Regulatory Authority
Egyptian Drug Authority (EDA) and Drug Policy and Planning Centre (DPPC)
Classification
class I (low risk), class IIa and IIb (medium risk) and class III (high risk)
Quality system
ISO 13485:2016
To bring a medical device into Egypt, it must be registered with the Regulatory Authority. Class I, IIa and IIb devices must be registered with the Drug Policy and Planning Centre (DPPC) and Class III devices with the Egyptian Drug Authority (EDA).
To market a medical device in Egypt, a registration file must be submitted, which is assigned a temporary code that should include the declaration of conformity, the free sale certificate from the country of origin, the ISO 13485:2016 certificate and the EC certificate (strongly recommended) if already obtained.
The EDA is generally only involved in the registration process of class III Medical Devices. In this case, the importer must submit to the EDA a letter from the manufacturer and the importer itself declaring that they comply with the EDA’s vigilance regulations, reporting any recalls, warnings or field safety corrective actions related to other countries, and communicating any incidents that occurred in Egypt.
Applicant
The foreign manufacturer must appoint a local authorised representative (ERH) responsible for importing the devices in Egypt and in charge of post-market surveillance activities in the territory.
Timeframes and Costs
Reviewing the technical file may take up to 30 working days and the manufacturer is given 60 working days to respond to any comments raised by the EDA/DPPC. The DPPC, upon completion of the verification, issues an import approval, while the EDA issues a marketing authorisation and its verification activities can take up to 18 months.
Validity
Import licences are valid for ten years.
Documentation Language and Labelling
The labelling (labels and instructions for use) for Medical Devices for professional use can be made available in English while that for devices for domestic use in Arabic.
Useful Information
The EDA facilitates the entry into Egypt of Medical Devices already marketed in Europe, and therefore EC marked, and in countries such as the USA, Canada, Australia and Japan.
