Egypt medical device regulations

EDREX: GL.CAMD.005 version 02/2026 (issued 05/2026; 21 pages), issued under EDA chairman decree 499 of 2021: UDI requirements for all medical devices, accessories, and IVDs supplied to the Egyptian market — Chapter One (UDI-DI and production identifier, issuing entities, data carriers and direct part marking), Chapter Two (additional labeling requirements), Chapter Three (import and distribution control), Chapter Four (compliance dates), Chapter Five (UDI in healthcare delivery), and the definitions/abbreviations annex. Applies to manufacturers, agents, importers, distributors, and healthcare providers. URL updated to the current v02/2026 file on the official guidelines index; the previously recorded media URL is a stale hash that now returns the Arabic homepage.

EDREX: GL.CAP.Care.040 version 1/2025 (issued November 2025; issued by the Central Administration of Pharmaceutical Care, General Administration for Pharmaceutical Vigilance): the medical device vigilance system operated with the Medical Devices Safety Unit (MDSU) — stakeholders' roles (users, manufacturers, MDSU), manufacturer pre-market obligations for registration/re-registration, post-market surveillance (PMSR and PSUR reporting, trend reporting), adverse-event incident reporting with timeframes and IMDRF coding, field safety corrective action (FSCA) and field safety notice (FSN) notification, and the reporting form annexes (user feedback, UIR, declarations, MIR, PSR, trend report, FSCA/FSN forms; annexes 2-13 extract as form tables without standalone headings and fold into one block). Supersedes the 2013 edition listed in its references. Not on the current CA-of-Medical-Device guidelines index, but the official URL still serves the PDF.

EDREX: GL.CAMD.002 version 02/2025 (issued 09/2025; 56 pages): registration procedures for imported and local medical devices holding international quality certificates (CE, FDA, reference-country certificates) — separate procedure tracks for sterile devices (receiving, evaluating, and completing registration files on the electronic platform) and non-sterile devices (Class IIa/IIb/III imported and local, system and bundling registration, 18-month importation windows for temporary acceptance numbers), specialized scientific committees including stability and biocompatibility evaluation, re-registration, general requirements, and Appendices 1-6 (document lists for imported, local, and F-Toll manufacturing submissions). URL updated to the current v02/2025 file on the official CA-of-Medical-Device guidelines index; the previously recorded media URL is a stale hash that now returns the Arabic homepage.

EDREX: GL.CAMD.009 version 02/2025 (issued 01/09/2025): the registration pathway for locally manufactured medical devices from factories holding ISO 13485:2016 certification without a CE certificate — EU-MDD Annex IX classification, factory technical requirements (manufacturing-site conditions, room layout, sterilization, controlled and clean rooms, HVAC/air handling), pre-registration procedures (technical operation license, pilot-batch sampling and analysis, 120-working-day corrective-measures window), registration procedures, and Annexes I-III (document list, factory technical requirements, vigilance obligations). URL updated to the current v02/2025 file on the official guidelines index; the previously recorded media URL is a stale hash that now returns the Arabic homepage.

EDREX: GL.CAMD.007 version 02/2025 (issued 09/2025; 48 pages): import approval procedures for all medical device types — import permits for registered devices (receiving, evaluating, completing files, issuing and amending permits via the medevice.edaegypt.gov.eg platform), separate tracks for exhibitions/workshops/training, research protocols, production inputs and raw materials for local factories, and custom release; annual import plans through the Medical Devices Import Plans Unit; the scientific evaluation and special import requests units; Appendices I-X (document requirements per application type and the quality/trading certificate matrix by classification); and the regulatory decisions with their timeframes. URL updated to the current v02/2025 file on the official guidelines index; the previously recorded media URL is a stale hash that now returns the Arabic homepage.

Issue 2022: minimum labeling requirements for medical devices, medical and laboratory equipment, in vitro diagnostics, and their components and production inputs circulated within Egypt — the minimum data that must appear on labels of imported or locally manufactured devices, labeling details for production components and inputs, and general requirements. The English version states that the Arabic text prevails in case of inconsistency (the bilingual disclaimer repeats on every page). No longer listed on the current CA-of-Medical-Device guidelines index, but the official URL still serves the PDF.

Egypt uses a 4-class risk-based classification system (Class I, IIa, IIb, III) aligned with GHTF/IMDRF principles. Classification determines registration pathway.

Establishes EDA as the regulatory authority for pharmaceutical products and medical devices. EDA reports to the Prime Minister and regulates quality, effectiveness, and safety.