Iran
Iran is a growing market for medical devices, with increasing demand for imports driven by the development of the healthcare sector.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The competent authority is the Iranian Food and Drug Administration (IFDA).
Device Classification:
- Class A: Low risk
- Class B: Moderate risk
- Class C: High risk
- Class D: Very high risk
Specific Local Requirements
| Language | Documentation in Persian. |
| Local Representative | Mandatory for foreign manufacturers. |
| Certifications | CE, FDA, and ISO 13485 facilitate the process. |
Challenges and Operational Advice
- International sanctions: Possible export restrictions.
- Slow administrative process: Advance planning is necessary.
Why Choose ISEMED
- Emerging Markets Expertise
Assistance with registration and market entry strategies. - Regulatory Management
Support in preparing documentation for IFDA.
FAQ
- Is a local representative required? Yes.
- Documentation language? Persian.
- License duration? 5 years.