Kuwait
Kuwait is a small but strategic market in the Gulf region, with growing demand for high-quality medical devices driven by state investments in healthcare.
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 (MoH) – Drug and Food Control.
Device Classification
There is no defined local classification, but the international system is accepted:
- Class I: Low risk
- Class IIa, IIb: Moderate risk
- Class III: High risk
Specific Local Requirements
| Language | Documentation in English or Arabic. |
| Local Representative | Required for foreign manufacturers. |
| Certifications | CE, FDA, and ISO 13485 are often required as a basis. |
Challenges and Operational Advice
- Variable timelines: Approval times may be subject to delays.
- Local relationships: It is essential to work with reliable and experienced distributors.
Why Choose ISEMED
- Gulf Region Expertise
Experience with the MoH and GCC markets. - Strategic Support
Assistance in all stages of registration and in managing relationships with local distributors.
FAQ
- Is a local representative required? Yes.
- Documentation language? English or Arabic.
- License duration? 5 years.