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EDA EDREX:

EDREX: GL.CAMD.007

Regulatory Guideline of Issuance of Import Approvals of All Types of Medical Devices
EgyptEgyptian Drug AuthorityRegistrationEffective September 2025
What this code is

EDREX: GL.CAMD.007 is the official EDA identifier for “Regulatory Guideline of Issuance of Import Approvals of All Types of Medical Devices”. EDREX: GL.CAMD.007 is the official identifier EDA uses for this instrument.

Instrument
EDREX:
Full name
EDREX: GL.CAMD.007
Category
Registration
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English
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
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Dates
Published
September 2025
Effective
September 2025
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About this regulation

Regulatory Guideline of Issuance of Import Approvals of All Types of Medical Devices

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.

EDREX: GL.CAMD.007 is the official identifier EDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.