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