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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

Medical device regulatory guidelines
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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.

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Drug Services

THERAPEUTIC AND COSMETIC APPROVAL

ARQon provides therapeutic and cosmetic approval for Drug, Cell Tissue, Traditional Medicine, Health Supplements and Cosmetic in Egypt.

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Health Safety

WIRELESS, RADIATION AND PACKAGING APPROVAL

ARQon provides Wireless, Radiation, Packaging and Non-medical Device Approval in Egypt.

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