Frequently Asked Questions
How are medical devices classified?
(MD) Egypt does not have an independent classification system. Instead, the EDA generally refers to the classification in the leveraged reference market, and if the classification is higher in any reference market, the EDA may expect for that market to be leveraged for the registration. The EDA most often refers to the EU classification system of the Medical Devices Directive (MDD) 93/42/EEC in their communications. Also, while not formalized in regulation, the EDA exempts certain categories of devices from registration, in practice; as these exemptions are not formalized, they are subject to change at the EDA’s discretion.
(IVD) Egypt does not have an independent classification system. The Regulatory Rules for the Registration and Circulation of Laboratory and Diagnostic Reagents rely on the device classification under the EU IVDD 98/79/EC. Mandatory registration of IVDs is currently being phased-in by the EDA according to the IVDD classification scheme (List A and List B IVDs, followed by Self-Testing and General IVDs). Notably, it is not clear whether the Rules will apply to all IVDs, or whether it is initially limited to "laboratory and diagnostic reagents" only. Whether registration of IVD equipment will be implemented according to the same schedule is not clear at this time.
Is home and/or reference country approval leveraged for registration?
(MD) Evidence of marketing authorization in one of the following markets must be provided for registration in Egypt: EU, US, Canada, Japan, or Australia. Notably, in order to leverage the US as the reference country, a US FDA Certificate to Foreign Government (CFG) is required, which is only issued for the export of devices by US establishments. For exempt devices, a CE Marking Certificate (if Class I measuring or higher) or CFS/CFG is required for import approval. Approval in the country of origin is not required for registration or import approval in Egypt.
(IVD) For registration and import approval dossiers, approval in either the EU, US, or Canada must be leveraged, and one of the following must be submitted:
• An appropriate EU CE Marking Certificate and/or Declaration of Conformity (according to the EU classification), plus a CFS from either the country of origin or a reference market (EU, Switzerland, Iceland, Norway, Australia, New Zealand, US, Canada, Japan, and the United Kingdom (UK))
• A US FDA CFG
• A CFS issued by Health Canada, plus the Canadian Medical Device Establishment License (MDEL) or Medical Device License (MDL)
Do the regulators manage a public database to search for the registrations in the country?
(MD) Registrations can be searched on the EDA website but only through a local company that has a user name and password to open the MeDevice platform.
(IVD) As imported IVDs are currently subject to registration in Egypt, there is newly published guidelines but without database for IVDs at this time.
Is an in-country representative required? Who “owns” the registration?
(MD) Manufacturers without an office in Egypt must appoint a licensed in-country representative, known as the Egyptian Registration Holder (ERH), to submit the registration to the EDA. The ERH must be the importer of the device and “owns” the registration in Egypt if it’s not a Scientific office. Manufacturers with a local Scientific Office in Egypt can appoint this office as their ERH. Devices that are exempt from registration must still appoint an importer to obtain an Import Permit.
(IVD) IVDs List A & B Reagents are currently subject to registration, an importer must be appointed to obtain an Import Permit. Further, mandatory registration is currently being phased-in, and the local importer will be responsible for submission of the registration dossier to the EDA on behalf of the manufacturer.
Can there be multiple representatives for the same device?
(MD/IVD) Yes, there can be multiple representatives (ERH/importer) for the same device, but they would need to each fulfill the relevant requirements separately (e.g., obtain registration and/or import approval from the EDA in their own name).
Fees and Timelines
What are the associated government fees?
(MD/IVD) A list of fees can be found on our Government Fee Finder Tool.
What is the average time-to-market per classification?
(MD) Upon submission of the registration dossier via the MeDevice portal, the EDA has stated that the reviewer will contact the ERH in around 20 business days to initiate the review. After accepting the dossier for review, the official EDA review timeline ranges from 4-9 months. However, this doesn't include time taken by the manufacturer to respond to EDA requests for additional information, so the actual timeline may be longer. For non-sterile devices, the EDA may authorize importations in the meantime, as long as the application has been submitted.
Also, a Fast Track route is available for single-use devices as an expedited registration route, subject to a higher fee. The EDA has stated that the reviewer will contact the ERH in only 3-5 business days after submission to initiate the review, and in practice, the review time can be reduced to 3-4 months, barring significant comments from the reviewers.
If a Scientific Committee review is required, this wasn’t tested after applying MeDevice. It’s not clear at this point if it will go through local testing (like in Dental or Ortho) or not.
If analysis at the National Organization for Drug Control and Research (NODCAR) is required, this extends the review time by 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 6-8 weeks.
(IVD) The process of adding a manufacturer and device(s) to the importer's Importation Record and obtaining the Import Permit takes approximately 6-8 weeks.
