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Egypt’s CAPA Expaning Medical Device Registration Requirements

EMERGO SUMMARY OF KEY POINTS:

  • Egyptian regulators will require registration or listing for all medical devices starting in September 2018.
  • Currently only sterile devices fall under Egyptian CAPA oversight.

Egypt CAPA medical device regulatory expansion September 2018Egyptian medical device market regulators will begin requiring registration listing for all medical devices prior to commercialization starting September 1, 2018.

According to Emergo consultants in Cairo, the Egyptian Central Administration of Pharmaceutical Affairs (CAPA) now requires full registration for all sterile devices as well as non-sterile disposable Class IIa, IIb and III devices other than products specficially exempted by the regulator. All other devices are now subject to a "listing" process that used to be voluntary but is now mandatory. 

CAPA medical device registration requirements

CAPA has yet to provide full details on its new registration requirements, but affected manufacturers should be aware of the following points based on Emergo consultants’ analysis of available information:

  • To register, manufacturers will have to request appointments with CAPA to review their Technical Files (this requirement is already in place for sterile device manufacturers that must register with CAPA).
  • Importers currently authorized to operate in Egypt must request appointments with CAPA by August 2018 in order to continue legal operations in the country.
  • Sterile, single-use device accessories that have received approval via Scientific Committees will have to undergo registration along with their main devices starting in September 2018.
  • Specific Technical File content requirements will be published on CAPA’s website.

Additional details on CAPA registration for all devices should become available prior to the September 1 2018 deadline.

Related Egyptian medical device market information from Emergo:

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