Registration of Medical Devices in Egypt
As a medical device manufacturer looking to access the Egyptian market, you must register your products with the Egyptian Drug Authority (EDA) to legally import, promote and sell them in Egypt. The EDA is the regulatory body responsible for medical devices registration and marketing authorization. Successfully registering your devices requires navigating the EDA’s multi-step process, understanding the country’s regulatory requirements, and ensuring your submission dossier is comprehensive and compliant. Though the road to registration can be long, following the proper procedures and maintaining open communication with the EDA will help get your medical devices approved and available to patients and healthcare providers across Egypt. With a population of over 100 million and increasing demand for advanced healthcare, Egypt represents an attractive growth market for global MedTech companies.
The Egyptian Drug Authority (EDA) is Egypt’s regulatory agency responsible for the registration and approval of medical devices for commercial use. To register a medical device with the EDA, it is important to understand their regulations and procedures.
The EDA classifies medical devices into three risk-based classes according to their intended use and indications: Class I (low risk), Class IIa & IIb (medium risk), and Class III (high risk). The classification of your device will determine the registration pathway. Higher risk devices typically require more rigorous evaluation.
In line with Egypt’s Vision 2030 and strategy to establish the basis for digital transformation, and to complete the steps taken by the EDA to become a digital body, all of its services are digitally provided to facilitate the recipients of those services and to achieve a better vision for decision makers. Therefore, the EDA has launched the “MeDevice” platform on July 11th 2021 as a platform for medical devices importers, distributors and scientific offices to submit all their applications.
For Sterile Medical Devices, products need to be submitted through “MeDevicce” portal where it should take around 3 to 5 working days to decide whether the file should be accepted to move on to the next step or if there are comments, this needs to be fulfilled prior to the next step. Once accepted, the file will move forward where it will be evaluated by: the scientific committee, vigilance department, and the stability committee. This evaluation should take around 7 to 20 working days (depends on whether the file is submitted via the normal or the fast track). The applicant should then ensure to respond to any comments raised by EDA within 60 working days otherwise the file could be rejected and the application will have to be re-submitted again as a new application. To summarize, below the steps that need to be taken to submit a registration file for a sterile medical device:
For non-sterile medical devices (Class IIa, IIb and III), the applicant can either submit a full registration file and follow the same path applied to sterile medical devices or they can submit an initial registration file while following the below steps:
Submit the initial registration file to: nonsterileeg@edaegypt.gov.eg.
The file should include the following documents:
*for Class IIa devices. A Free Sales Certificate can be submitted from a non-reference country while ensuring that another certificate is submitted from a reference country within 6 months.
A temporary acceptance number shall be given to the file submitted by the EDA
The applicant shall then submit a full registration file within 6 months of obtaining the temporary acceptance number and 18 months to finalize the registration file and obtain the approval certificate
As per the EDA’s guidelines, a group of non-sterile medical devices can be bundled together if the following criteria are met:
There’s an additional road for the medical devices with the below specification. This is the Scientific Committee Approval pathway. it’s implemented for:
The EDA’s vigilance department is involved in the registration process of medical devices that are classified as Class IIb or class III. However, it could also be involved with Class Is and IIa medical devices if those devices require further regulatory action. The applicant needs to submit a declaration letter from the manufacturer and the applicant declaring to comply with the vigilance regulations set by EDA and to declare to report any global recalls, Field Safety Notices or Field Safety Corrective Actions to EDA while also reporting any incidents that occur in Egypt.
Medical devices registration licenses are valid for 10 years. The applicant is required to submit an initial request to renew/ re-register the licence during the first 3 months of the last year of the validity of the license.
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