In August 2018, the Egyptian Regulatory Authority announced the extension of registration requirements for the placing of Medical Devices on the territory. Prior to this communication, only Class III devices, sterile single-use devices (regardless of the risk class) and all invasive devices were subject to registration. The reference risk classes of the Egyptian regulations are the same as those provided by MDR 93/42/EEC and s.m.i.
To date, the Central Administration of Pharmaceutical Affairs (CAPA) requires the registration of all Medical Devices, with the exception of non-sterile and in-vitro diagnostic Medical Devices.
To proceed with the registration of their devices, local manufacturers or local Legal Representatives (Egyptian Registration Holder – ERH) of foreign manufacturers must request (and obtain) an appointment in order to submit their applications for review to the Regulatory Authority.
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