EDA market accessResearch EDA registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Egypt medical device resource.
Search official EDA medical device registration records.
Browse official EDA regulations and guidance documents.
Review current EDA application, review, and renewal fees.
Estimate the likely EDA pathway, government fees, dossier preparation time, review timeline, and registration steps.
Follow recent EDA policy, guidance, and compliance updates.
Describe your device and get a preliminary EDA risk class with an explanation and source links.
Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Egypt requirements.
Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.
The working-day clocks the EDA publishes for each MeDevice stage, and the committee stages it leaves open.
23 of 25 research dimensions currently covered · 18 official sources · latest verification 2026-08-30
EDA registration fees in EGP · reviewed 2026-08-25
| Fee line | Amount | Provenance |
|---|---|---|
| Registration application - locally produced medical device | EGP 5,000 | Verified |
| Registration application - imported medical device | EGP 7,000 | Verified |
| Import permit - invoice value under EGP 10,000 | EGP 500 | Verified |
| Import permit - invoice value EGP 10,000–50,000 | EGP 1,000 | Verified |
Egyptian Drug Authority (EDA) review clocks and planning ranges · EU-aligned general-device classes I, Is, Im, IIa, IIb, III; IVDs handled separately classification
| Class / pathway | Review clock | Planning total | Provenance |
|---|---|---|---|
| All classes — device holding an international quality certificate (imported or local)(EDA registration on the MeDevice platform under GL.CAMD.002) | 10-25 working days | 6-12 months | Verified |
| All classes — locally manufactured device with no international quality certificate(EDA registration under GL.CAMD.009 after a manufacturing-site inspection) | 30 working days | 1-2 years | Verified |
Newest official EDA headlines from the daily-refreshed feed — every row links directly to the authority publication.
Official EDA rules and guidance · 8 of 8 documents linked to official sources
The target market is carried into each tool. Add the product, evidence, or regulatory change you want to assess.
Structure company, product, model, approval, certificate, and evidence facts before starting Egypt work.
Connect the EDA route, evidence, labels, local role, timing, and dependencies to a wider launch plan.
Compare an existing authorization and evidence set against EDA administrative, testing, labeling, and dossier needs.
Map a product or manufacturing change to EDA evidence, notification, timing, and implementation questions.
Assess a current EDA update against one product and turn it into an owner-ready action workpaper.
Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Egypt (EDA).
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