How can Turkish manufacturers sell medical devices in Egypt?
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Turkish-made medical devices enter Egypt at 0% customs duty under the Türkiye–Egypt Free Trade Agreement, fully phased in on 1 January 2020, when they travel with an EUR.1, EUR-MED or invoice declaration; without one the MFN rate applies (5% on syringes, 10% on medical gloves), and import VAT is due either way (NAFEZA tariff). But Türkiye is not an EDA reference country, even though its devices carry EU-MDR CE marking: every certificate and the distribution contract are legalised at the Egyptian embassy or consulate (no apostille), Class IIb/III devices go to EDA's scientific committee and the first shipment of non-sterile instruments is tested (EDA import guideline). EDA takes the EU route — DoC, TİTCK free sale certificate, CE certificate from Class IIa and ISO 13485:2016 — and syringes must ship from Türkiye or the maker's main centres. 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 Turkish medical devices entering Egypt?
| Fact | Value | Source | As of |
|---|---|---|---|
| Trade agreement with Egypt | Türkiye–Egypt FTA, signed 27 December 2005, in force 1 March 2007. Egypt cut its duties on Turkish industrial goods in four lists, the last reaching zero on 1 January 2020. Proof of origin: EUR.1, EUR-MED or an invoice declaration (approved exporters) | ticaret.gov.tr | |
| Customs duty (official tariff) | 0% with valid proof of Turkish origin: Türkiye rule ر6607 (100% cut) on syringes 9018.31 (MFN 5%), ultrasound 9018.12 (5%), 9019.20 (5%), bone fixation 9021.10 (2%), medical X-ray 9022.14 (5%), diagnostic reagents 3822.19 (5%) and medical gloves 4015.12 (10%). The FTA does not remove import VAT | 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) | nafeza.gov.eg | |
| EDA reference country | No — absent from the reference lists in GL.CAMD.007 v2, GL.CAMD.003 v3 and GL.CAMD.001; EU-MDR alignment and CE marking do not change that | edaegypt.gov.eg | |
| Legalisation | Required for the TİTCK FSC, CE certificate, ISO 13485, DoC and the contract, by the Chamber of Commerce and the Egyptian Embassy or Consulate. An apostille is not accepted (Egypt is not a party). The exact Turkish step order before the embassy was not confirmed | edaegypt.gov.eg | |
| Extra EDA checks (non-reference origin) | Class IIb/III and new-technology devices go to EDA's scientific committee (a Class IIb device without a reference-country trading certificate also needs a signed list of hospitals already supplied); first-shipment samples of non-sterile surgical and laparoscopic instruments and non-sterile orthopaedic implants are tested, report valid 1 year; gas outlets, ceiling pendants and bed-head units need a reference-country FSC; variations need ISO 10993 studies | edaegypt.gov.eg | |
| Certificate route EDA accepts | Regulator TİTCK. Türkiye applies EU MDR 2017/745 and IVDR 2017/746 through its own regulations (from 26 May 2021 and 26 May 2022): CE marking by EU or Turkish notified bodies, products in the ÜTS tracking system. EDA's EU route applies, legalised | titck.gov.tr | |
| Free sale certificate issuer | TİTCK issues e-certificates — the Free Sale Certificate (Serbest Satış Sertifikası) and the Health & Free Sale Certificate — checkable at verify.titck.gov.tr | verify.titck.gov.tr | |
| Shipping lane and transit | Mersin–Alexandria about 1.5 days by sea, with daily departures across carriers; Gebze (Istanbul area)–Abu Qir about 2 days; no Red Sea exposure. EgyptAir flies Istanbul–Cairo, about 2 hours | fluentcargo.com | |
| Egypt's imports from Türkiye — HS 9018 instruments | US$2.83M in 2025, rank 16 of 66; US$1.93M in 2024, rank 22 | comtradeapi.un.org | 2025 |
| Egypt's imports from Türkiye — HS 9019 respiratory | US$1.53M in 2025, rank 5 of 36, up from US$0.25M (rank 12) in 2024 | comtradeapi.un.org | 2025 |
| Egypt's imports from Türkiye — HS 3005 dressings | US$0.25M in 2025, rank 7 of 18; US$0.23M in 2024, rank 6 | comtradeapi.un.org | 2025 |
| Türkiye's trade desk in Cairo | Office of the Commercial Counsellor, Embassy of Türkiye (Ministry of Trade) — Swiss Tower, 3 Ibn Katheer St., Dokki, Giza; kahire@ticaret.gov.tr. A Commercial Attaché also sits in Alexandria | ticaret.gov.tr |
Transit times come from a schedule aggregator, not carrier schedules. Last verified 2026-09-25.
