How can US manufacturers sell medical devices in Egypt?
Last verified:
US-made medical devices pay Egypt's MFN duty because the US and Egypt have no trade agreement: 5% on syringes, ultrasound, X-ray and diagnostic reagents, 2% on bone-fixation devices and 10% on medical gloves, plus import VAT (NAFEZA tariff). The US is an EDA reference country with its own written route — an FDA Certificate to Foreign Government plus a classification letter, with the 510(k) or PMA checked online — so the CFG needs no legalisation and no CE certificate is required (EDA import guideline). The distribution contract is still legalised — notary, Secretary of State, State Department, then the Egyptian embassy or consulate (USD 132 per document at the Washington embassy) — because Egypt accepts no apostille (Egyptian Embassy). 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 are the key facts for US medical devices entering Egypt?
| Fact | Value | Source | As of |
|---|---|---|---|
| Trade agreement with Egypt | None. The QIZ protocol (since February 2005) is one-way: it lets goods from Egyptian qualifying zones enter the US duty-free and gives US-made goods no preference in Egypt | trade.gov | |
| Customs duty (official tariff) | MFN on US-origin goods: syringes 9018.31 5% + 14% VAT; ultrasound 9018.12 5% + 14%; medical X-ray 9022.14 5% + 14%; heart-lung sets 9019.20.00.10 5% + 14%; bone-fixation plates and screws 9021.10.00.10 2% + 0% VAT; diagnostic reagents 3822.19 5%; medical gloves 4015.12 10% + 14%. Every line requires EDA approval to import (rule ق4120) | nafeza.gov.eg | |
| Direct-shipment rule | Syringes (9018.31) and bone-fixation devices (9021.10.00.10) imported for trading must be shipped from the country of origin or from the producer's main centres (NAFEZA rule ق4122). A US brand made in China, Mexico or Malaysia pays MFN; one made in an EU or Swiss plant can claim EU/EFTA preference | nafeza.gov.eg | |
| EDA reference country | Yes — 'United States of America' is in the reference list of GL.CAMD.007 v2, and 'USA' in the IVD rules (GL.CAMD.001) | edaegypt.gov.eg | |
| Legalisation | FDA CFG: none — EDA verifies CFGs online, and FDA's FURLS Export Certificate Validator authenticates them. Contract and factory letter: always — notary → Secretary of State → US Department of State → the Egyptian embassy or consulate covering that state (USD 132 per document, 5 business days at Washington). Apostille not accepted | egyptembassy.net | |
| Extra EDA checks | None of the non-reference checks: no origin-driven committee review, no first-shipment sampling of instruments or implants, no reference-FSC rule. Every-origin checks remain: non-sterile gloves powder-free and sampled yearly, the first three IVD batches analysed, sterile devices held until registration | edaegypt.gov.eg | |
| Certificate route EDA accepts | A written US route: FDA Certificate to Foreign Government plus a declaration of the US classification, with the 510(k) or PMA checked online; no CE certificate needed. Home regime: FDA Class I general controls, Class II usually 510(k), Class III PMA; De Novo also recognised | edaegypt.gov.eg | |
| Free sale certificate issuer | FDA CDRH — the Certificate to Foreign Government, requested through CECATS. For registered, listed, legally marketed devices made under 21 CFR 820. Anyone can check it in the FURLS Export Certificate Validator. A Certificate of Exportability (device not legal for US sale) is not a free sale certificate | fda.gov | |
| Shipping lane and transit | New York–Abu Qir (Alexandria area) about 34 days by sea, departures every 1–2 weeks, no Red Sea dependence. EgyptAir flies nonstop to Cairo from Chicago, Los Angeles, Newark, New York JFK and Washington Dulles | fluentcargo.com | |
| Egypt's imports from the US — HS 3822 reagents | US$42.01M in 2025, rank 1 of 79; US$44.75M in 2024, rank 1 | comtradeapi.un.org | 2025 |
| Egypt's imports from the US — HS 9021 implants | US$42.69M in 2025, rank 1 of 53; US$40.56M in 2024, rank 1 | comtradeapi.un.org | 2025 |
| Egypt's imports from the US — HS 9018 instruments | US$46.0M in 2025, rank 3 of 66; US$45.96M in 2024, rank 2 | comtradeapi.un.org | 2025 |
| Egypt's imports from the US — HS 9027 lab instruments | US$14.96M in 2025, rank 1 of 62; US$15.45M in 2024, rank 1 | comtradeapi.un.org | 2025 |
| The US trade desk in Cairo | U.S. Commercial Service Egypt, U.S. Embassy Cairo, 8 Kamal El Din Salah Street, Garden City; healthcare is a priority sector | trade.gov |
Transit time comes from a schedule aggregator; Gulf and West Coast origins differ. Last verified 2026-09-25.
Last verified:
What does EDA's US route need?
An FDA Certificate to Foreign Government and a letter declaring the device's US classification, with the 510(k) or PMA checked online by EDA; a CE certificate is not needed (EDA import guideline). FDA's CDRH issues the CFG through CECATS for devices that are registered, listed, legally marketed in the US and made under 21 CFR 820, and anyone can check it in the FURLS Export Certificate Validator (FDA). Two traps: a device not legal for US sale gets a Certificate of Exportability, which is not a free sale certificate and will not satisfy EDA; and a 510(k)-exempt device cannot show a 510(k), so the declaration letter must state the exemption.