For the registration of IVDs, the following official timelines are defined by the EDA:
• Once the application is accepted, the initial review will be completed within 20 business days
• In case the EDA requests additional information, supplemental documentation must be submitted within 60 business days; if more time is needed, it is possible to request an extension of 30 business days
• The EDA will review the supplemental documentation within 10 business days and issue a technical report on the application within another 5 business days
Roadmap and Technical Dossier Prep
Document Preparation
Does the in-country representative need to be identified on the labeling?
(MD/IVD) Yes, the Egyptian commercial partner (ERH/importer) must be identified on the label.
Is e-labeling allowed?
(MD) Yes, the EDA accepts electronic IFUs (e-IFUs), as long as a paper copy can be provided within 7 calendar days upon request, which must be stated in the labeling submitted with the registration application.
(IVD) No, the EDA does not accept electronic IFUs (e-IFUs).
QMS
Are there specific QMS requirements for registration?
(MD) 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.
(IVD) Per Appendix IV and Appendix V of the Regulatory Rules for the Registration and Circulation of Laboratory and Diagnostic Reagents, the required QMS certification for registration and/or import approval of IVDs depends on the classification of the IVD in the leveraged reference market (i.e., the EU, US, or Canada).
Is an on-site QMS audit required?
(MD/IVD) No, an on-site QMS audit by the EDA is not required.
Testing
Is there any local testing or clinical trials required for registration?
(MD) Some devices may require testing at the National Organization for Drug Control and Research (NODCAR), which commonly requires the provision of six sterilized samples of the device to be tested.
(IVD) IVDs are recently subject for registration, though they must successfully pass random sampling after release from Customs in order to be sold in Egypt.
Post Approval
Renewals
How long is the registration valid?
(MD) The medical device registration is valid for 10 years.
(IVD) IVD registrations will be valid for 5 years, once implemented.
How soon can/should registration renewals be initiated?
(MD) Emergo recommends beginning the renewal process 6–8 months prior to the expiration date, and submitting at least 30 days prior to expiration.
Renewal is dependent on a statement from the manufacturer declaring that there have been no changes in the device since initial registration and furnishing updated certificates (e.g., ISO 13485, CE Marking Certificate, CFS, etc.).
If there are multiple changes or changes that affect the performance of the device, a new registration may be required. Thus, it is advisable to consult with the ERH in advance to avoid any lapse in the registration.
(IVD) Mandatory implementation of registration for IVDs is currently ongoing, and thus there is no practical experience with the renewal process at this time.
How long do registration renewals take to obtain approval?
(MD) Processing of renewals is expected to take an average of 3-4 months. With that said, Fast Track is available as an option to expedite the review timeline for renewals (or modifications).
(IVD) Mandatory implementation of registration for IVDs is currently ongoing, and thus there is no practical experience with the renewal process at this time.
Can a device be sold while the registration renewal is in progress?
(MD) Yes, the EDA allows importation for 1 full year after expiration as long as the renewal has been submitted.
(IVD) Mandatory implementation of registration for IVDs is currently ongoing, and thus there is no practical experience with the renewal process at this time.
Importation
What certifications/authorizations must be obtained prior to importation?
(MD) All devices require registration with the EDA prior to importation, unless they are in an exempt category. However, as long as the application has been submitted by the ERH, the EDA may authorize importations of devices that are neither implantable nor provided in sterile condition in the interim. Additionally, all devices require the manufacturer and device(s) to be listed on the ERH/importer’s Importation Record at the EDA, and the ERH/importer must also obtain an Import Permit.
(IVD) Mandatory registration of IVDs is currently being phased-in, per the device classification. Egyptian IVD manufacturers were required to submit the registration by July 1, 2021. Foreign manufacturers must submit the registration by July 1, 2022 for List A or List B IVDs (or equivalent) or January 1, 2023 for General/Other or Self-Testing IVDs (or equivalent). Additionally, all IVDs require the manufacturer and device(s) to be listed on the ERH/importer’s Importation Record at the EDA, and the ERH/importer must also obtain an Import Permit.
Can the manufacturer ship the product directly to the end user/customer?
(MD/IVD) No, an importer is needed to clear the devices through Customs. Further, for devices subject to registration, the EDA has limited the right to importation to the local applicant for registration (ERH) in order to better control vigilance reporting activities.
Does a registration transfer require the registration “holders” approval?
(MD) Yes, a transfer requires approval from the current ERH. However, it is also possible for the new ERH to instead obtain their own registration if the transfer is not possible.
(IVD) Mandatory implementation of registration for IVDs is currently ongoing, and thus there is no practical experience with the transfer process at this time.
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