Egypt
Egypt is a growing market for medical devices, with high potential thanks to the modernization of the healthcare system.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The competent authority is the Egyptian Drug Authority (EDA).
Device Classification:
- Class I: Low risk
- Class IIa, IIb: Moderate risk
- Class III: High risk
Registration Process – Step by Step
| Phase | Estimated Timeframe | Required Documentation |
| Preparation | 3–6 months | Technical dossier, ISO 13485 certifications, clinical data |
| Submission | 2–4 months | Application submitted to EDA |
| Evaluation | 6–12 months | Documentation review, possible requests for clarification |
| Approval | 1–2 months | Registration certificate issued |
Specific Local Requirements
| Language | Documentation in Arabic or English. |
| Local Representative | Mandatory for foreign manufacturers. |
| Certifications | ISO 13485. CE, FDA, and Free Sale Certificate facilitate the process. |
Challenges and Operational Advice
- Bureaucratic process: Approval delays are possible.
- Evolving requirements: Regulations are subject to change.
Why Choose ISEMED
- Emerging Markets Expertise
Specialized support for the Egyptian market. - Comprehensive Assistance
Practical management from document submission to registration.
FAQ
- Is a local representative required? Yes.
- Documentation language? Arabic or English.
- License duration? 10 years.