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|
* 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