Download the EDA registration document checklist
The checklist lists the documents EDA asks for when an Egyptian applicant registers and imports your product, by class and route: on the EU route, a Declaration of Conformity or free sale certificate for non-sterile Class I, DoC plus free sale certificate for sterile Class I, and DoC, free sale certificate and CE for Class IIa to III, plus an ISO 13485 certificate valid for at least 3 months from submission (EDA). It also covers legalisation, the free sale certificate's content, labels, the legalised distribution contract and the extra rules for IVDs.
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 is inside the checklist?
- Certificates by class on the EU route (DoC, free sale certificate, CE) and on the US route (FDA Certificate to Foreign Government and classification evidence)
- ISO 13485 and the 3-month validity rule
- Legalisation: when reference-country certificates are exempt, and when the Chamber of Commerce and Egyptian consulate are needed
- What the free sale certificate must show: trade name, codes and sizes, legal and actual manufacturer
- The legalised distribution contract, the relationship letter and, where needed, the factory's authorisation letter
- Labels: manufacturer and importer contact details, and for IVDs the outer-pack data and EDA's vigilance QR code
- IVD rules: prior sale in the origin or a reference country, the 6-month selling window and the first three batches tested
- Products that are sampled or go to a scientific committee when they come from non-reference countries
- The vigilance commitment every applicant files
Which EDA rules does the checklist follow?
| Fact | Value | Source | As of |
|---|---|---|---|
| Certificates by class (EU route) | Class I non-sterile: DoC or FSC · Class I sterile: DoC + FSC · IIa: DoC + FSC + CE · IIb/III: DoC + FSC + CE, plus committee approval where applicable | edaegypt.gov.eg | |
| Quality certificates | Valid for at least 3 months from the file submission date | edaegypt.gov.eg | |
| Free sale certificate | Must contain the trade name, codes and sizes, and the legal and actual manufacturer | edaegypt.gov.eg | |
| Legalisation | Not needed for reference-country certificates EDA can verify; unconfirmed after 3 months means the file is shelved until legalised | edaegypt.gov.eg | |
| IVD outer pack | Legal manufacturer, country of origin, expiry date, batch number and Egyptian registration number, plus EDA's vigilance QR code | edaegypt.gov.eg | |
| Labelling contact details | Manufacturer and importer contact details must appear on the labelling | edaegypt.gov.eg |
Based on EDA guidelines current on 25 September 2026. EDA can change requirements; the checklist shows the version date.
Last verified:
Who is this checklist for?
Regulatory and export teams preparing a first file for Egypt, or checking what an Egyptian partner will ask for. For the process around the documents, read the EDA registration guide; to see which route your product takes, use the EDA route finder.
“Print nothing until the registration file is settled. A label that doesn't match the file is the cheapest mistake to avoid and the most expensive to fix.” — Mohamed Dabees, founder, UltraTeb
Frequently asked questions
Is the checklist free?
Yes. Enter your email, company and country and we send you the PDF.
Does it cover IVDs and lab reagents?
Yes: the IVD rules on prior sale, the 6-month selling window, testing of the first three batches and outer-pack labelling are included.
What happens to my details?
They go to the UltraTeb Market Access team so we can send the file and answer your questions. We never sell your data.
We file it for you
Apply in 2 minutes. Zero upfront fees: we handle your EDA registration end to end, then import, duties, warehousing and selling. You're paid when we sell.