Your Trusted Regulatory Partner for Success in UAE
Engaging with MOHAP
Flexible regulatory terms, tailored regulatory intelligence, and local representation in UAE for seamless compliance and market access
OMC Medical UAE – Your Gateway to Regulatory Success
At OMC Medical, we specialize in helping medical device manufacturers navigate the UAE’s stringent regulatory framework. With expertise in MOHAP registration, GCC compliance, and market access, we ensure a seamless approval process for your products. Whether you need support with product classification, local representation, quality assurance, clinical evaluation, or post-market surveillance, our dedicated team in the UAE provides comprehensive regulatory solutions. Trust OMC Medical to help you achieve compliance and successfully enter the growing UAE healthcare market.
OMC Benefits
- Expert Regulatory Support – In-depth knowledge of MOHAP and GCC compliance for seamless market entry.
- Local Representation – Act as your trusted regulatory representative in the UAE.
- End-to-End Compliance – Assistance with product classification, quality assurance, and regulatory submissions.
- Clinical & Post-Market Support – Ensuring safety, effectiveness, and regulatory adherence.
- Faster Market Access – Streamlined approvals and reduced time-to-market.
- Proven Industry Experience – Years of expertise in medical devices, pharmaceuticals, and cosmetics.
- Tailored Solutions – Customized strategies to meet UAE-specific regulatory requirements.
- Commitment to Excellence – Reliable, transparent, and efficient service delivery.
Discover tailored solutions across pharmaceuticals, life sciences, consumer goods, and more. Our expertise spans diverse industries, ensuring compliance and excellence. Explore innovative strategies and services to elevate your business in the competitive market
The UAE’s medical device and IVD market is strictly regulated by MOHAP, requiring full compliance for market approval. OMC Medical simplifies this process by providing expert assistance in MOHAP registration, local representation, supplier audits, QMS implementation, process validation, and regulatory documentation. Our services ensure smooth market entry, ongoing compliance, and a strong competitive position in the UAE’s rapidly growing healthcare sector
The UAE’s cosmetics market is regulated by MOHAP, requiring strict compliance for product registration, safety assessments, and labeling. OMC Medical streamlines this process by offering expert guidance in MOHAP approvals, local representation, supplier audits, and ongoing compliance management. We help brands navigate the UAE’s evolving cosmetic regulations, ensuring seamless market entry and long-term success.
The UAE’s pharmaceutical market is regulated by MOHAP, requiring strict compliance for drug registration, clinical trials, quality control, and post-market surveillance. OMC Medical simplifies this process by providing expert support in MOHAP approvals, local representation, GMP compliance, supplier audits, and regulatory documentation. We help pharmaceutical companies navigate the UAE’s evolving regulatory landscape, ensuring smooth market entry and sustained compliance
OMC Medical provides expert support for businesses seeking market entry in the UAE by acting as an Authorized Representative and ensuring compliance with MOHAP regulations. We assist with regulatory submissions, appointing a local Representative, and managing communications with UAE authorities. Our expertise in the UAE’s evolving regulatory landscape ensures a smooth approval process, enabling seamless market access for medical devices, pharmaceuticals, and cosmetics. With OMC Medical, you gain a trusted partner to navigate complex compliance requirements efficiently
OMC Medical provides expert translation services tailored to the UAE’s regulatory landscape, ensuring compliance with MOHAP requirements. As an ISO 17100:2015 certified provider, we specialize in accurate translations of medical, pharmaceutical, and clinical documents, including IFUs, user manuals, and legal texts. Our services help businesses navigate regulatory approvals and facilitate seamless market entry in the UAE
About OMC
OMC Medical is a leading regulatory consulting firm specializing in global market access for medical devices, IVDs, pharmaceuticals, and cosmetics. With expertise in MOHAP regulations, we assist businesses in navigating the UAE’s complex compliance landscape, including product registration, quality assurance, local representation, and regulatory intelligence. Our tailored solutions ensure smooth approvals and seamless market entry, making OMC Medical a trusted partner for regulatory success in the UAE
We are a global firm and we have local expertise across the following countries.
Europe
Asia
Africa
Oceania
South America
North America
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Get Your Medical Device Approved in the UAE
The United Arab Emirates (UAE) has a well-structured regulatory framework to ensure the safety and efficacy of medical devices. If you are a manufacturer or distributor looking to enter the UAE market, understanding the approval process is essential
UAE Medical Device Registration & Compliance | Get MOHAP Approval Fast
Expand Your Medical Device Business in the UAE & GCC
Are you a medical device manufacturer looking to enter the UAE market?
Ensure your products meet UAE Medical Device Regulations and obtain MOHAP approval quickly with our expert assistance!
