EDA Egypt Medical Device Registration

The primary regulatory authority for medical device registration in Egypt is the Egyptian Drug Authority (EDA Egypt). Pure Global can assist with navigating the registration process to ensure EDA approval for selling medical devices in the Egyptian market.

Egypt follows device classification guidelines similar to those in reference markets such as the CE (European Conformity), US FDA, and Health Canada. For medical device registration in Egypt, 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.

Foreign manufacturers must: Appoint a local representative, either a commercial distributor with the necessary licenses or an EDA-licensed Scientific Office, to hold the EDA registration. Compile a technical dossier for the registration process according to the device’s classification.

Recent regulatory changes include the participation of foreign manufacturers in public tenders through registration with the Unified Procurement Authority (UPA). This change has further opened the market to international companies, enhancing opportunities for foreign manufacturers to enter and compete in the medical device registration Egypt market.