In Brief: Egypt Extends Registration Requirements for Non-sterile Medical Devices

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 only for sterile devices.

CAPA compliance timeframes

CAPA’s April 1^st 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.

Related Egyptian medical device regulatory information from Emergo:

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