Egypt

1/5/2023

Guideline for Good Regulatory Oversight of Clinical Trials by Egyptian Drug Authority. This guideline outlines clinical trial package application of all types of IMP, any further specific guidance will rely on this guideline and must be read in conjunction with it.

1/11/2023

Amendment procedures for registered medical devices (IFU, Labeling, Artwork). Amendment procedures for registered medical supplies regarding instructions for use and labeling and artwork as a result of the application of Medical devices regulation 745/2017 (MDR).

03/15/2023

Regulatory Procedure The document provides the regulatory procedure for importing and registering medical and laboratory supplies, devices, and diagnostic reagents circulated in Great Britain (England - Wales - Scotland) and are not required to be circulated in the European Union.

09/08/2022

Circular: Examination, Re-examination Fees for IVDs. Examination, Re-examination Fees for the files of In-vitro diagnostic devices and laboratory reagents are provided to the General Administration to allow circulation in groups.

01/24/2022

Guidance on Requirements for Unique Device Identification (UDI) for Medical Devices. "This guidance applies to the following: A. All medical devices, their accessories, and IVDs that will be supplied to the Egyptian market, except medical devices and IVDs for research or investigational, custom-made. B. Manufacturers, agents, importers, distributors, and healthcare providers. "

How can RegDesk help?

RegDesk is an AI-powered Regulatory Information Management System (RIMS) designed to simplify global compliance for medical device companies. With regulatory intelligence covering 120+ markets, RegDesk helps you prepare and publish global submissions, manage standards, conduct impact assessments, and stay ahead of regulatory changes all from a single, centralized platform. Expanding into new markets has never been easier.