Medical device registration in Dubai is an important process for manufacturers looking to bring their products to the market in the UAE. The UAE has a well-structured regulatory framework to ensure that only safe and effective medical devices reach the market. This guide will walk you through everything you need to know about registering medical devices in Dubai with the Ministry of Health and Prevention (MOHAP).
- What is Medical Device Registration in Dubai?
- Why Register Medical Devices in Dubai?
- Categories of Medical Device Registration in Dubai
- Medical Device Registration Process in Dubai
- Tips for a Successful Registration
- Key Considerations for Medical Device Registration in Dubai
- Requirements for Medical Device Registration in Dubai
- Benefits of Choosing Us for Medical Device Registration in Dubai
- Connect with Neeja Corporate Services
- Related Articles
What is Medical Device Registration in Dubai?
Medical device registration is when a medical device manufacturer obtains approval from the relevant regulatory authorities to market their products in a specific country or region. In Dubai, medical device registration is overseen by the Dubai Health Authority (DHA) and requires manufacturers to submit detailed documentation and evidence of the safety and efficacy of their products.
Why Register Medical Devices in Dubai?
The UAE is one of the fastest-growing healthcare markets in the Middle East. Dubai, in particular, is a hub for innovation and medical technology. Registering your device with MOHAP offers several benefits:
- Legal Market Access: Only registered devices can be imported, distributed, and sold in the UAE.
- Trust and Credibility: MOHAP registration signals that your device meets local safety and quality standards.
- Expansion Opportunities: Once registered in Dubai, you can expand across the GCC and MENA region.
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Categories of Medical Device Registration in Dubai
MOHAP classifies medical devices into the following risk categories:
- Class I – Low risk (e.g., bandages, thermometers)
- Class IIa – Low to medium risk (e.g., surgical gloves, syringes)
- Class IIb – Medium to high risk (e.g., infusion pumps, dental implants)
- Class III – High risk (e.g., pacemakers, heart valves)
The registration process and documentation requirements vary depending on the device class.
Medical Device Registration Process in Dubai
Here’s a step-by-step overview of the medical device registration process:
1. Appoint a Local Authorized Representative (LAR) – Foreign manufacturers must appoint a local authorized representative in the UAE to handle the registration process.
2. Prepare Required Documentation
Typical documents include:
- Free Sale Certificate (FSC)
- CE Certificate or FDA approval (if available)
- ISO 13485 certification
- Product labels and instructions for use
- Clinical evaluation reports
- Risk management documentation
3. Submit Application via MOHAP Portal – The LAR submits the registration application via the MOHAP online system, along with all required documents and fees.
4. Technical Review by MOHAP – MOHAP reviews the application for compliance with UAE regulations. Additional documentation may be requested during this phase.
5. Approval and Registration Certificate – Once approved, a Medical Device Registration Certificate is issued, valid for 5 years.
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Tips for a Successful Registration
- Ensure all documents are legalized and attested.
- Use a knowledgeable LAR experienced with UAE regulations.
- Double-check device classifications and ensure correct labeling.
- Stay updated with any changes in MOHAP guidelines.
Key Considerations for Medical Device Registration in Dubai
When seeking medical device registration in Dubai, companies should consider the following key factors:
- Regulatory Requirements: Understanding the specific regulatory requirements for medical device registration in Dubai is critical to ensuring a smooth and successful registration process.
- Documentation: Companies must prepare and submit comprehensive documentation to support their registration application, including technical specifications, testing reports, and labeling information.
- Timelines: The registration process can vary in length, with some applications taking several months to complete. Companies should plan accordingly and be prepared for potential delays.
- Compliance: Ensuring compliance with local regulations and standards is essential for obtaining and maintaining medical device registration in Dubai. Companies must stay informed of any regulatory changes or updates that may impact their registration status.
Requirements for Medical Device Registration in Dubai
The registration of medical devices in Dubai requires thorough preparation and attention to detail. By ensuring that all the required documents are in order, manufacturers can expedite the registration process and bring their products to market more quickly.
- Manufacturer’s Authorization Letter: This document authorizes a representative to submit the registration application on behalf of the manufacturer. It should be notarized and legalized.
- Product Information: This includes details such as the device name, model number, intended use, and technical specifications.
- Certificate of Free Sale: A certificate issued by the manufacturer’s home country regulatory authority, confirming that the device is approved for sale.
- Quality Management System Certificate: Evidence of compliance with ISO 13485 or an equivalent quality management system.
- Device Classification: Information on the risk classification of the device according to the DHA classification criteria.
- Clinical Evaluation Report: For high-risk devices, a comprehensive report demonstrating the safety and efficacy of the device.
- Labeling and Instructions for Use: Clear and detailed labeling and instructions for use in English.
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Benefits of Choosing Us for Medical Device Registration in Dubai
When it comes to registering your medical device in Dubai, you want to ensure that you are working with a trusted and experienced partner. Our team has years of experience in assisting companies with the registration of their medical devices in Dubai and we are well-versed in the local regulatory requirements.
- Expertise: Our team has a deep understanding of the regulatory landscape in Dubai and can provide valuable insights and guidance throughout the registration process.
- Efficiency: We understand that time is of the essence when it comes to bringing a medical device to market. With our streamlined processes and expertise, we can help you expedite the registration process.
- Compliance: Ensuring compliance with local regulations is crucial for the successful registration of your medical device in Dubai. Our team will work closely with you to ensure that all requirements are met.
- Support: We are committed to providing excellent customer service and support throughout the registration process. From answering your questions to providing updates on the progress of your application, we are here to assist you every step of the way.
In conclusion, When it comes to medical device registration in Dubai, trust the experts. Our team has the experience, expertise, authority, and trust to ensure that your device is successfully registered and approved for sale in Dubai. Contact us today to get started on the registration process and take the first step towards bringing your device to market in Dubai.
Connect with Neeja Corporate Services
Are you looking to start your new company in Dubai but feeling overcome by the registration process? Don’t worry, you’re not alone. Setting up a business in a foreign country can be challenging, but with the right guidance and support, it doesn’t have to be a stressful experience. Neeja’s business setup services offer complete support and serve as a one-stop shop for company setup in Dubai. We provide a wide range of value-added services, including a successful Medical Device Registration in Dubai, UAE. The pharmaceutical manufacturing company in Dubai is leading the way in innovation, quality, and trust in the industry. Over the years, we have successfully advised many new entrepreneurs to make their business dreams a reality.
To book a free consultation, call on +971 43243031. You can also send a WhatsApp message at +971 50 465 2843. To connect over email, send us your query at incorp@neejacs.com.
