In Egypt, medical device regulations are overseen by the Egyptian Drug Authority (EDA), and market access is contingent upon EDA Registration. Before a device is approved for sale, it must be categorized, technical documentation must be submitted, and it must comply with local regulations to ensure its efficacy and safety.

What is EDA?

The Egyptian Drug Authority (EDA), established in 2019, is responsible for regulating medical devices and pharmaceuticals in Egypt. To register a medical device, applicants must be legally registered entities in Egypt, and if the manufacturer is outside the country, a local representative is required. The registration process involves completing an official application form, providing detailed product information, and demonstrating compliance with quality management system standards, such as ISO 13485. Additionally, evidence of any existing regulatory approvals (e.g., CE marking or FDA clearance) and, depending on the device, clinical evaluation data may be necessary. Applicants must prepare a comprehensive technical file containing design and manufacturing information, pay applicable registration fees, and commit to post-market surveillance to report any adverse events related to the device. Overall, meeting these requirements is essential for successfully bringing medical devices to market in Egypt, and consulting the EDA’s official resources or local experts can further facilitate the process.

EDA Registration

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Navigating EDA Compliance with CAPA Approval

To succeed in the Egyptian market, securing approval requires meticulous compliance with the Central Administration of Pharmaceutical Affairs (CAPA). The Egyptian Drug Authority (EDA) oversees the regulation of medical devices and is instrumental in the approval process.

EDA Registation

Egyptian Drug Authority Registration Procedure

  • The EDA Registration process varies depending on the medical device class and type. At Operon Strategist, we streamline the entire process to ensure a hassle-free experience:
  • CAPA guidance: We assist you through every step of the registration process with CAPA.
  • Technical File Review: Our experts handle the technical file review process, ensuring all documentation is in order.
  • ERH Appointment: If you lack a local presence, we help you appoint a qualified Egyptian Drug Authority Registration Holder (ERH).
  • QMS Design: We help you align your Quality Management System (QMS) to meet ISO 13485 standards for full compliance.

Medical Device Classification in Egypt: 

The Egyptian Drug Authority (EDA) follows European risk–based classification system for medical devices. The medical device must have a CE mark to be placed in the Egyptian market. A CE mark will help to get registration approval from CAPA. Medical devices are classified into four categories namely:

Classification Type  

Risk  

Example  

Class I 

Low  

Tongue depressor, stethoscopes for diagnosis, non –invasive electrodes 

Class II A 

Low-Moderate  

Infusion pumps, syringes, Anaesthesia breathing circuits 

Class II B 

Moderate- High  

Orthopaedics implants, long term corrective contact lenses, insulin pens 

Class III   

High  

Coronary stents, spinal stents, breast implants  

How we Can Streamline Your EDA Registration Process?

Operon Strategist provides end-to-end regulatory consulting, including:

Device Classification: Tailored guidance on the classification of your medical device.

Design and Development: Expert support for manufacturing devices to meet regulatory standards.

ISO 13485 QMS Training: Ensure your Quality Management System aligns with ISO 13485.

Technical File Creation: Streamlined creation and organization of essential documentation.

Regulatory Submissions: Handle submissions and address queries for a smooth approval process.

ERH Selection Assistance: Expert guidance in selecting Egyptian Registration Holders for regulatory compliance.

Global Market Assistance

Whether you aim to manufacture, import, or export medical devices in Egypt, Operon Strategist is your partner in navigating the global market. Our comprehensive services extend to ensuring your products meet international standards.

Ready to embark on your EDA registration journey? Contact Operon Strategist today for a consultation!

We also provide medical device consultation for India, South Africa, Egypt, the USA, the UK, Costa Rica, Oman, and Iran. For free consultation Contact us now.