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 ClassificationDescriptionExamplesRisk Level
Class ISimple with history of safe useSimple surgical instruments, tongue depressorLow
Class II a relatively low risk to the human bodyDigestive catheters, infusion pumps, and powered wheelchairsLow - Moderate
Class II bRelatively high risk to the human bodyDialyzers, and orthopaedic implantsHigh - Moderate
Class IIIDevices that may endanger the Patient's lifeCoronary stentsHigh
Premarket Approval Process
Class IClass II aClass II bClass 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 time5 Days
First interview with MDD20 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

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