
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Filing and follow-up
We file on EDA's MeDevice portal, answer EDA's questions, deliver samples when asked, and follow the file to approval.
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Import approvals
Once registered or accepted, we obtain the import approval for each shipment.
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Changes and renewals
We file variations when your product changes and renew registrations before they expire.
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Vigilance
We handle EDA's vigilance commitments with you, including incident and recall reporting.
What are the key registration facts?
| Fact | Value | Source | As of |
|---|---|---|---|
| Regulator | Egyptian Drug Authority (EDA), Central Administration of Medical Devices; filings on the MeDevice portal | edaegypt.gov.eg | |
| Who can file | An importing company, a local facility or a scientific office in Egypt — not the foreign manufacturer directly | edaegypt.gov.eg | |
| Classification | EU scheme: Class I, IIa, IIb, III; IVDs by risk category | edaegypt.gov.eg | |
| New registration, normal track | 6–12 months (consultant planning range) | meddeviceguide.com | 2026 |
| Validity | Devices 10 years; IVDs 5 years | trade.gov | |
| Sterile devices | Not released until the registration notification is issued | edaegypt.gov.eg | |
| New IVDs | May be sold for 6 months from the first import approval while the file is pending; the first 3 batches after licensing are tested by EDA | edaegypt.gov.eg | |
| Certificates from non-reference countries (e.g. China, India, Turkey, Korea) | Must be legalised; Class IIb and III go to EDA scientific committees | edaegypt.gov.eg | |
| Quality certificates | Must be valid for at least 3 months from the file submission date | edaegypt.gov.eg | |
| Devices on the EDA register | 3,959 (June 2026); 1,007 approvals in 2025 against 723 in 2024 | meddeviceguide.com | |
| Worldwide searches for 'EDA Egypt' | 2,400 per month ('medical device registration': 720) | ads.google.com |
The search figures are UltraTeb's own Keyword Planner measurement on 2026-09-25.
Last verified:
Which certificates does EDA ask for?
| Device class (EU route) | Certificates |
|---|---|
| Class I, non-sterile | Declaration of Conformity (DoC) or Free Sale Certificate (FSC); ISO 13485:2016 |
| Class I, sterile | DoC and FSC; ISO 13485:2016 |
| Class IIa | DoC, FSC and CE certificate; ISO 13485:2016 |
| Class IIb and III | DoC, FSC and CE certificate; ISO 13485:2016; scientific committee approval where it applies |
| US route (any class) | FDA Certificate to Foreign Government (CFG) and classification letter, with 510(k) or PMA verification |
Is your country an EDA reference country?
EDA's reference countries are Australia, Canada, Japan, New Zealand, Switzerland, the USA, Iceland, Liechtenstein, Norway, the EU member states (EDA import guideline) and the UK (EDA variations guideline, Sept 2025). China, India, Turkey, Korea, Pakistan, Malaysia and Brazil are not. Products from non-reference countries are welcome — they need legalised certificates and sometimes sample testing, so we plan more time.
Are there traps for specific products?
- Gloves: imported non-sterile medical gloves must be powder-free and are sampled every year for laboratory analysis.
- Instruments and orthopaedic implants from non-reference countries: the first shipment is held until a laboratory analysis is issued.
- Oral and nasal route devices: imported only after the registration notification.
Source for all three: EDA import-approval guideline.
Who files the registration?
Egyptian rules require a locally licensed company to file; a foreign manufacturer cannot hold an Egyptian registration directly. We prepare, file and manage it as your partner in Egypt. How the registration is handled if the partnership ends is set out in the distribution agreement, before your first shipment.
“You should not need an office in Cairo to sell in Egypt. We handle the registration end to end, and you can see where it stands at every step.” — Mohamed Dabees, Founder, UltraTeb
Frequently asked questions
How long does EDA registration take?
Plan for 6–12 months for a new device on the normal track; the US Commercial Service reports a 4–9-month review. Files that need legalised documents, samples or a scientific committee can take longer. We give you the expected timeline for your product in the market study.
Can I sell before registration is complete?
Sometimes. A new IVD may be sold for 6 months from its first import approval while the file is pending. Many non-sterile Class I items can be imported with a file acceptance number plus a DoC or FSC. Sterile devices cannot be released until registered.
Do I pay for registration?
No upfront fee. Registration is funded by UltraTeb as part of the programme. Your own costs stay on your side: producing your documents and, where required, legalising them in your country.
Do labels need Arabic?
Consultant sources report that EDA requires labels and instructions in Arabic and English for devices, and EDA's IVD rules set what the outer pack must show, including the Egyptian registration number. We check your labelling during the study and tell you what to change.
Do my ISO 13485 and CE certificates need to be valid for a minimum time?
Yes. EDA asks for quality certificates valid for at least 3 months from the submission date.
What happens to the registration if we stop working together?
It is covered in the distribution agreement, which we agree with you in writing before your first shipment.
Let us handle your EDA registration
Zero upfront fees. We handle registration, import, customs, duties, warehousing and selling. You're paid when we sell.