Iraq
Iraq is an emerging market with increasing needs for medical devices to support the reconstruction of the national healthcare system.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The competent authority is the Ministry of Health of Iraq (MOH).
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 Arabic. |
| Local Representative | Mandatory for foreign manufacturers. |
| Certifications | CE, FDA, Certificate of Free Sale, ISO 9001, and ISO 13485 facilitate the process. |
Challenges and Operational Advice
- Complex bureaucracy: Potential delays in approval timelines.
- Geopolitical risks: Possible trade restrictions and regulatory changes.
Why Choose ISEMED
- Emerging Markets Expertise
Targeted support for operating in complex environments. - Regulatory Support
Management of the registration process and compliance with MOH requirements.
FAQ
- Is a local representative required? Yes.
- Documentation language? Arabic.
- License duration? 5 years.