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
The Egyptian regulatory system for medical devices is highly similar to the process in the European Union. Familiarity with the European Medical Devices Directives will help you meet device classification, quality system and other regulatory requirements in Egypt.
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.
Documents required for CAPA medical device registration
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
Please contact us for more information about registering a medical device in Egypt.