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 to the EDA Egypt medical device registration process, 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
Medical devices sold in Egypt are regulated by the Egyptian Drug Authority (EDA). Pure Global can assist with Egypt's medical device registration and local representation, 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.
Act as your local representative, manage registration with EDA and ensure compliance with post-market regulations.
Frequently
Asked Questions
What is the primary regulatory authority for medical device registration in Egypt?
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.
How are medical devices classified in Egypt?
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.
What are the key requirements for foreign manufacturers to market medical devices in Egypt?
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.
What recent regulatory changes have impacted the Egyptian medical device market?
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.
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