EMERGO SUMMARY OF KEY POINTS:

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

Egyptian medical device market regulators will begin requiring registration 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) has in essence nullified the agency’s previous plan announced earlier in 2018 to expand regulatory oversight only to some non-sterile devices. Now those registration requirements have been extended to all medical devices marketed in Egypt; currently, sterile devices fall under CAPA regulation while non-sterile devices require importation approval but not full registration.

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:

• Egyptian CAPA medical device registration consulting
• Egypt medical device strategy report
• Certificate of Free Sale (CFS) support for medical device exports