EDA Egypt Medical Device Registration
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.
Understanding Device Classifications and Regulatory Requirements in Egypt
Regulatory Authority
Pure Global can assist with Egypt's medical device registration, ensuring EDA approval to sell in the Egyptian market.
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.
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.
We Provide Access To 28+ Markets Worldwide
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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Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.