Who can register my medical device in Egypt?
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Only a company licensed in Egypt can file: EDA accepts an importing company, a local facility or a scientific office as the applicant, never the foreign manufacturer itself (EDA). The manufacturer supplies the technical documents — for example a Declaration of Conformity, a free sale certificate, CE or FDA evidence and an ISO 13485 certificate valid for at least 3 months from submission — plus a distribution contract authenticated by the Chamber of Commerce and the Egyptian embassy (EDA). The review takes 4–9 months by class, and a device registration is valid for 10 years (US Commercial Service).
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 EDA's rules say about the applicant?
| Fact | Value | Source | As of |
|---|---|---|---|
| Who may apply | An importing company, a local facility or a scientific office — not the foreign manufacturer | edaegypt.gov.eg | |
| Where the file goes | Online on EDA's MeDevice portal, run by the Central Administration of Medical Devices | edaegypt.gov.eg | |
| Importer licence | EDA keeps a register of medical device importers; each foreign supplier and manufacturer is added to the importer's licence by name, based on a relationship letter | edaegypt.gov.eg | |
| Contract with the supplier | The distribution or agency contract, notarised and authenticated by the Chamber of Commerce and the Egyptian embassy | edaegypt.gov.eg | |
| Certificates by class (EU route) | Class I non-sterile: DoC or free sale certificate · Class I sterile: DoC + FSC · Class IIa: DoC + FSC + CE · Class IIb/III: DoC + FSC + CE, plus scientific committee approval where applicable; ISO 13485 | edaegypt.gov.eg | |
| Quality certificates | Must be valid for at least 3 months from the date the file is submitted | edaegypt.gov.eg | |
| Legalisation | Reference-country certificates need none if EDA can verify them with the issuer (FDA certificates are verified online); other certificates must be legalised | edaegypt.gov.eg | |
| Scientific offices | Regulated by EDA Chairman's Decision 315 of 2021; only scientific offices may import promotional samples | edaegypt.gov.eg | |
| Scientific offices of foreign companies | A foreign company may open a scientific or technical office only if it has a registered commercial agent (Law 120 of 1982, Art. 7) | goeic.gov.eg | 1982 |
| Changing partner later | No transfer between companies; the new importer files a new registration and, with a notarised contract and the supplier's end-of-relationship letter, gets 1 year from file acceptance to release goods | edaegypt.gov.eg | |
| Validity | Devices 10 years; IVDs 5 years | trade.gov | |
| Devices on the EDA register | 3,959 (June 2026); 1,007 approvals in 2025 against 723 in 2024 | meddeviceguide.com |
EDA guidelines EDREX:GL.CAMD.003 v3 and GL.CAMD.007 v2, both dated 1 September 2025.
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Which kind of applicant fits which situation?
| Applicant | What it is | Imports and sells? | Worth knowing |
|---|---|---|---|
| Importing company | An Egyptian company on the Importers Register with an EDA importer licence | Yes — it imports, clears and sells | Your company is added to its EDA licence by relationship letter |
| Scientific office | An office licensed under EDA Decision 315 of 2021 | Works with a licensed importer for commercial imports | A foreign company may open one only if it has a registered commercial agent (Law 120 of 1982) |
| Your own subsidiary | An Egyptian company you own, registered as an importer | Yes | Foreign-majority importers can register for up to 10 years in total under Law 173 of 2023 |
| Local facility | An Egyptian manufacturing site | For its own products | Relevant if you manufacture or finish products in Egypt |
Can a foreign manufacturer register directly with EDA?
No. EDA defines the applicant as an importing company, a local facility or a scientific office in Egypt (EDA). The manufacturer's job is to supply complete, consistent documents; the Egyptian applicant files them on the MeDevice portal and answers EDA's questions.
Which documents does the manufacturer have to provide?
The Declaration of Conformity, a free sale certificate, CE or FDA evidence depending on the route and class, and an ISO 13485 certificate — all valid for at least 3 months from submission — plus the legalised distribution contract and, if the supplier is not the factory, the factory's authorisation letter. For IVDs, the product must already be sold in its country of origin or an EDA reference country, and the first three batches imported after licensing are tested before release (EDA IVD rules). Our EDA document checklist lists them by class.
Who holds the registration, and what if we part ways?
The registration sits with the Egyptian applicant that filed it. EDA's variations guideline has no procedure for transferring a registration from one company to another. If you later appoint a new partner, it files a new registration; with a notarised contract and your letter ending the previous relationship, it can obtain import approvals and has 1 year from file acceptance to release goods (EDA). With UltraTeb Market Access we handle registration end to end, and your agreement states in writing how the registration is held and what happens to it at the end.
How long does it take, and what adds time?
The US Commercial Service reports a 4–9-month review by class (trade.gov); plan for 6–12 months for a new device on the normal track. Legalising certificates from outside EDA's reference countries, sample testing and scientific-committee review for Class IIb and III from non-reference countries all add time. Mismatched names, codes or trade names between the certificates, the invoice and the label are the most avoidable delay.
“With EDA, consistency wins: the invoice, the certificates and the label must tell exactly the same story.” — Mohamed Dabees, founder, UltraTeb
How does UltraTeb Market Access handle registration?
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Route check first
The free market study confirms your product's class, route and documents.
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File end to end
We prepare, file and follow the registration on MeDevice and answer EDA's questions.
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Import approvals
We obtain the import approval for every shipment before it leaves your factory.
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Then we sell
No hand-off between a registration holder and a seller: we import, store, market and sell.
Frequently asked questions
Can a foreign company hold an EDA registration?
No. The applicant must be a company licensed in Egypt — an importing company, a local facility or a scientific office (EDA).
Do I need to legalise my certificates?
Not if they come from an EDA reference country and EDA can verify them with the issuer. Certificates from other countries, such as China, India, Turkey or Korea, must be legalised by the Chamber of Commerce and the Egyptian consulate.
Can my registration be moved to another partner later?
EDA has no procedure to transfer a registration between companies. A new partner files a new registration and, with a notarised contract and your end-of-relationship letter, gets 1 year from file acceptance to release goods.
Who registers my product with UltraTeb Market Access?
We handle the registration end to end, funded by UltraTeb. Your agreement states in writing how the registration is held and what happens to it at the end.
How long is a registration valid?
Devices 10 years; IVD marketing licences 5 years, renewed in the last 6 months of validity.
We handle your EDA registration end to end
Tell us about your product in 2 minutes. The market study and pricing are free; then we handle registration, import, duties, warehousing and selling. You're paid when we sell.