Mar 6, 2018
Egyptian medical device regulators plan to require registration for moderate- and high-risk non-sterile devices starting April 1, 2018.
According to Emergo consultants in Cairo, the Egyptian Central Administration of Pharmaceutical Affairs (CAPA) will extend registration requirements to non-sterile, non-electrical Class IIa, Class IIb and Class III devices. CAPA currently requires registration for sterile devices as well as for Class IIa, IIb and III disposable, non-sterile devices.
CAPA’s April 1st target is a hard deadline; Egyptian authorities will likely begin halting importations for non-sterile, non-electrical devices that have not registered as of that date.
Emergo will provide additional updates from Cairo as we learn them.
Egyptian medical device market regulators at the Central Administration of Pharmaceutical Affairs (CAPA) will soon require the latest version of the ISO 13485 standard for quality system compliance, Emergo Group’s Cairo office has learned.
The Central Administration for Pharmaceutical Affairs (CAPA), Egypt’s medical device market regulator, has published a list of approved reference countries that companies applying for market authorization in Egypt may leverage in their device registration efforts.