How is the distribution agreement legalised in the US?
A notary public signs with a dry seal, then the Secretary of State of the notary's state certifies, then the US Department of State, then the Egyptian embassy or the consulate that covers that state — USD 132 per document and 5 business days at the Washington embassy, which serves only DE, FL, GA, MD, NC, SC, VA, DC and WV (Egyptian Embassy). The US apostille does not help, because Egypt is not a party (HCCH).
Does a US brand made abroad pay the same duty?
Duty follows where the goods are made. A US brand made in China, Mexico or Malaysia pays MFN; one made in an EU or Swiss plant can claim EU or EFTA preference, 0%, with valid proof of origin. And syringes and bone-fixation devices imported for trading must ship from the country of origin or the producer's main centres (NAFEZA).
Where are US products strong in Egypt?
The US was Egypt's largest source in 2025 of diagnostic reagents (US$42.01M), orthopaedic appliances and implants (US$42.69M) and lab analysis instruments (US$14.96M), and 3rd of HS 9018 instruments (UN Comtrade).
What needs care for US products?
- Budget MFN duty: reference status does not remove it.
- Use a CFG, not a Certificate of Exportability.
- State a 510(k) exemption in the declaration letter where it applies.
- Send agreement documents to the Egyptian embassy or consulate that covers your state.
- Every-origin checks remain: powder-free gloves sampled yearly, the first three IVD batches analysed, sterile devices held until registration.
Your path from the USA to an Egyptian hospital
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Apply and get a free market study
Send your product list and FDA status. We check demand, price and the EDA route for each product.
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Collect the US documents
The FDA Certificate to Foreign Government from CECATS and a letter declaring the US classification, with the 510(k), PMA, De Novo or exemption stated.
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Legalise the agreement
Notary, Secretary of State, US Department of State, then the Egyptian embassy or consulate for your state. We check the agreement before it goes.
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EDA registration
We file on EDA's MeDevice portal and answer EDA's questions; EDA verifies your CFG online.
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Import approval, shipping and clearance
We obtain the EDA import approval before you ship, you upload the documents on CargoX, and we clear customs and pay the duty and VAT.
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Sold to Egyptian hospitals
We store, market and sell to private hospitals, labs and clinics and in UPA tenders. You're paid when it sells.
“The paperwork is the easy half for an American maker. The half that decides success is who sells your product every day.” — Mohamed Dabees, founder, UltraTeb
How does UltraTeb Market Access take a US product to market in Egypt?
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Free market study and EDA route
We check demand, pricing and the EDA route for your product — device or IVD, class, sterile or not — before you commit to anything.
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Documents prepared, legalisation mapped
We confirm the CFG and classification letter EDA needs, prepare the distribution agreement ready for legalisation, and walk you through the notary → Secretary of State → State Department → Egyptian embassy chain, checking each document before it is sent.
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EDA filing, handled
We file the registration on MeDevice on the US route, answer EDA's questions and obtain an import approval before every shipment.
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Import, customs, duty and VAT
We are the Egyptian importer: we obtain the ACID number, receive your CargoX documents, clear customs and pay the duty and import VAT.
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Stored, marketed and sold
We warehouse your stock, list it on shop.ultrateb.com in Arabic and English, obtain the EDA advertising approval before any promotion, and sell to private hospitals, labs and clinics and through UPA tenders where your product fits.
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Paid when it sells
You see your stock and sales, and you're paid when your goods sell.
Frequently asked questions
Is the USA an EDA reference country?
Yes (EDA import guideline), and EDA writes a specific US certificate route based on the FDA Certificate to Foreign Government.
Do US medical devices pay customs duty in Egypt?
Yes, MFN duty, because there is no US–Egypt FTA: 5% on syringes, ultrasound, X-ray and reagents, 2% on bone-fixation devices and 10% on medical gloves, plus import VAT (NAFEZA).
Does my FDA CFG need legalisation?
No. EDA verifies FDA CFGs online, and FDA's FURLS Export Certificate Validator authenticates them (FDA). The distribution agreement still needs legalisation.
Do I need a CE certificate for Egypt?
Not on the US route: the CFG and a classification letter, with the 510(k) or PMA checked online, take its place (EDA import guideline).
Is a US apostille accepted in Egypt?
No. Egypt is not an Apostille party (HCCH); the Egyptian embassy or consulate for your state legalises after the State Department.
Does the QIZ agreement help US exporters?
No. QIZ lets goods from Egyptian qualifying zones enter the US duty-free; it gives US goods no preference in Egypt.
Who pays for registration and import with UltraTeb Market Access?
We do. Registration, import, customs duty and import VAT are funded by UltraTeb, and you're paid when your goods sell. Your own costs stay on your side: producing your documents and, where EDA requires it, legalising them in your country.
Selling from the USA? We handle the Egyptian side.
Zero upfront fees. We check your EDA route and documents in a free market study, then register, import, store, market and sell. You're paid when we sell.