Medical Device Registration in the United Arab Emirates
Medical Device Registration
Qserve’s experts guide manufacturers through the medical device registration process in the UAE, ensuring compliance with the Ministry of Health and Prevention (MOHAP) regulations.
The United Arab Emirates (UAE) is a key entry point into the Middle Eastern healthcare market. To ensure patient safety and product effectiveness, all medical devices must be registered with MOHAP under the Drug Control Department (DCD) before being marketed in the UAE.
Qserve’s regulatory experts support manufacturers in navigating compliance requirements, documentation preparation, and regulatory approvals to facilitate a smooth market entry into the UAE.
GO-TO-MARKET STRATEGY AND REGISTRATION SUPPORT
Do you need assistance with medical device registration in the UAE or a go-to-market strategy?
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How Qserve Supports Your UAE Market Access
UAE Market Access
Qserve’s regulatory experts help manufacturers navigate the UAE’s complex regulatory landscape, ensuring a smooth and efficient registration process. We offer:
- Regulatory Strategy & Compliance Guidance: We develop a clear go-to-market plan outlining the optimal path to compliance and registration.
- Medical Device & IVD Registration Support: We prepare and submit registration applications to MOHAP, ensuring fast approval.
- Authorized Representative (MAH) Services: We partner with a trusted UAE-based regulatory expert to act as your official Marketing Authorization Holder (MAH).
- Technical Documentation & Submission Package Preparation – Our team ensures your documentation meets UAE regulatory requirements, preventing delays.
- Gap Analysis & Risk Management: We assess your technical files, identify compliance gaps, and help correct deficiencies.
- Translation of Labels & IFUs: We ensure all labels and Instructions for Use (IFUs) comply with Arabic and English language requirements.
Qserve simplifies the UAE registration process by offering end-to-end regulatory support, from product classification to post-market surveillance.
Worldwide medical device and IVD registration
Why Choose Qserve?
- In-Depth UAE Regulatory Knowledge: Our specialists have extensive experience with MOHAP requirements and local registration procedures.
- Global Expertise, Local Support: With a strong international presence and local regulatory partners in the UAE, we streamline the compliance process.
- We anticipate regulatory challenges and help you avoid delays in UAE product approval.
- Comprehensive Regulatory & Quality Services: From ISO 13485 compliance to import licensing, we handle all aspects of medical device registration.
- Proven Success: We have helped numerous manufacturers achieve compliance and successfully expand into the UAE market.
Qserve ensures that your medical devices meet MOHAP regulations while minimizing regulatory burdens and approval timelines.
