Egypt Medical Device Regulations

Regulatory Agency

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:

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.
Contraception.
Sterilization of medical devices

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.

Medical Device Classification System

International Classification	Low Risk	Examples
Class I	Low risk	Surgical instruments, bandages, and non-invasive diagnostic devices.
Class IIa	Low–moderate risk	Endoscopes, surgical lasers, and some types of imaging equipment.
Class IIb	High- Moderate risk	Artificial joints, pacemakers, and certain types of imaging equipment.
Class III	High risk	Heart valves, heart pumps, and neurostimulators.

Regulatory Approval Process

Classification	Approval procedure
Class I	1.Approval procedure for Sterile Medical Devices and Non-Sterile Medical Devices that have complete registration files: Appoint an authorized representative (AR) in Egypt to submit the application. Applicant shall pay fees needed. Applicant will submit the file through following link in order to receive acceptance of the file to be reviewed. Completion of the registration file according to requirements checklist published by the Authority. Authority will update the applicant about the status of the file through the MeDevice platform within 5 working days from the date of the file submission for the normal track, and 3 working days for the fast track, by accepting or not accepting the file or suspending it until it is fulfilled. File evaluation step. After evaluating (Normal track within 20 working days, Fast track within 7 working days) an E-Mail sent from the Authority to the company/applicant include the needed requirements. Requirements need to be fulfilled within 60 working days by the company/applicant in the MeDevice platform. Final file Revision by the Authority. If the file accepted: Registration License will be issued. The company will be given a permanent acceptance number. Then Authority will issue a valid Registration License. 2. For Non-Sterile Medical Devices If only an initial registration file is available, that is, it does not include all the requirements for registration: In parallel, the applicant for registration submits an initial registration file at the following link: md.nonsterilereg@edaegypt.gov.eg which contains a copy of the certificates submitted to the General Administration to allow the importation for the circulation for each medical device. The Authority will provide the applicant with a temporary acceptance number. The import approval is issued after obtaining the initial temporary number through the Registration Department. Applicants are given 18 months from the date of acceptance of the initial registration file to complete the rest of the registration file. During the first 6 months are to complete the essential documents in the registration file (based on the requirements published by the Authority to complete the registration of a complete file as per annex-1) through the following link: medevice.edaegypt.gov.eg. After that, the company is granted a final acceptance number, and then the company is given one year to import until the completion of the registration procedures.
Class IIa
Class IIb
Class III

Additional Information

Approval timeline	6-12 months approximate
License validity period	10 years
Fees	New Registration :- 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 2 to 10 devices, Normal Track: $226.52, Fast Track: $711.93. 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.

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