Medical Device Regulatory Requirements in Egypt

Regulatory Authority Egyptian Drug Authority (EDA)
Regulatory Authority Website Link Click Here
Device Classification I,II,III,IV
Medical Device Regulations Regulatory Guideline for Procedures of Registering Imported and Local Medical Devices holding International Quality Certificates | Click Here
IVD Classification A,B,C,D
In Vitro Diagnostics Regulations Regulatory Rules of Registration and Market authorization of In Vitro Diagnostic Medical Devices
Registration Process Refer to Heading 4 for the registration process of medical device | Click Here
Registration Timeline approximately 7 months
Requirement of Authorized Representative Yes
Language Requirement Labels must be in Arabic (for home-use products) and English Language
Labeling Requirements

Labeling requirements for medical devices

| Click Here
Certificate of Free Sale

The free sale certificate that is issued by the Ministry of Health of the country of origin if it is a reference country (or a free sale certificate from one of the reference countries if the country of
origin is a non-reference country) and that includes the trade name, codes or sizes of the device and contains the legal manufacturer and the actual factory manufacturer (if any).

OR

The CFG certificate that is issued by the USFDA for the device and that includes the trade
name and the codes of the devices and contains the legal manufacturer and actual manufacturer

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Post Market Surveillance

Guidance for Implementing the Updated Safety Requirements for Medical Devices in Registration, Re-registration, Variation process and
 Post-marketing process

| Click Here
Reportable Incidents

An adverse incident is an event during use of the device which might lead to or might have led to death of a patient, or user or of other persons or to a serious deterioration in their state of health
should be reported to the MDSU/EDA.

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Adverse Event Reporting Timelines

Timelines
1. Serious public health threat: Immediately not later than 2 days after the manufacturer becomes aware of that threat.

2. Death or an unanticipated serious deterioration in a person's state of healt

Field Safety Corrective Action

Refer Section 5: The Egyptian Guideline for Medical Device Vigilance System

| Click Here
Recalls

Guidelines On Recall & Rapid Alert System For Medicinal Products

| Click Here
Additional Information

Re-registration of medical devices shall be every 10 years based on a request submitted to the Central Administration for Medical Devices.
Contact Email info@edaegypt.gov.eg
Contact Address El Manial, Agouza, Haram, Maadi, Mansouriya
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.

The above information is last updated on 07/Sep/2025

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