Egypt Medical Device Strategy Report
Medical devices are regulated by the Medical Device Department of the Central Administration of Pharmaceutical Affairs (CAPA). Regulatory controls differ by device type, with only certain types subject to mandatory registration (sterile devices), while others can be voluntarily registered.
European CE Marking or proof of FDA clearance or approval is required for Egyptian market entry.
Let Emergo assist you in evaluating the Egyptian medical device regulatory framework as it applies to your device(s).
Through our global network of consultants, regulatory resources, and industry contacts, Emergo can provide incisive analysis of medical device markets, including Egypt.
Our Regulatory Pathway service for the Egyptian medical device market provides information such as:
- CAPA Regulatory Background
- Product Assessment and Device Classification Based on CAPA Rules
- In-Country Representation in Egypt
- Medical Device Registration Requirements
- Costs and Timeframes
- Labeling and Language Requirements
- Regulatory Roadmap for Egypt
- Post-Market Requirements