UAE Medical Device Registration
Medical devices include a wide variety of tools used for medical purposes, including lab equipment, surgical tools, monitoring equipment, therapeutic equipment, implants, and prosthetics. The UAE maintains a high local standard for medical device regulations to ensure quality and utility of the products. UAE medical device registrations are handled by Ministry of Health and Prevention (MOHAP). Devices are divided in four different categories.
Key reasons for Medical Device Registration in Dubai, UAE:
- It ensures compliance with UAE health regulations and laws
- Confirms product safety and efficacy for public use
- Mandatory for legal importation and distribution in Dubai
- Helps avoid legal penalties and customs clearance issues
- Enhances brand credibility and market competitiveness
Businesses cannot trade or manufacture medical devices without proper registration in the United Arab Emirates. The registration remains valid for five years. You need a Local Authorized Representative (LAR) to conduct dealings with MOHAP.
This guide walks you through everything you should know about registering your medical devices in Dubai. It will help you avoid any challenges and complications along the way and experience a smooth process.
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Medical Device Classification in the UAE
- Class I (Low Risk)
- Class IIa (Low to Moderate)
- Class IIb (Moderate to High )
- Class III (High Risk)
This category include simple medical devices like include bandages, stethoscopes, or thermometers. They are safe and easy to use. Only basic documents are needed for approval. They do not need lab tests or clinical trials.
This category features devices that are a bit more complex in nature. Examples are dental mirrors, blood pressure monitors, or small imaging tools. They need extra checks to make sure they are safe. Some technical documents and risk reports are required. They may also need testing data.
This category has more complex devices. Examples include surgical instruments or bone implants. They go inside the body or are used during operations. They need detailed safety reports and test results. Sometimes, clinical trial data is also needed.
These are the most critical medical devices e.g. pacemakers, heart valves, and ventilators. They are used to save or support life. These devices need strong proof that they are safe. Strict testing and clinical evidence are required for approval.
Steps to UAE Medical Device Registration
As the devices are classified based on their use and complexity, you have to determine which category your product belongs to.
Hire a local authorized representative that can conduct your dealings with the Ministry of Health and Prevention efficiently.
Prepare the documents required based on your product type. Ensure all the documents are complete and valid.
Register and submit the application to MOHOP. Provide all the information required and ensure that it is valid. Invalid or incomplete information can cause issues.
The authorities will review the application and evaluate the product based on their standards. The registration process can be between 4 to 6 weeks overall.
Upon acceptance, you will receive your certificate of registration, allowing you to trade, export, manufacture your product legally in Dubai.
Understanding Product Registration in Dubai
This holds especial importance for medical devices because a human life spends on such equipment. It is mandatory for businesses to get their products registered and tested.
Difference Between Mainland & Free Zone Online Business
- Mainland
- Free Zone
The mainland licenses are regulated by the Department of Economic Development (DED). It provides several benefits to online businesses. Here are some of the highlights:
- You can trade freely within the UAE market
- UAE residents and foreign investors can get government support
- Mainland partnerships may be better for the long term
Free zones are regulated by their own authority, offering many benefits to new e-commerce businesses in Dubai. Some of the highlights about free zone setup include:
- Free zones in Dubai offers 100% foreign ownership and tax benefits
- Limited to operating within the Free Zone
- License issued by Free Zone authority with simplified setup
Your Best Banking Options in the UAE
Emirates NBD
This bank started in 1963. Its one of Dubai’s oldest and largest banks. It leading in digital banking. Its strong local trust and wide service network give it a solid edge in both personal and business services.
RAKBANK
RAKBANK was founded in 1976 and focuses on helping individuals and small businesses. It offers both regular and system compliant to Islam. The bank’s strength is in simple services, e.g. fast opening, and easy loan access for startups and freelancers.
First Abu Dhabi Bank
FAB was founded in 2017 from a merger and is now the largest bank in the UAE. It offers strong financial support and global reach. FAB’s edge is in high-value services and safe, large-scale banking for professionals and growing businesses.
ADCB
Abu Dhabi Commercial Bank began in 1985. It is known for smart digital services. It focuses on saving time for users through applications and online tools. It has strong customer service and tech-based growth. Among the best for personal and corporate banking.
Emirates Islamic Bank
This bank started in 2004. It is known for blending laws of Islam with modern tools. It was the first shariah bank to launch WhatsApp banking. Its main strength is offering Shariah-compliant products with easy access and user-friendly digital support.
