Egypt - Top Medical Device Alerts

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.
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).
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.
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.
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. "
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