How do you register a medical device with Egypt's EDA?
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To sell a medical device in Egypt you need approval from the Egyptian Drug Authority (EDA), filed online on the MeDevice portal by a locally licensed applicant — a foreign manufacturer cannot apply directly. Review takes 4–9 months depending on class and a device registration is valid 10 years (US Commercial Service); every shipment also needs an EDA import approval, which EDA answers within 2 working days. Sterile devices cannot be released until registered, and products from non-reference countries such as China, India and Turkey need legalised certificates and may be sampled or sent to a scientific committee.
What are the key EDA facts for device registration?
| Fact | Value | Source | As of |
|---|---|---|---|
| Legal basis | EDA was created by Law 151 of 2019; its executive regulations and fee categories are in Prime Minister's Decree 777 of 2020 | edaegypt.gov.eg | |
| Where you file | Online on the MeDevice portal (medevice.edaegypt.gov.eg), run by EDA's Central Administration of Medical Devices | edaegypt.gov.eg | |
| Who may apply | An importing company, a local facility or a scientific office — not the foreign manufacturer itself | edaegypt.gov.eg | |
| Review time | 4–9 months, depending on device class | trade.gov | |
| Validity (devices) | 10 years | trade.gov | |
| Validity (IVDs) | 5-year marketing licence, renewed in the last 6 months | edaegypt.gov.eg | |
| Import approval | Needed for every shipment; EDA replies within 2 working days; valid 1 year for the whole shipment; cannot be split or transferred; goods must not ship before it is issued | edaegypt.gov.eg | |
| Certificates from reference countries | No Chamber of Commerce or embassy legalisation if EDA can verify them with the issuer; if the issuer does not confirm within 3 months, the file is shelved until they are legalised | edaegypt.gov.eg | |
| Quality certificates | Must be valid for at least 3 months from the date the file is submitted | edaegypt.gov.eg | |
| Variation study fee | EGP 2,000 per variation case study | edaegypt.gov.eg | |
| Serious-incident reporting | Serious public health threat: 2 calendar days. Death or serious deterioration: 10 days. Other serious incidents: 15 days | edaegypt.gov.eg | |
| Search demand we measured | 'EDA Egypt' 2,400 searches a month and 'Egyptian Drug Authority' 1,000 a month, worldwide (Google Keyword Planner, UltraTeb measurement) | ads.google.com |
Consultants report that files needing legalisation, sampling or committee review often take longer than the official range. Last verified 2026-09-25.
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Which documents does EDA ask for, by class?
| Class (EU scheme) | Conformity documents | Also required | Release before registration? |
|---|---|---|---|
| Class I, non-sterile | Declaration of Conformity (DoC) or free sale certificate (FSC) | ISO 13485:2016; legalised distribution contract | Possible on the importer's licence with DoC/FSC or the file acceptance number where registration is required — confirm per product |
| Class I, sterile | DoC + FSC | ISO 13485:2016; legalised distribution contract | No — not released until the registration notification |
| Class IIa | DoC + FSC + CE certificate | ISO 13485:2016; technical file | Sterile: no. Non-sterile: per the import guideline |
| Class IIb and III | DoC + FSC + CE certificate | ISO 13485:2016; technical file; scientific committee review for non-reference origins | Sterile: no. Non-reference origins: committee first |
| US route (any class) | FDA Certificate to Foreign Government + classification letter (510(k)/PMA verified) | ISO 13485:2016 or equivalent QMS evidence | Same release rules as above |
What are the steps to register a device?
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Confirm the route
Device or IVD? Which class? Sterile or not? Is the manufacturer in an EDA reference country? These four answers decide documents, testing and time.
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Sign and legalise the agreement
EDA asks for the distribution or agency contract with the supplier, notarised and authenticated by the Chamber of Commerce and the Egyptian embassy, plus a factory letter if the supplier is not the maker.
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List the manufacturer on the importer's EDA licence
The foreign supplier and manufacturer are added by name to the importer's EDA register based on a relationship letter.
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Collect and check the certificates
ISO 13485:2016, DoC, FSC, CE or FDA evidence and the technical file. Non-reference-country certificates are legalised.
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File on MeDevice
The file receives an acceptance number once the basic documents are complete.
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EDA review
4–9 months by class; sampling or a scientific committee where the rules require it.
