Oman
Oman is a niche but expanding market, with increasing imports of medical devices to support the development 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 Ministry of Health (MoH) – Directorate General of Pharmaceutical Affairs & Drug Control (DGPADC).
Device Classification:
- Class A: Low risk
- Class B, C: Moderate risk
- Class D: High risk
Specific Local Requirements
| Language | Documentation in English or Arabic.
|
| Local Representative | Required for foreign manufacturers. |
| Certifications | CE, FDA, ISO 13485, and Certificate of Free Sale are preferred. |
Challenges and Operational Advice
- Bureaucratic process: Possible delays due to document verification procedures.
- Local partner: Relying on an experienced local representative is essential.
Why Choose ISEMED
- Local Assistance
Support with document preparation and interaction with the MoH. - Experience in Gulf Markets
Specific expertise in the regulatory requirements of GCC countries.
FAQ
- Is a local representative required? Yes.
- Documentation language? English or Arabic.
- License duration? 5 years.