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, while others can be voluntarily registered.
Egyptian medical device regulations are based largely on European Union requirements. Except in the case of Class I non-sterile products, all medical devices must have proof of free sale in their countries of origin as part of the registration process in Egypt. In addition, 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 Global Regulatory Overview Report service for the Egyptian medical device market provides information such as:
- CAPA Regulatory Background
- Product Assessment
- Device Classification Based on CAPA Rules
- Authorized Representation in Egypt
- Medical Device Registration Requirements
- Costs and Timeframes
- Labeling and Language Requirements
- Regulatory Roadmap for Egypt
- Post-Market Requirements