Regulatory services Egypt
The Egyptian Drug Authority (EDA) is responsible for regulating the safety and effectiveness of medical devices
There is also the separate Egyptian Authority for Unified Drug Procurement, Medical Supply, and Medical Technology Management, who will handle all governmental hospital purchases of medical products.
There is no current legislation codifying the medical device regulatory requirements in Egypt, and most requirements are published throughout various Technical Committee decisions or known from practical experience in the market. As such, requirements can change without formal notice and evolve over time depending on the EDA’s shifting expectations. Currently, the EDA requires all medical devices except Class I non-sterile devices, standalone software and electronic reusable devices with a power cord, to be registered prior to import or sale in Egypt. It is advised to check the requirements for any particular device prior to proceeding with registration and commercialization in Egypt.
In any case, importation of medical devices of any class requires the manufacturer to be listed on the importer’s Importation Record and obtain an Import Permit for each shipment of devices.
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Notably, in some cases, especially for novel devices and devices manufactured in non-reference countries, the EDA will require a Scientific Committee review, which will extend the overall registration timeline. Evidence of marketing authorization in one of the following markets must be provided for registration in Egypt: EU, US, Canada, Japan, Australia or UK (so called reference countries).
Registrations are valid for 10 years from the date of issuance. If there are multiple changes or changes that affect the performance of the device, a new registration is required. Arabic is the official language of Egypt. English is acceptable for the application. However, the EDA reserves the right to ask for information in Arabic.
Classification and Grouping
Egypt does not have an independent classification system. Instead, the EDA generally refers to the classification in the EU or US. The EDA primarily follows the EU classification system of the Medical Devices Directive (MDD) 93/42/EEC.
Primary Market Operators
It is possible to identify several operators when selling products in the Egyptian market.
- Manufacturer: in general, the manufacturer would be the legal manufacturer that holds the marketing authorization in the reference country.
- In-country representative: for devices subject to registration, manufacturers without an office in Egypt must appoint a local operator as the Egyptian Registration Holder (ERH) to submit the registration application and act on their behalf in the country, including importation and vigilance reporting. The ERH is responsible for coordinating the importation of a registered device, including obtaining an Import Permit for each shipment. The ERH must be properly licensed with the EDA in order to perform their tasks. It is possible to have multiple registrations through different ERH’s (importers), if desired.
Alternatively, manufacturers with a local “Scientific Office” in Egypt can appoint this office as their ERH. The Scientific Office must have at least two Egyptian citizens with degrees in Pharmacy on staff and must have proper business licenses in Egypt.
- Importer: for devices subject to registration, the ERH is also the importer, unless the manufacturer has a Scientific Office in Egypt, in which case the distributor assumes the role of importer (as Scientific Offices generally do not have the qualifications to import on their own).
The ERH/importer must hold all required business licenses to import, including an Importation Record with the EDA. If importing reusable medical devices that require maintenance, the ERH/importer must additionally have a licensed medical store and service center.
For devices that are not subject to registration, manufacturers must still appoint an importer, who will apply for the required Import Permits.
- Distributor: local distributors must have all proper business licenses as well as a legalized contract from the manufacturer proving the commercial relationship between them. Like importers, distributors promoting reusable medical devices that require maintenance must have a licensed medical store and service center.
Where a manufacturer’s Scientific Office is appointed as the ERH, the importing distributor must fulfill the same requirements as importers.
The registration process
Class I non-sterile
Class I non-sterile devices are currently not subject to registration and must only be listed on the importer’s Importation Record. Additionally, Import Permits must be obtained for each shipment. The importer will apply for each of these.
Class I sterile, IIa, IIb, III, and AIMD
For devices that are subject to registration, once the registration dossier is ready for submission, the ERH will submit the application to the EDA.
In general, the roadmap differs per class and whether the product is non-sterile or sterile (Class I). Gateway MedTech can provide you with the details of the currently applicable roadmaps (including the steps in case a Scientific Committee review is required). We can also provide you with the technical documentation required for the different classes.
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Clinical data
No clinical data is submitted for import approval of Class I non-sterile devices in Egypt. As for the other products: while clinical data is not required for the registration submission, the EDA may request additional information if they deem it necessary for approval, particularly if the device is subject to a Scientific Committee review. Therefore, it is possible that existing clinical data will be requested by the EDA during the review.
Local testing
No device testing is needed for import approval of Class I non-sterile devices in Egypt. As for the other products: some devices may require testing at NODCAR. Also, the EDA requires testing of all shipments of sterilized medical devices at NODCAR before the release for sale.
Labeling
Labeling follows the EU requirements and international standards. English-only labeling is acceptable for professional-use devices, while devices intended for use by the public must include labeling in both Arabic and English. The ERH/importer must also be identified on the label. The registration number, if applicable, may also appear on the label and IFU. The EDA may accept electronic IFUs (e-IFUs), as long as a paper copy can be provided within 7 calendar days upon request. The acceptability should be checked for each specific device.
Approval from the EDA is required for the content of any advertising/marketing material before being used in the media (e.g. television, social media or magazines).
Quality Management System
No QMS certifications are submitted for import approval of Class I non-sterile devices in Egypt. As for the other products: ISO 13485:2016 certification is required for registration of medical devices in Egypt, unless the manufacturer provides a CFG citing compliance to the US GMP.
Cost
Gateway MedTech can provide you with the details of the currently applicable costs for product registration, import approval and customs release per shipment of devices. There is a fast-track route to expedite the registration timeline which is more expensive.
Time-to-Market
Class I non-sterile
Class I non-sterile devices are currently not subject to registration. The process of adding a manufacturer and device(s) to the importer’s Importation Record and obtaining the Import Permit takes approximately 2 months.
Class I sterile, IIa, IIb, III, and AIMD
Upon submission of the registration dossier the process would typically take around 12 months. However, this doesn’t include time taken by the manufacturer to respond to EDA requests for additional information, so the total timeline may be longer. A Scientific Committee review will extend the timeline with another month. Testing at NODCAR requires around 6–8 weeks.
The process of adding a manufacturer and device(s) to the importer’s Importation Record and obtaining the Import Permit takes approximately 2 months.
The EDA has established fast-track as an expedited route for registering single-use medical devices. The review time can be reduced to 8–10 months. Renewal and modification applications for single-use devices may also be submitted via fast-track.
Inspections
The EDA may conduct an inspection of each shipment of imported sterile medical devices before release for sale. This inspection occurs after the shipment is released from customs to be stored at distributor’s warehouse. The distributor or ERH contacts the EDA inspection department and arranges for samples to be taken for sterility analysis at NODCAR. If the results of the inspection match what is provided in the sterility analysis report, the shipment is released for sale.
Post-Market Surveillance (PMS)/Vigilance
The EDA collects and evaluates post-market information on medical devices, with a particular focus on adverse events/incidents and post-market vigilance. The guidelines are similar to those in the EU.
If a device is involved in an incident, either the manufacturer or the ERH must immediately notify the EDA and then submit an incident report.
