Egypt

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Product Registration

MEDICAL DEVICE REGULATION IN EGYPT


Medical Device is regulated by the Central Administration for Pharmaceutical Affairs (CAPA) from the Egyptian Drug Authority (EDA) whose objective is to ensuring that the community has access to safe, effective affordable & secure products.


MEDICAL DEVICE REGISTRATION AND APPROVAL IN EGYPT


Medical devices are classified into 4 categories namely class I, IIa, IIb and III (I being the lowest risk and III being the highest risk) and is based on CE classification.


CE Marking for the Medical Device is highly recommended to get a registration approval from CAPA.

Example Of Approval

Source: CAPA

 
 
 
License Holding

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Extra RA/QA Support

MONTHLY REGULATORY SUPPORT FOR REGIONAL REGISTRATION

ARQon provide onsite/offsite monthly regulatory support for regional registration in Egypt.


Contact Us for more details.