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Medical Device Registration and Approval in Egypt

ANSWERED ON THIS PAGE:

  • Must we register our medical device in Egypt before putting it on the market?
  • Do we need home-country approval to sell our medical device in Egypt?
  • How long is our Egyptian medical device registration valid?

Registration and approval of medical devices in Egypt require compliance with the Central Administration of Pharmaceutical Affairs (CAPA), a division of the Egyptian Ministry of Health that oversees the country’s medical device market. From our office in Cairo, Emergo can assist medical device manufacturers during all phases of the registration process in order to obtain market approval in Egypt.

Egyptian CAPA medical device registration reviews

CAPA requires all sterile medical devices to be registered prior to commercialization. Medical devices must have prior market approval in the US, EU, Australia, Japan, Canada or New Zealand, and must obtain a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG) from the reference country prior to registration in Egypt. Further, either a CE Certificate or CFG from the US FDA is required for registration.

Non-sterile devices require importation approval rather than a full registration. However, voluntary registration may aid in the importation process. As your medical device regulatory consultant for Egypt, we can help you prepare all necessary documentation in order to register your device with the CAPA.

How to submit your medical device CAPA registration application in Egypt

To submit your device application, your in-country representative must make an appointment with CAPA. Due to backlogs, it can take six to 10 months to obtain this appointment. Companies should compile the device application in the meantime to ensure submission is ready once the appointment date arrives. Among the materials needed for a registration submission to Egyptian regulators are:

  • Proof of ISO 13485 quality system certification (for sterile products)
  • Certificate of Free Sale from the US, Canada, Europe, Australia or Japan
  • Description and intended use of your medical device
  • Declaration of Conformity certificate
  • Clinical data, test reports, and other data to support the safety and efficacy of the device, as required

We can assist with CAPA device registration in Egypt

From our office in Cairo, Emergo can help you complete the necessary steps to start selling your medical device in Egypt. Here’s how we can help:

  • Compile your technical file and registration submission to CAPA formatting requirements
  • Submit your documentation to the scientific committee for review, if needed
  • Assist and coordinate documentation translations, if required
  • Submit your documentation to your local representative
  • Assist with preparing responses to additional information requests from CAPA

Emergo’s global consulting team has extensive experience obtaining regulatory approval in markets worldwide. Let us help you expand your market reach to Egypt.

 

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Common Egypt device registration questions

How long does it take to get regulatory approval for our medical device in Egypt?

The final approval is issued approximately five months after the application has been submitted. In some cases, typically for novel devices, CAPA will require a Scientific Committee review of the device. This review will extend the registration timeline.

As a foreign manufacturer, do we need an in-country representative to sell our product in Egypt?

Yes. Foreign manufacturers are required to appoint a local entity who will submit and hold their registration certificates on their behalf. The local entity, known as an Egypt Registration Holder (ERH), must have a licensed Scientific Office in Egypt, at least one Egyptian citizen on staff, and have proper business licenses. Its greatly advised to hire an independent local agent than your local distributor to hold your license if you would like to have control on the registration for the next 10 years. If you will leave registration in the hands of your local commercial partner, then every time you need to change your distributor, you will need to re-register your product.