Navigating the Regulatory Landscape of MENA's Second-Largest Medical Device Market

Egypt's position as the second-largest medical device market in the MENA region, combined with its low local production, makes it a highly import-dependent market. Recent regulatory changes, including the participation of foreign manufacturers in public tenders through registration with the Unified Procurement Authority (UPA), have further opened the market to international companies.

Device Classification and Regulatory Pathways

Understanding Device Classifications and Regulatory Requirements in Egypt

Regulatory Authority

The Egyptian Drug Authority (EDA), established under Presidential Law #151 of 2019, is the key regulatory body overseeing the safety and effectiveness of medical devices, including IVDs. It operates separately from the Ministry of Health and is instrumental in regulating and supporting the local drug and medical device sectors to meet national needs.

Classification

Egypt follows device classification guidelines similar to reference markets such as the CE (European Conformity), US FDA, and Health Canada. Class I non-sterile devices are exempt from registration but must be listed with the importer’s record at EDA. All other classes, including sterile and non-sterile devices, require registration.

Key Requirements

Foreign manufacturers aiming to enter the Egyptian market must:

  • Appoint a local representative, either a commercial distributor with the necessary licenses or an EDA-licensed Scientific Office, to hold the registrations.
  • Compile a technical dossier for the registration process according to the device’s classification.
How We Can Help

Tailored Support for Market Entry

Our services are tailored to simplify your regulatory compliance and market entry:

  • Classification and grouping of your products to identify the appropriate regulatory pathway.

  • Compilation and submission of the technical dossier required for EDA registration.

  • Representation as your local representative, managing the registration with EDA and ensuring compliance with post-market regulations.

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Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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