Understanding Oman Medical Device Registration and Approval
Oman is an emerging market for medical device manufacturers, offering opportunities for companies looking to expand their presence in the Middle East. Medical device registration in Oman is regulated by the Directorate General for Pharmaceutical Affairs and Drug Control (DGPA&DC) under the Ministry of Health (MoH).
If you’re planning to enter the Omani medical device market, understanding the regulatory requirements is crucial. In this guide, we’ll explore the registration process, classification system, and key regulatory considerations for medical devices in Oman.
Also, check out our service page on Medical Device Registration in Oman for detailed guidance and expert support.
Looking For a Medical Device Regulatory Consultant?
Let’s have a word about your next project
Overview of Medical Device Regulation in Oman
The DGPA&DC is responsible for regulating the approval and registration of medical devices in Oman. Currently, the system is under development, and the process follows a notification system rather than full-fledged registration.
The goal is to ensure that medical devices entering the Omani market meet safety and performance standards while facilitating a smoother regulatory pathway for manufacturers.
Medical Device Classification System
One of the advantages of registering medical devices in Oman is the flexibility in device classification. The DGPA&DC accepts all classification systems, meaning manufacturers can register their products based on internationally recognized frameworks.
This approach simplifies the registration process for manufacturers already obtaining approvals from other major regulatory bodies.
Medical Device Registration Process
Oman follows a notification system for medical devices, making the process faster and more efficient. Here’s a step-by-step breakdown:
- Prepare Documentation – Submit a dossier including product details, labeling, and compliance with international standards.
- Appoint an Authorized Representative – A local representative in Oman is required to handle regulatory communications.
- Submit Notification to DGPA&DC – The regulatory authority reviews the notification and verifies compliance.
- Approval & Market Entry – Once notified, the device can be marketed in Oman.
Timeframe: The notification process takes approximately 3-4 months, making Oman an attractive market for quick market entry.
License Validity and Renewal
Medical device licenses issued in Oman are valid for five years. After this period, manufacturers need to renew their license to continue selling their products in the country.
✔️ Tip: Start the renewal process at least six months before expiration to ensure a smooth transition.
Role of an Authorized Representative
A local authorized representative is mandatory for foreign manufacturers. This representative serves as the primary contact between the manufacturer and the DGPA&DC and is responsible for:
- Submitting registration documents
- Handling regulatory inquiries
- Ensuring post-market surveillance compliance
Conclusion
Medical device registration in Oman offers a fast-track market entry through its notification system, making it an attractive destination for manufacturers. However, staying informed about regulatory updates and compliance requirements is essential for long-term success.
If you’re planning to expand into the Omani market, partnering with an experienced regulatory consultant like Operon Strategist can help you navigate the approval process smoothly.
For Hassle-Free Medical Device Registration in Oman!
Expand Your Medical Device Business in Oman with Operon Strategist!
Looking to register your medical device in Oman? We’ve got you covered! Operon Strategist simplifies the entire process, helping you with documentation, approvals, and regulatory compliance. With our expert guidance, you can enter the Omani market smoothly and hassle-free.
Contact us today and let’s get your medical device approved in Oman—quickly and efficiently!