Egypt medical device registration timeline
Source-linked clocksEgyptian Drug Authority (EDA) review clocks and end-to-end planning ranges, using the EU-aligned general-device classes I, Is, Im, IIa, IIb, III; IVDs handled separately classification system.
| Class / pathway | Review clock | Planning total | With prior approval | 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 |
Review clocks exclude applicant hold time · planning totals are estimatesPlanning steps and estimates; these are not regulator deadlines.
Egypt Medical Device Registration Process
Step-by-step EDA registration process. Total estimated timeline: 6-12 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by EDA. Appoint a Egypt Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to EDA including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksEDA reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
10-25 working daysIn-depth technical assessment of device safety and performance. EDA may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, EDA issues Egypt market authorization certificate.
Priority handling outside the waiting list. GL.CAMD.002 §4.1.1-4.1.2 cuts the intake decision from 5 to 3 working days and the evaluation round from 20 to 7, so the published EDA clock to the first requirements round falls from 25 to 10 working days.
Eligibility: Defined in the guideline as the priority route for variations, but the registration guideline applies the same fast-track periods to registration requests
- Egypt Authorized Representative
- Arabic labeling
- ISO 13485:2016 certification
- Free Sale Certificate — from a reference country for Class IIb and III, from the country of origin for Class IIa; the guideline lists 37 reference countries
- Certificates submitted with the file must have at least 3 months of validity remaining
- Import approval is a separate MeDevice application: 2 working days for the intake reply, 3 working days to send requirements, and the permit is valid for one year (GL.CAMD.007 §4.1)
- Variations run on their own clock: 8 working days intake and 25 working days evaluation on the normal track, 5 and 10 on the fast track (GL.CAMD.003)
- Re-registration: every 10 years, with initial acceptance required within the first 3 months of the last year of validity
Reviewed 2026-08-30. End-to-end totals remain planning estimates.