Benefits of Medical Device Registration in Dubai
Legal market access
Boosts brand trust
Customs clearance ease
Join local tenders
Avoids legal issues
Proves device safety
Increases sales reach
Builds credibility
Faster market entry
Regulatory approval
Medical Device Regulations & Requirements
- Devices must be safe and effective for their intended use
- Must be classified under MOHAP’s medical equipment categories (Class I, IIa, IIb, or III)
- Manufacturer must have a valid manufacturing license
- Foreign manufacturers must appoint a Local Authorized Representative (LAR) in the UAE
- The LAR must hold a valid license from MOHAP
- Only devices approved in the country of origin or other regulated markets are eligible
- Compliance with UAE medical equipment guidelines
- Arabic or bilingual labeling for products
- Renewal of registration every 5 years
- Post-market surveillance and reporting of adverse events
Required Documents for Medical Equipment registration
- Free Sale Certificate (FSC)
- ISO 13485 Quality Certificate
- Device technical file
- Product label and packaging
- Instructions for use (IFU)
- Risk assessment report
- Clinical evaluation data
- Manufacturer’s license copy
- Authorized Representative appointment letter
- Valid trade license of LAR
Required Documents for Businesses
- Valid trade license
- Commercial registration certificate
- Memorandum of Association (MOA)
- Emirates ID of all signatories
- Passports of all shareholders
- Proof of operating address
- Board resolution (if applicable)
Common Mistakes & Solutions When Opening a Mashreq Account
Wrong Account Choice
Mistake: Choosing an account that does not suit your needs can cause problems later.
Solution: Check account features and pick the right type (salary, savings, etc.).
Missing Documents
Mistake: Submitting incomplete or incorrect papers can delay your application.
Solution: Double-check all documents before applying. Ask the bank for a checklist.
Ignoring Online Option
Mistake: Not using Mashreq’s app may cause extra effort and time.
Solution: Try Mashreq NEO for fast and easy online account opening.
Low Balance Maintenance
Mistake: Not maintaining required balance can lead to fines (for some accounts).
Solution: Choose zero-balance salary account if you want to avoid this issue.
Delaying First Deposit
Mistake: Not making the first deposit on time may keep your account inactive.
Solution: Deposit the required amount soon after opening the account.
Common Mistakes in Registration Process &
Solutions
Downgrading the Quality
Mistake: Many companies choose to lower the standard of their devices to save costs. It’s a huge mistake.
Solution: Provide the best production possible and ensure it meets the standards of the UAE market.
Messing the Paperwork
Mistake: Owners unaware of the requirements often miss the paper work. They provide wrong, invalid or incomplete documents, etc.
Solution: Do thorough research on the required documents based on your device. It’s best to seek professional help for accuracy.
Providing invalid Information
Mistake: Owners often submit the wrong or invalid information. Some provide invalid trade license and others miss important information.
Solution: Provide the right and complete information. Ensure you submit it right or seek professional help to assure accuracy.
Common Mistakes in Registration Process & Solutions
Downgrading the Quality
Mistake: Many companies downgrade the standard of their products to save costs. It’s a huge mistake.
Solution: Provide the best production possible and ensure it meets the standards of the Dubai market.
Messing the Paperwork
Mistake: Owners unaware of the requirements often mismanage the paper work. They provide wrong, invalid or incomplete documents, etc.
Solution: Do thorough research on what documents you need to submit. It’s best to seek professional help for accuracy.
Providing invalid Information
Mistake: Owners make the mistake of submitting the wrong or invalid information. Some provide invalid trade license.
Solution: Providing the right and complete information is of most importance. Ensure you submit it right or seek professional help.
Register Your Products in Dubai with IBG in 4 Simple Steps
Book a Free Consultation
Consult with our experts to assess your product and registration needs.
We Handle the Documents
We prepare and review all required documents with complete accuracy.
Fast-Track Submission
Your application is submitted quickly through our direct links with authorities.
Get Your Certificate
Receive your certificate and start selling your product legally in the UAE.
Why Choose IBG Consultancy for registration in Dubai
The market for medical tools in the Emirate of Dubai is becoming competitive. Businesses in that sector have to ensure getting their products authorization right. Contact us today and get your product legalized with ease.
Frequently Asked Questions
Who can submit a registration application for healthcare tools in the United Arab Emirates?
Only an authorized representative in the UAE can handle the registration process on behalf of the device manufacturers. The representative must be licensed by the ministry and have a valid establishment setup.
What does the approval process involve for new entries into the UAE market?
Are there specific conditions and requirements to begin registering medical products?
What is the registration timeline for new product entry?
What are the essential documents for medical device filing?
Can foreign medical device manufacturers apply directly in the UAE?
How are products classified under the medical device registration process?
Are registration certificates permanent in the United Arab Emirates?
What is establishment registration and why is it needed for medical devices in the UAE?
What role does the Ministry of Health and Prevention (MOHAP) play?
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