Egypt medical device registration timeline

Source-linked clocks

Egyptian 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.

2 pathways2 of 2 clocks verifiedvalidity 10 years — GL.CAMD.002 §9 issues the registration report for 10 yearsMDSAP not acceptedreviewed 2026-08-30edaegypt.gov.eg

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	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)	30 working days	1-2 years	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Planning 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 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by EDA. Appoint a Egypt Authorized Representative.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to EDA including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

EDA reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

10-25 working days

In-depth technical assessment of device safety and performance. EDA may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, EDA issues Egypt market authorization certificate.

Summary: The Egypt medical device registration process through Egyptian Drug Authority (EDA) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Expedited pathways

Fast track25 → 10 working days to the first requirements round

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

Prior approval recognition

FDA 510(k)A 510(k) clearance plus an FDA CDRH export certificate satisfies the free-sale evidence for a reference country

EU CE MarkA CE certificate and ISO 13485:2016 are the international quality certificates that open the GL.CAMD.002 route; Class I non-sterile devices are exempt from the CE requirement

Key requirements

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

Primary regulator sources

edaegypt.gov.eg · EDA Regulatory Guideline for Procedures of Registering Imported and Local Medical Devices holding International Quality Certificates (EDREX: GL.CAMD.002, version 2, effective 09/2025) — §4.1.1 intake response, §4.1.2 evaluation, §9 ten-year licence edaegypt.gov.eg · EDA Regulatory Guideline of Registration of Locally Manufactured Medical Devices not holding International Quality Certificates (EDREX: GL.CAMD.009, version 2, effective 01/09/2025) — §6 pre-registration inspection and §6.1-6.3 registration clocks edaegypt.gov.eg · EDA Regulatory Guideline of Issuance of Import Approvals of All Types Medical Devices (EDREX: GL.CAMD.007, version 2, effective 01/09/2025) — §4.1 two-working-day intake reply, three-working-day evaluation and one-year import permit edaegypt.gov.eg · EDA Regulatory Guideline for the Procedures and Rules Organizing the changes done to a Registration License Data of a Medical Device (EDREX: GL.CAMD.003, version 03, effective 01/09/2025) — 8/5 working-day intake and 25/10 working-day evaluation for normal and fast track

Reviewed 2026-08-30. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against EDA publications · full review 2026-08-30 · row IDs are stable — cite as registration-timeline:egypt:international-certificate-route