The market is segmented by theproduct type, design, and end user. It is fused with many devices and havepresence of major players in the market such as Amecath, Medtronic, among others. The market is consolidated with many devices available and few players.
The market is expected to be driven by the factors such as increasing demand for antimicrobial coated catheters, product innovation, rising geriatric population coupled with high prevalence of chronic kidney diseases, rising shift towards developing products with high quality and to reduce the impact on patient’s safety, high adoption rate, improved and better reimbursement policies for renal therapies .
The market will be hindered because of the risk associated with the catheters. Medical devices are regulated bythe Central Administration for Pharmaceutical Affairs (CAPA), part of the EgyptianDrug Authority (EDA). Egypt has adopted the European Risk-based Classification System for medical devices. The timeframe for the registration process is eight months.
Licenses issued in Egypt are valid for ten years. The manufacturer emails Medical Device Department (MDD) asking for an appointment and wait for a response with meeting time. Within 20 working days, MDD schedules first interview with manufacturer. MDD will follow up after first review with further requests through email.In next 45 working days, MDD will start final review and send email with final requests (if applicable). Medical device registration approval is then issued.
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