🇪🇬Egypt Medical Device Regulations

Guidance on Requirements for Unique Device Identification

UDI requirements for all medical devices, accessories, and IVDs supplied to the Egyptian market. Applies to manufacturers, agents, importers, distributors, and healthcare providers.

Regulatory Guideline for Registering Imported and Local Medical Devices with International Quality Certificates

Registration procedures for Class IIb, III devices and Class I, IIa devices with regulatory actions. Applies to imported and locally manufactured devices with CE, FDA, or other international certificates.

Regulatory Guideline for Registration of Locally Manufactured Medical Devices Without International Quality Certificates

Registration pathway for locally manufactured medical devices that do not hold CE, FDA, or other international quality certificates.

Regulatory Guideline for Issuance of Import Approvals for Medical Devices

Procedures for obtaining import approvals for all types of medical devices entering the Egyptian market.

Minimum Labeling Requirements for Medical Devices

Minimum labeling requirements for medical devices, medical and laboratory equipment, and in vitro diagnostics for circulation within Egypt.

Medical Device Classification System

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

Law Establishing the Egyptian Drug Authority

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

Egyptian Guideline for Medical Device Vigilance System

The Egyptian Pharmaceutical Vigilance Center monitors safety of medical products throughout their lifecycle. Manufacturers must report adverse events and field safety corrective actions.