Egypt Medical Device Regulations

Agency

All medical devices are regulated by the Medical Device Department, Egyptian Drug Authority.

Medical Device Definition

A medical device is any medical device or machine tool application of medical or medical use, whether alone or with any other supplements such as those required for special applications are running, which developed for human use of the following goals and targets: Diagnose, prevent, or control or cure or mitigation of disease analgesia; Diagnosis, control or cure or mitigation of analgesia or compensation for any disability or disability; Check or compensation or to improve the work of Physiology and autopsy; Prevent pregnancy. Such as: Devices that are running through a power source; Devices planted the human body, and self-working power source; Purpose-designed equipment for specific purposes; Devices designed for clinical studies; Hardware diagnostic test. And which cannot be achieved through: Medical drugs; Immune serum; Metabolism.

Classification of Medical Device

International Classification	Description	Examples	Risk Level
Class I	Simple with history of safe use	Simple surgical instruments, tongue depressor	Low
Class II a	relatively low risk to the human body	Digestive catheters, infusion pumps, and powered wheelchairs	Low - Moderate
Class II b	Relatively high risk to the human body	Dialyzers, and orthopaedic implants	High - Moderate
Class III	Devices that may endanger the Patient's life	Coronary stents	High

Premarket Approval Process

Class I

Class II a

Class II b

Class III

Timeline

All Classes

Email Medical Device Department (MDD) asking for an appointment at mdr@eda.mohealth.gov.eg and wait for a response with meeting time

5 Days

First interview with MDD

20 working days

MDD will follow up after first review with further requests through email.

Submit Declaration of Conformity and Scientific & Stability comm. (if applicable). MDD will start final review and send email with final requests (if applicable).

45 working days

Medical device registration approval issued.

List of Required Documents

Pro-forma Invoice
A Free Sale certificate from reference country*
CE Certificate or FDA Approval
Include the original technical file
- composition of the product, test method, sterilization certificate, description of the product parts, labels, CoA, stability data, packaging configuration, IFU and catalog
Declaration of Conformity
Legalized Agency Agreement
Catalog or literature
GMP certificate or QM-system certificates (ISO 13485, ISO 9001)

* reference countries are Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Japan, Luxembourg, the Netherlands, New Zealand, Norway, Spain, Sweden, Switzerland, the UK and the USA

Obtain approval in

Egypt

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