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

Medical Device: any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
diagnosis, prevention, monitoring, treatment, or alleviation of disease.
diagnosis, monitoring, treatment, alleviation of, or compensation for an injury.
investigation, replacement, modification, or support of the anatomy or a physiological process.
supporting or sustaining life.
control of conception.
cleaning, disinfection, or sterilization of medical devices.
providing information by means of in vitro examination of specimens derived from the human body.
and does not achieve its primary intended action by pharmacological, immunological, or metabolic means in or on the human body but which may be assisted in its intended function by such means.

Imported Medical Devices: Devices which are completely manufactured abroad and imported to be sold and placed on the market within the Arab Republic of Egypt.

Active therapeutic device: Any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness or injury.

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

4-10 months approximate

License validity period

10 years

Fees

New Registration :-

Evaluation/Examination of an Imported Medical Device Registration File: Normal Track: $59, Fast track Registration : $258
Registration of non-sterile Medical Devices using the Bundling system: (Medical Devices are divided into groups).