What is the Egyptian Drug Authority and what does it control for medical devices?
Last verified:
The Egyptian Drug Authority (EDA) is Egypt's regulator for medicines and medical products, created by Law 151 of 2019 — the same law that created the Unified Procurement Authority (UPA), which buys for public hospitals. For medical devices and IVDs, EDA registers products (review 4–9 months, device registration valid 10 years), issues an import approval for every shipment (reply within 2 working days), inspects goods on release, runs post-market vigilance and must approve any device advertising.
What are the key facts about EDA for device makers?
| Fact | Value | Source | As of |
|---|---|---|---|
| Created by | Law 151 of 2019, which also created the Unified Procurement Authority (UPA) | riad-riad.com | 2019 |
| Device unit and portal | Central Administration of Medical Devices (CAMD); all filings online on MeDevice | edaegypt.gov.eg | |
| Registration review | 4–9 months depending on class; valid 10 years | trade.gov | |
| Import approval | Reply within 2 working days; valid 1 year per whole shipment | edaegypt.gov.eg | |
| Release inspection | The importer pledges not to open a shipment except in the presence of an inspector from EDA's Central Administration for Inspection on Pharmaceutical Institutions | edaegypt.gov.eg | |
| Vigilance | Medical Device Safety Unit; guideline GL.CAP.Care.040 v1 (Nov 2025); serious incidents reported in 2, 10 or 15 calendar days by severity | edaegypt.gov.eg | |
| Scientific offices | Regulated by EDA Chairman's Decision 315 of 2021; only scientific offices may import promotional samples | edaegypt.gov.eg | |
| International standing | EDA cites its WHO Maturity Level 3 status and takes part in African Medical Devices Forum harmonisation work | edaegypt.gov.eg | |
| Search demand we measured | 'Egyptian Drug Authority' 1,000 searches a month; 'EDA Egypt' 2,400 a month, worldwide (Google Keyword Planner, UltraTeb measurement) | ads.google.com |
Last verified 2026-09-25 against EDA's own guidelines where they are public.
Last verified:
Which EDA approval do you need at each step?
| Step | EDA approval | Filed by | Time or validity |
|---|---|---|---|
| Before the first sale | Product registration (devices) or marketing licence (IVDs) | A locally licensed importer, local facility or scientific office | 4–9 months review; 10 years (devices) or 5 years (IVDs) |
| Before each shipment | Import approval, or an annual import plan (1 July – 30 June) for registered devices | The importer | Reply in 2 working days; valid 1 year |
| On arrival | Release inspection | Importer, with an EDA inspector present | Per shipment |
| After launch | Vigilance: incident reports, field safety notices, recalls | Manufacturer, importer and distributor | 2 / 10 / 15 calendar days for serious incidents |
| Before any promotion | Advertising approval | The company promoting the device | Required before any media advertising |
| When something changes | Variation (Do-and-tell or Tell-and-do) | The registration holder | EGP 2,000 case-study fee |
Is EDA the same as UPA?
No. Both were created by Law 151 of 2019, but they do different jobs. EDA regulates: it decides whether a product may be imported and sold. UPA buys: it runs public procurement of medicines and medical supplies for government facilities. Since July 2025 public purchases are tripartite contracts in which the requesting hospital pays the supplier directly (Adsero). See selling to UPA.
Does EDA set the prices of medical devices?
EDA prices medicines — in September 2026 the government moved medicine pricing to an FX band (Enterprise). Our research found no general statutory price control on medical devices and consumables; in practice, public tender estimates act as reference prices.
How do I contact EDA about my product?
Filings are made on the MeDevice portal by the local applicant, not by the foreign manufacturer. In practice your Egyptian partner files, answers EDA's queries and attends inspections.
Can I advertise my device in Egypt?
Only after EDA approves the advertisement: medical devices may not be advertised in any media without it (EDA import guideline).
“With EDA, consistency wins: the invoice, the certificates and the label must tell exactly the same story.” — Mohamed Dabees, founder, UltraTeb
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.
How does UltraTeb Market Access deal with EDA for you?
-
One partner for every EDA step
Registration or IVD licence, import approvals, release inspections and variations.
-
Documents that match
We check that the invoice, certificates and labels agree before anything is filed or shipped.
-
Vigilance as importer
Lot traceability, incident reporting and recall handling under EDA's 2025 vigilance guideline.
-
Advertising approvals
We obtain the required approval before we market your product.
Frequently asked questions
What does the Egyptian Drug Authority regulate?
Medicines and medical products, including medical devices and in vitro diagnostics. Devices are handled by its Central Administration of Medical Devices.
When was EDA created?
By Law 151 of 2019, which also created the Unified Procurement Authority (UPA).
What is MeDevice?
EDA's online portal for medical device and IVD filings: registrations, import approvals and variations.
Can a foreign company file with EDA directly?
No. A locally licensed importer, local facility or scientific office files on its behalf.
How fast does EDA answer an import approval request?
Within 2 working days (accept, reject or suspend), per EDA's 2025 import guideline.
What does EDA do after a product is on the market?
It runs vigilance: manufacturers, importers and distributors must report serious incidents in 2, 10 or 15 calendar days by severity, keep lot traceability and appoint a safety officer (EDA vigilance guideline).
Does EDA approve device advertising?
Yes. Devices may not be advertised in any media without EDA approval.
Does an EDA registration work in other African countries?
No. Each country needs its own registration with its own regulator. See Africa market entry.
We deal with EDA — you focus on making the product.
Zero upfront fees: we register, import, store, market and sell, and you're paid when we sell.