EDA · Middle East & AfricaEvery Egypt dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.
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.
Common questions about changing a registered medical device in Egypt. Each question separates published rules from details still awaiting verification.
23 of 25 research dimensions currently covered · 23 official sources · latest verification 2026-10-21
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) The published figure is the EDA-side clock through the first requirements round, not the time to a licence: §4.1.1 gives 5 working days for the intake decision on a normal-track request and 3 for a fast-track one, and §4.1.2 gives 20 working days to review the file and send requirements on the normal track and 7 on the fast track Nothing in the guideline puts a period on the scientific, stability or specialized registration committees that sit between the requirements round and the licence, which is why the country row is partially verified and the realistic range is an observed estimate rather than a clock Applicant-side caps: requirements must be met within 60 working days, and a request suspended for incomplete documents is cancelled after 90 working days The clock is route-wide — GL.CAMD.002 varies the dossier by class but publishes one set of periods for classes I through III Non-sterile IIa, IIb and III devices with only an initial file receive a temporary acceptance number that allows importation, then 18 months to complete the registration file, with the main documents due in the first 6 months | 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) Same caveat as the certificate route: 10 working days for the intake reply (§6.1) plus 20 working days to review the file and identify requirements (§6.2) is the published EDA clock to the first requirements round, and completions are then reviewed within 10 working days (§6.3) The route opens with a site inspection rather than a submission: the manufacturer has 20 working days for the technical-requirements check, 120 working days to complete corrective measures and an optional 40-working-day extension before the GMP inspection report is issued Local testing is real here — the Medical Devices Inspection Department draws samples from a pilot batch for analysis in EDA or EDA-approved laboratories, and the device must go to the specialized scientific committee and, where applicable, the stability and biocompatibility committee A file not completed within one calendar year of acceptance is cancelled; non-sterile devices get 6 months from submission to trade after the initial evaluation | 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
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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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