Market Intelligence
Medical Devices North Africa Egypt Export Regulations

Egypt Registration of Medical Devices

To market a medical device in Egypt, manufacturers must register their products with the Egyptian Drug Authority (EDA). The registration process involves several key steps:

  1. Appoint an Egyptian Registration Holder (ERH): Foreign manufacturers without a direct presence in Egypt must designate a local representative, known as an ERH. This entity, which can be a commercial distributor or an EDA-licensed scientific office, is responsible for submitting registration applications and maintaining post-market surveillance. 
  2. Classify the Medical Device: Egypt aligns its device classifications with international standards, generally referencing the European Union’s Medical Devices Regulation (EU MDR). Devices are categorized as Class I (low risk), Class IIa, Class IIb, or Class III (high risk). The classification determines the regulatory pathway and requirements. 
  3. Prepare Required Documentation: Essential documents include (these documents demonstrate compliance with EDA’s safety, quality, and efficacy standards):
    1. ISO 13485:2016 Certification
    2. Certificate of Free Sale from the country of origin
    3. Declaration of Conformity
    4. CE Certificate (if applicable)
    5. Technical File containing detailed product information
  4. Submit the Registration Application: The ERH submits the compiled documentation to the EDA through their electronic platform. The EDA reviews the application, a process that can take between 4 to 9 months, depending on the device classification and completeness of the submission.
  5. Obtain Approval and Maintain Compliance: Once approved, the registration is valid for 10 years. The ERH must manage post-market obligations, including vigilance reporting and adherence to any additional regulatory requirements.

It’s important to note that as of 2018, the EDA expanded registration requirements to include all medical devices, with certain exceptions. Navigating the registration process can be complex, so partnering with an experienced ERH can facilitate compliance and streamline market entry.

For more information, please reach out to Ms. Rania Mekhail.