Partner requirements: what we accept and what we decline
Last verified:
We accept medical devices, sterile and non-sterile consumables and laboratory/IVD products that can be registered in Egypt and sold at a competitive price — and we decline many products, including all pharmaceuticals. You need recognised certificates (CE or FDA evidence, ISO 13485:2016, a Free Sale Certificate) that are valid for at least 3 months from the file submission date, a long shelf life on arrival, labelling that can meet Egypt's Arabic and English requirements, and willingness to start with a small pilot.
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.
Not every product is accepted. We only take products we believe we can register and sell. If the answer is no, we tell you why.
What do we accept?
- Medical devices, Class I to III, including equipment and instruments
- Sterile and non-sterile medical consumables
- Laboratory and in-vitro diagnostic (IVD) reagents, kits, rapid tests and analysers
- Laboratory plastics, glassware and equipment
- Products from any country — reference-country products usually move faster
- Manufacturers, exporters and OEM factories with the manufacturer's written authorisation
What do we decline?
- Pharmaceuticals: medicines, vaccines, serums and blood products
- Products that cannot be registered or listed with EDA
- Used, refurbished or demonstration equipment for resale
- Products without recognised certificates or a quality management system
- Products whose landed price cannot compete in Egypt
- Products that need clinical claims to be sold
Which certificates do you need?
| Certificate | Why EDA asks for it | Notes |
|---|---|---|
| CE certificate and Declaration of Conformity (MDR or IVDR), or FDA evidence (Certificate to Foreign Government, 510(k) or PMA) | Proves the product is approved in a recognised market | Class IIa and above need the CE certificate, not only the DoC |
| ISO 13485:2016 | Proves the manufacturer's quality management system | From an accredited certification body |
| Free Sale Certificate (FSC) | Proves the product is legally sold in its home market | For IVDs: from the country of origin or an EDA reference country |
| Legalisation (Chamber of Commerce and Egyptian embassy or consulate) | Needed for certificates from non-reference countries | Also needed for the distribution agreement and the factory's authorisation letter |
Which EDA rules affect specific products?
| Fact | Value | Source | As of |
|---|---|---|---|
| Quality certificates | Valid for at least 3 months from the file submission date | edaegypt.gov.eg | |
| IVDs | Must already be sold in the country of origin or an EDA reference country; the first 3 batches after licensing are tested by EDA | edaegypt.gov.eg | |
| Non-sterile medical gloves | Must be powder-free, show the brand and the importer on the certificates, and are sampled every year for laboratory analysis | edaegypt.gov.eg | |
| Instruments and orthopaedic implants from non-reference countries | First shipment held until a laboratory analysis report is issued; the report is valid for 1 year | edaegypt.gov.eg | |
| Class IIb and III from non-reference countries | Referred to EDA's specialised scientific committees | edaegypt.gov.eg | |
| Imported devices | Must be new and unused | edaegypt.gov.eg | |
| HS 9619 and 4818 items (e.g. adult diapers, underpads, paper sheets) | The factory must be registered with GOEIC before shipment | goeic.gov.eg | 2016 |
EDA rules as published; last verified 2026-09-25. We confirm the route for your exact product in the market study.
Last verified:
What else makes a product a good fit?
- A long remaining shelf life on arrival — the minimum is agreed per product
- Labels and instructions for use that can be provided in Arabic and English where EDA requires it
- Storage conditions we can meet, including 2–8 °C where needed
- A price that still competes after freight, duty and VAT
- Willingness to start with a small pilot order
- A contact person who answers document questions quickly
Why do we decline products?
Because every product we accept costs us registration, import, duty and VAT before it sells. Saying no early is fairer to you than accepting a product we cannot sell.
Can a 'no' become a 'yes'?
Often. A missing certificate, a different pack size or a different product from your range can change the answer. We tell you what would need to change.
“We say no to products we cannot sell. It protects your time and ours.” — Mohamed Dabees, Founder, UltraTeb
Frequently asked questions
Do you accept pharmaceuticals?
No. We work only with medical devices, medical consumables and laboratory/IVD products.
My product has no CE or FDA approval. Can you still take it?
Possibly. EDA's document lists are built around EU, US and similar approvals. If your product has another regulator's approval, tell us in the form and we will check whether EDA can accept it.
What minimum shelf life do you need?
It is agreed per product. Hospitals and tenders prefer a long remaining shelf life, so the more your goods have on arrival, the better.
Do my labels have to be in Arabic before I apply?
No. We check your labelling during the study and tell you what EDA requires for your product type and what to change before the first shipment.
Can a trading company apply?
Yes, with the manufacturer's written authorisation to supply Egypt. EDA asks for a legalised letter from the factory when the supplier is not the manufacturer (EDA guideline).
How big is the first order?
Small. The pilot quantity is recommended in the market study and agreed with you.
Check your product in 60 seconds
Zero upfront fees. If your product fits, we handle everything — registration, import, customs, duties, warehousing and selling. You're paid when we sell.