The Central Administration of Medical Devices of the Egyptian Drug Authority, regulates all medical devices in Egypt.
Medical Device Definition
A medical device in Egypt means any device, instrument, material, machine, equipment, or application, including what is implantable, an electronic program (software), material, or any other similar or related things that the manufacturer has manufactured for human use, singly or in combination, for one or more of the following purposes:
Provided that the intended primary purpose is not achieved through pharmacological, immunological, or metabolic effects in or on the human body, the medical device can be assisted in its intended function by the aforementioned effects.
- Diagnosis, prevention, monitoring, treatment, and mitigation of disease.
- Diagnosis, monitoring, treatment, mitigation, and injury compensation.
- Verification of replacement, modification, or support of an anatomical or functional process.
- Support or sustain life.
- Sterilization of medical devices
Medical Device Classification System
||Surgical instruments, bandages, and non-invasive diagnostic devices.
||Endoscopes, surgical lasers, and some types of imaging equipment.
||High- Moderate risk
||Artificial joints, pacemakers, and certain types of imaging equipment.
||Heart valves, heart pumps, and neurostimulators.
||6-12 months approximate
|License validity period
||New Registration :-
From 2 to 10 devices, Normal Track: $226.52, Fast Track: $711.93.
- Evaluation/Examination of an Imported Medical Device Registration File: Normal Track: $98, Fast track Registration :- $421
- Registration of non-sterile Medical Devices using the Bundling system: (Medical Devices are divided into groups).
From 11 to 20 devices, Normal Track:291.24, Fast Track: 776.65.
From 21 to 30 devices, Normal Track: 355.97, Fast Track: 841.37.
From 31 to 40 devices, Normal Track: 420.69, Fast Track: 906.09.
From 41 to 50 devices, Normal Track: 485.41, Fast Track: 970.81.