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Why does a CE-marked Turkish device still need legalisation?
Because EDA's reference list is about the country, not the certificate. Türkiye applies EU MDR and IVDR and its devices carry CE marking (TİTCK), but it is absent from EDA's reference-country lists (EDA import guideline). So the TİTCK free sale certificate, the CE certificate, ISO 13485 and the DoC are legalised by the Chamber of Commerce and the Egyptian Embassy or Consulate, and the non-reference checks apply. TİTCK's e-certificates can be checked online at verify.titck.gov.tr, but EDA's rules do not say an online check replaces legalisation for a non-reference country — so plan to legalise.
What proof of origin gets the 0% duty?
An EUR.1 or EUR-MED movement certificate, or an invoice declaration by an approved exporter, under Protocol III of the agreement (Turkish Ministry of Trade). The goods must originate in Türkiye: a Turkish brand whose product is made in China pays MFN (NAFEZA).
How fast is the Türkiye–Egypt lane?
Sea: Mersin to Alexandria about 1.5 days and Gebze to Abu Qir about 2 days, with no Red Sea transit (Fluent Cargo). Air: Istanbul–Cairo about 2 hours, with freighters on the route. With a lane this short, the registration file, not the voyage, sets your launch date.
Which assumptions trip up Turkish makers in Egypt?
- 'CE-marked means reference country' — it does not; Türkiye is non-reference.
- 'Duty-free means no paperwork' — the FTA removes duty, not EDA registration, legalisation or testing.
- Shipping without an EUR.1, EUR-MED or invoice declaration: the MFN rate then applies.
- Claiming Turkish origin for goods made elsewhere: origin follows manufacture under Protocol III.
- Routing syringes or bone-fixation devices through a third-country trader instead of shipping from Türkiye or the maker's main centres.
Your path from Turkey to an Egyptian hospital
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Apply and get a free market study
Send your product list and certificates. We check demand, price and the EDA route for each product.
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Collect the Turkish documents
The TİTCK free sale certificate, the CE certificate (Class IIa and up), the DoC and ISO 13485:2016.
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Legalise them
Chamber of Commerce, then the Egyptian Embassy or Consulate in Türkiye. We check each document before it goes.
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EDA registration
We file on MeDevice and answer EDA's questions; Class IIb and III files go to the scientific committee first.
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Import approval, shipping and clearance
We obtain the EDA import approval, you ship with an EUR.1, EUR-MED or invoice declaration and upload the documents on CargoX, and we clear customs at 0% duty and pay the VAT — with first-shipment testing where the rules require it.
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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.
“For Turkish makers the ship is quick; the file is the part to start early.” — Mohamed Dabees, founder, UltraTeb
How does UltraTeb Market Access take a Turkish 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 give you the document list, prepare the distribution agreement ready for legalisation, and walk you through the chamber → Egyptian embassy or consulate route, checking each document before it leaves Türkiye.
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EDA filing, handled
We file the registration on MeDevice, prepare the committee file for Class IIb/III, plan first-shipment sampling, 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, check your EUR.1 or invoice declaration so the 0% rate applies, clear customs and pay the 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
Do Turkish medical devices pay customs duty in Egypt?
Not when they originate in Türkiye and travel with an EUR.1, EUR-MED or invoice declaration: Egypt's tariff shows a 100% cut under the FTA on syringes, imaging, implants, reagents and gloves (NAFEZA). Import VAT still applies.
Is Turkey an EDA reference country?
No (EDA import guideline). Certificates are legalised, Class IIb/III devices go to the scientific committee and first shipments of non-sterile instruments are tested.
Does CE marking make a Turkish device 'reference'?
No. Reference status depends on the country on EDA's list, not on the marking. Türkiye applies EU MDR and its devices carry CE marking, but it is not on the list.
Is a Turkish apostille accepted in Egypt?
No. Egypt is not an Apostille party (HCCH); documents are legalised by the Chamber of Commerce and the Egyptian Embassy or Consulate.
How long does shipping from Turkey take?
About 1.5 days Mersin–Alexandria and about 2 days Gebze–Abu Qir by sea (Fluent Cargo); about 2 hours Istanbul–Cairo by air.
Does a Turkish brand made in China get 0% duty?
No. Preference follows where the goods are made: goods made in China pay MFN, whatever the brand.
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 Turkey? 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.