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Global > Middle East >
Egypt
产品注册
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.
额外的RA/QA支持
MONTHLY REGULATORY SUPPORT FOR REGIONAL REGISTRATION
ARQon provide onsite/offsite monthly regulatory support for regional registration in Egypt.
药物服务
THERAPEUTIC AND COSMETIC APPROVAL
ARQon provides therapeutic and cosmetic approval for Drug, Cell Tissue, Traditional Medicine, Health Supplements and Cosmetic in Egypt.
健康安全
WIRELESS, RADIATION AND PACKAGING APPROVAL
ARQon provides Wireless, Radiation, Packaging and Non-medical Device Approval in Egypt.