Before applying for approval, ensure your medical device meets the following requirements:
1: Classification of the Device
- The UAE follows a classification system similar to international regulatory authorities (Class I, II, III, and IV), based on the risk level of the device
- Higher-risk devices require more extensive documentation and compliance requirements
2: Appoint a Local Authorized Representative
- If you are a foreign manufacturer, you must appoint a UAE-based Local Authorized Representative (LAR) to manage the regulatory approval process
- The LAR must have a valid establishment license issued by MOHAP.
3: Compliance with International Standards
- Medical devices must comply with international safety standards such as ISO 13485 for quality management systems
- Devices already approved by major regulatory agencies (FDA, CE Mark, or Health Canada) are more likely to gain quick approval.
4: Technical Documentation
- Prepare a detailed technical file including the device description, intended use, design specifications, and risk assessment
- Clinical evaluation reports and test results may be required for higher-class devices.
5: Labelling and Instructions for Use
- Labelling must be in Arabic and/or English, including essential details such as device name, manufacturer information, intended use, and precautions
Once the key requirements are met, follow these steps to get your medical device approved in the UAE:
Step 1: Register the Local Authorized Representative (LAR)
The LAR must register with MOHAP and obtain an establishment license before proceeding with the device registration.
Step 2: Submit the Medical Device Registration Application
The LAR submits an online application to MOHAP, providing the necessary technical documents, compliance certificates, and proof of international approvals (if applicable).
Step 3: MOHAP Review and Evaluation
MOHAP evaluates the submitted documentation to verify compliance with UAE regulations. This process may take several weeks depending on the complexity of the device
Step 4: Payment of Fees and Approval Issuance
Once the device meets all regulatory requirements, MOHAP will issue the approval certificate. The manufacturer or distributor can then legally market and distribute the device in the UAE.
Getting difficulty in approval? Must Consult us
Why Register Your Medical Device in the UAE?
The United Arab Emirates (UAE) is a growing market for medical devices, offering:
- Access to the GCC & Middle East Markets
- MOHAP-Compliant Medical Device Registration
- Competitive Edge in the Healthcare Industry
- Regulatory Compliance & Market Legitimacy
📌 Without proper registration, your product cannot be legally sold in UAE
🚀 We help you obtain fast and hassle-free approvals
Required Documents for Registration
To register Medical Devices in UAE, you must submit:
- ISO 13485 Certification (Quality Management System)
- CE Marking or FDA Approval for Your Product
- MOHAP Medical Device Classification & Compliance Docs
- Clinical Trial Data & Risk Analysis Reports
- Authorized Representative Letter (for non-UAE manufacturers)
Don’t Have These Documents? We Can Help
Who Needs UAE Medical Device Registration?
- ISO 13485 Certification (Quality Management System)
- Distributors Looking to Import & Sell in the UAE
- Healthcare & Diagnostic Equipment Companies
- Medical Device Startups & Large Enterprises Expanding in UAE & GCC
Want to Sell in the UAE?
Product
Registration
Authorized Representative
Product
Classification
Technical
Document
Quality
Assurance
Post-Market Surveillance and Compliance
After approval, medical device manufacturers must ensure continued compliance with UAE regulations, including:
- Reporting any adverse events or recalls to MOHAP.
- Maintaining a quality management system.
- Renewing approvals before expiration.
Why Choose OMC Medical for UAE Medical Device Registration?
Navigating the UAE medical device registration process can be complex, but OMC Medical is here to help. We specialize in Medical Device Registration, Product Classification, Authorized Representation, and Quality Assurance, ensuring compliance with UAE regulatory requirements. Our expert team also supports Post Market Vigilance and Software as a Medical Device (SaMD) compliance, helping you maintain ongoing regulatory adherence. With a proven track record in the industry, we offer efficient solutions to guide you through the process.
Book your free consultation today and let us help you navigate the UAE medical device registration process with ease.
Frequently Asked Questions (FAQ)
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The approval timeline varies based on the complexity and classification of the device. On average, it can take between 4 to 6 months for MOHAP to review and approve a medical device.
Yes, all foreign manufacturers must appoint a UAE-based Local Authorized Representative (LAR) to handle regulatory submissions and communication with MOHAP.
In most cases, MOHAP accepts international certifications such as FDA, CE Mark, or Health Canada approval. However, some high-risk or novel devices may require additional testing or clinical data.
Medical device registration is typically valid for 5 years. After this period, renewal is required to continue selling the device in the UAE market
Yes, a distributor can apply for approval if they are registered as the Local Authorized Representative (LAR) and hold a valid MOHAP establishment license.
Manufacturers and LARs are required to report any adverse events or recalls to MOHAP immediately. Failure to comply with post-market surveillance requirements can lead to penalties or withdrawal of approval
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