Egypt Registration Holder
Gain compliant access to the Egyptian medical device market with our Egypt Registration Holder service.
Medical Device Registration in Egypt
Egypt is an attractive export market for device and IVD companies due to its consistent recent growth and high demand for imported devices. To sell a medical device in Egypt, you must register it with the Egyptian Drug Authority (EDA). EDA’s regulatory requirements are similar to those in other markets, including a classification scheme, technical file preparation, and, for foreign manufacturers, an authorized representative or in-country representative. In fact, EDA’s classification scheme for medical devices mirrors the classification structure in the European Union.
However, Egypt does have its own set of rules and requirements that must be strictly followed to gain market authorization. Many companies rely heavily on their authorized representative, known as an Egypt Registration Holder (ERH), to ensure the success of their registration application to the EDA and maintain compliance with all post-market obligations.
What is an Egypt Registration Holder?
Your Egyptian Registration Holder is your liaison with the EDA beginning with the registration phase and throughout the lifecycle of your device. The ERH plays a critical role in the marketing and distribution of your device in Egypt. Your ERH must have extensive knowledge of EDA’s requirements and expectations for documentation to fulfill the obligations of the role.
As your ERH, we will:
- Register your medical devices with the EDA on your behalf and ensure that the devices comply with the EDA requirements for marketing and distribution in Egypt.
- Oversee proper preparation and submission of all required documentation, as well as verify all medical devices falling under its scope meet the safety and quality standards set out by the EDA.
- Report incidents, recalls, and all other vigilance items; guarantee ongoing adherence to all applicable standards and regulations throughout the lifecycle of your device; and notify the EDA of any significant changes to your product.
Who can act as an Egypt Registration Holder?
With decades of experience in the global device market, MedEnvoy brings deep expertise in navigating Egypt’s regulatory process and a strong rapport with the EDA.
Labeling review to EDA requirements
Since the EDA allows scientific offices owned by agents who do not have the right to import goods into Egypt, labels will only bear the names and addresses of the manufacturer and country of origin. Once you prepare your labeling, we will review it to ensure it conforms to the EDA’s labeling requirements. Additionally, the importer of goods may print their name and address in Arabic on labels after importing locally.
Technical file preparation and review
We will prepare your existing technical documentation file(s) for submission to the EDA. Technical files prepared for other markets often require modifications and reorganization to satisfy the EDA’s requirements. We will ensure your documentation meets all applicable requirements based on your device’s classification.
Liaise with the EDA
We will be the main point of contact for communications with the EDA regarding your registration. We will provide the documentation required by the EDA, such as a Manufacturer’s Declaration of Conformity, CE Certificate, Certificate of Free Sales (CFS), and any additional required information. We also retain access to your Technical Documentation File for inspection by the EDA, only if requested.
FAQs
Is an Egypt Registration Holder required to sell devices in Egypt?
Yes. If your company does not have a legal entity in Egypt, you must appoint an in-country representative (ERH) to register your medical device with the EDA and comply with local regulatory requirements.
Can my distributor serve as my ERH?
Yes, but it is not recommended. While technically possible, using a distributor as your ERH can lead to conflicts of interest, limited flexibility in choosing future distributors, and challenges with confidentiality and regulatory expertise. An independent ERH ensures impartial representation and regulatory focus.
What kind of documentation is required for EDA registration?
Required documents typically include the technical documentation file, CE Certificate, Certificate of Free Sales (CFS), Manufacturer’s Declaration of Conformity, and other classification-specific documents. Your ERH ensures this documentation is properly prepared and submitted.
EU Authorized Representative
UK Responsible Person
Swiss Authorized Representative
US FDA Agent
Mexico Registration Holder
Saudi Arabia Authorized Representative
India Agent
Australian TGA Sponsor
New Zealand Sponsor
Isreal Registration Holder
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