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Registration, then every shipment
After the registration notification, each shipment needs an import approval before it ships, an ACID number for customs, and a release inspection in the presence of an EDA inspector.
Which rules slow a file down most often?
- Sterile devices of every class are not released until the registration notification is issued.
- Imported non-sterile medical gloves must be powder-free, show the brand and importer on the certificates, and are sampled every year for testing at Ain Shams University.
- Non-sterile surgical instruments and orthopaedic implants from non-reference countries: the first shipment is sampled and held until the Ain Shams Faculty of Engineering report is issued (valid 1 year).
- Class IIb and III devices from non-reference countries go to a specialised scientific committee (sample and a list of hospitals already supplied).
- Devices used by the oral or nasal route can be imported only after registration.
- Used or demonstration equipment needs a committee decision.
- Changing a registered device's trade name cancels the registration and needs a new one.
- Medical devices may not be advertised in any media without EDA approval.
Who can register my device in Egypt?
Only a locally licensed applicant: an importing company, a local facility or a scientific office (EDA variations guideline). The US Commercial Service calls this local representative the Egyptian Registration Holder (trade.gov). Choosing a distributor in Egypt is therefore also choosing who files and maintains your registration — read the agreement terms on this before you sign.
Can a registration be moved to another company?
EDA's variations guideline allows a change of the applicant's name, not a transfer to a different company. EDA's 2025 import guideline does give a new importer a path: with a notarised contract with the foreign company, a letter from the supplier ending the old relationship and the acceptance number of a new registration file, the new importer can obtain import approvals and has one year from file acceptance to release goods (EDA import guideline). Your commercial agreement still governs costs and notice.
What does EDA registration cost?
Official fees follow the categories in Prime Minister's Decree 777 of 2020; the import-approval fee is charged by invoice-value category, and a variation case study costs EGP 2,000. On top come legalisation, translation and any sample testing. With UltraTeb Market Access these registration costs are funded by us, not paid upfront by you.
“Start the EDA file before you book the freight. For a sterile product, the registration — not the ship — decides when your goods can leave the port.” — Mohamed Dabees, founder, UltraTeb
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.
How does UltraTeb Market Access handle registration for you?
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Route check in the free market study
We confirm class, sterile status, reference-country status and the documents your product needs.
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Gap check and legalisation guidance
We tell you exactly which certificates to send and which need legalisation, before anything is filed.
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Filing and follow-up
We prepare the file, submit it on MeDevice and answer EDA's queries.
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Import approvals every shipment
We obtain the import approval before your goods ship, and an annual import plan once registered.
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Importer duties after launch
Lot-level traceability, EDA vigilance reporting and the advertising approvals needed before any product promotion.
Frequently asked questions
How long does EDA registration take?
The US Commercial Service reports 4–9 months depending on class (trade.gov). Files that need legalisation, sample testing or a scientific committee often take longer.
How long is an EDA registration valid?
10 years for medical devices; 5 years for an IVD marketing licence, renewed in the last 6 months (EDA IVD rules).
Can a foreign manufacturer register directly with EDA?
No. The applicant must be an Egyptian importing company, local facility or scientific office.
Do I need a registration for non-sterile Class I products?
EDA's 2025 import guideline lets non-sterile devices be imported with a DoC or free sale certificate and, where the product is subject to registration, the file acceptance number. Sources disagree on whether every non-sterile Class I item now needs a full file, so we confirm it per product in the free market study.
Do CE or FDA approvals speed things up?
They are the basis of the file (CE certificate, DoC and FSC, or an FDA Certificate to Foreign Government). Certificates from reference countries need no legalisation when EDA can verify them with the issuer.
Which countries are EDA reference countries?
Mostly the EU and EFTA states, the USA, Canada, Japan, Australia and New Zealand; the UK is listed in the IVD rules and the 2025 variations guideline. China, India, Turkey and Korea are not. See EDA reference countries.
Can I ship before the registration is finished?
Not for sterile devices — they are held until the registration notification. Every shipment also needs an import approval issued before shipping.
Can I change the product name after registration?
Changing a registered device's trade name cancels the registration and requires a new one (EDA variations guideline).
Who pays for registration with UltraTeb Market Access?
We do. Registration work and its costs are funded by UltraTeb; you are paid when your goods sell.
We handle registration end to end — with zero upfront fees.
Send us your product and certificates. We check the EDA route in a free market study, then file, import, store and sell. You're paid when we sell.