Egypt is an attractive market for medical device manufacturers, but navigating the specific requirements for medical device registration in Egypt can be daunting. The medical device market is valued at over $4 billion, making it the second-largest market in the Middle East and North Africa (MENA). And, the local healthcare infrastructure relies almost entirely on imported medical technology, as very few devices are manufactured domestically.
In 2018, the Egyptian Drug Authority (EDA) expanded the medical device registration requirement to all devices (with some exemptions). In this article, we’ll review the process to legally sell your device in Egypt so you know what to expect and can take steps to ensure your registration is successful.
The EDA enforces Egypt’s regulatory framework, including the requirements in the key regulation: Egyptian Medical Device Law No. 10 of 2003. All devices must be registered with the EDA before they can be imported to Egypt. Some devices are exempt from registration but must be included in the importer’s EDA record. All companies without a presence in Egypt must hire an authorized representative, called an Egypt Registration Holder (ERH). The ERH is also your importer for registered devices.
Egypt’s regulatory structure leverages prior authorizations in other major markets, such as Europe, the US, Japan, Australia, or Canada. Your reference market can determine the documentation required for your registration application, but, in general, will require a combination of the following documents:
EDA requires a valid ISO 13485:2016 certificate from all applicants to satisfy its quality management system (QMS) requirements. If you are leveraging clearance with the US FDA, EDA will accept a Certificate of Foreign Government (CFG) that certifies compliance with 21 CFR Part 820. The registration process does not include an additional QMS inspection or audit by the EDA.
Your technical file should be structured according to EDA’s requirements, which can vary depending on your device classification, characteristics, etc.
Egypt does not have its own classification scheme. In general, it references the classification hierarchy in the EU Medical Devices Regulation (EU MDR 2017/745):
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If you are leveraging authorization in a market other than Europe, EDA will follow the classification scheme in your reference market. However, if your device is registered at a higher risk level in another acceptable market, EDA may require you to use the higher risk authorization as your reference market and impose a more rigorous review process.
If your company does not have a presence in Egypt, you will need to appoint an authorized representative, called an Egypt Registration Holder (ERH). Your ERH is essential to the device registration process and should be the first task on your roadmap toward marketing your device in Egypt.
Your ERH effectively owns your registration in Egypt, acts as the local importer, and keeps you informed of any regulatory changes or post-market obligations to ensure you can continue marketing your product in Egypt without disruption.
It’s important to choose an experienced ERH who is dedicated to the key functions of this essential role. Your ERH should be deeply knowledgeable of EDA’s requirements and expectations, as you will often lean on their expertise to ensure the success of your application. Choosing an ERH is a long-term commitment, as the name and address of your ERH will appear on the labeling and Instructions for Use (IFU) for all your products distributed in Egypt. As such, changing your ERH also means reprinting all product labeling.
Registration applications are submitted by your ERH via the EDA’s online portal, MeDevice, along with your technical documentation. Once submitted, EDA will notify your ERH within three weeks (approximately 20 days) if the application is accepted and the official review is underway.
EDA’s stated review timeline is 4-9 months. Your device’s classification, along with other device characteristics (e.g., sterile/non-sterile, intended use, etc.), will determine if additional organizations and/or scientific committees within Egypt’s regulatory structure must review your registration documentation. These variables can significantly affect the approval timeline. For example, if your device is non-sterile, EDA may authorize importation before the registration is approved. For sterile and/or higher-risk devices, you must wait until registration is approved to begin the import permitting process.
A fast-track route is available for single-use devices, in which initial application acceptance is reported within 3-4 days and application review is completed within 3-4 months. However, this route does carry higher fees and can still take longer than the official timelines if issues arise during the review process.
It’s important to understand what, if any, intended use- or device-specific requirements exist for your product so you can account for the longer review timeline as well as include any additional documentation in your initial submission. If the EDA requests further documentation, testing, or clinical data during the review process, it is essential to fulfill their request as quickly and as thoroughly as possible.
Once your registration is approved, it is valid for 10 years.
Once approved, importation can begin. To legally import your device, the manufacturer and devices must be listed on the ERH’s Importation Record with the EDA. Your ERH must also obtain an Import Permit. Obtaining the Importation Record and Permit can take approximately 6-8 weeks.
Device registration in Egypt is relatively efficient, as it leverages your efforts to obtain authorization in other markets. However, the process is not without its potential obstacles and most device manufacturers benefit from the help of regulatory experts to complete the registration process. MedEnvoy’s team of regulatory consultants brings decades of combined experience navigating regulatory schemes around the world . In partnership with Hadina 4 Trade in Cairo, we can act as your Egypt Registration Holder and help you navigate the device registration process.
