Egypt medical device QA/RA blog

News and commentary on regulatory changes.

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.

Egypt CAPA non-sterile/non-electrical medical device registration 2018According to Emergo consultants in Cairo, the Egyptian Central Administration of Pharmaceutical Affairs (CAPA) will extend registration requirements to disposable, 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, with the exception of dental products.

CAPA compliance timeframes

CAPA’s April 1st target is a hard deadline; Egyptian authorities will likely begin halting importations for disposable, 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:

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