Medical Device Registration in UAE Simple Guide 

The UAE is quickly becoming a global healthcare hub. New hospitals, smart clinics, and medical tourism are growing every year. This growth creates a strong need for safe and reliable medical devices.

From basic hospital tools to high-tech machines, the UAE welcomes innovation. But there is one rule every company must follow. No medical device can be sold, imported, or used without government approval.

Medical device registration in UAE is mandatory. The system safeguards the patients and the doctors and secures the system as well. It may seem difficult at first, but as with most things, if broken down into manageable steps, it can be made simple.

This will be the first time that we will be guiding you through the foreign medical device registration process. As such, we will explain everything as simply as possible to assist our manufacturers, importers, and distributors in compliance with the UAE medical device registration process.

The UAE Medical Device Market Potential

The UAE has one of the highest government spending on health care. New hospitals open every year. Existing clinics upgrade their equipment often. Medical tourists also visit the UAE for advanced treatments.

Because of this, hospitals and labs need:

• Diagnostic machines.
• Surgical instruments.
• Monitoring devices.
• Medical consumables.
• In vitro diagnostic (IVD) products.

For global medical device companies, this is a significant opportunity. But entry into the UAE market is only allowed after proper registration.

Who Controls Medical Device Approval UAE?

Medical devices are regulated at the federal level. This means one approval works across all emirates.

MOHAP Medical Device Registration: MOHAP’s Role in the Regulation of Medical Devices  

The Ministry of Health and Prevention (MOHAP) has the following responsibilities:  

• Device approvals  
• Establishing and implementing safety standards  
• Ensuring compliance with market regulations  
• Monitoring devices after approval  

Emirates Drug Establishment (EDE): Principal Platform for Applications  

Most applications are currently processed via the Emirates Drug Establishment (EDE) system.  

EDE oversees:  

• The registration of medical devices.  
• Reviews of applications are undertaken digitally.  
• Monitoring of products in the marketplace.  
• MOHAP continues to oversee the system, but EDE remains the primary online system used by companies.  

Which Department Assesses Your Medical Device?  

A dedicated technical team oversees each application.  

Department of Registration and Drug Control (DCD)  

This department evaluates the:  

• Technical documentation.
• Safety and clinical information.  
• Classification of the device. 
• Information about the manufacturing site.  
• Approval is granted exclusively to devices that satisfy all safety criteria.

Do Local Authorities Register Medical Devices?

No. This is a common misunderstanding.

What Dubai and Abu Dhabi Authorities Actually Do

• Dubai Health Authority (DHA) licenses hospitals and clinics in Dubai.
• Department of Health Abu Dhabi (DoH) licenses healthcare facilities and staff.

They do not approve medical devices.

Medical device registration remains federal through MOHAP Medical Device Registration and EDE.

What Counts as a Medical Device in the UAE?

A product is considered a medical device based on how it is used, not its size or complexity.

Official Meaning of a Medical Device

A medical device includes any product used to:

• Diagnose disease.
• Prevent illness.
• Monitor health.
• Treat medical conditions.
• Support body functions.

Medical devices do not work mainly through chemicals. This makes them different from medicines.

Labeling & IFU Requirements for Medical Devices in the UAE

Correct labeling is required for all medical devices sold in the UAE. Labels help users use devices safely.

General Labeling Rules

• The product name and model must be clear.
• The manufacturer’s name and address must be shown.
• A batch or serial number is required.
• Expiry date must be visible if applicable.

Language Requirements

• Professional-use devices: English is allowed.
• Home-use devices: Arabic language is mandatory.

Instructions for Use (IFU)

The IFU must include:

• Safe use steps.
• Warnings and precautions.
• Storage instructions.
• Cleaning and maintenance details.

Labeling mistakes are a common reason for rejection.

Common Types of Medical Devices in the UAE

Low-Risk Devices

• Bandages.
• Gloves.
• Syringes.
• Thermometers.

Medium-Risk Devices

• Blood pressure monitors.
• Infusion pumps.
• Imaging tools.

High-Risk Devices

• Surgical instruments.
• Implants.
• Pacemakers.
• Life-support systems.

Each risk level follows a different review process.

Understanding In Vitro Diagnostic (IVD) Devices

IVD devices test samples like blood or urine. They help doctors diagnose diseases without touching the patient.

Everyday IVD products include:

• Blood sugar test kits.
• COVID-19 test kits.
• Infection screening kits.
• Lab reagents.

IVDs follow a special classification system.

Medical Device Risk Classification in the UAE

The UAE uses a risk-based system. Higher risk means deeper review.

Class I – Low Risk

• Bandages.
• Tongue depressors.
• Manual wheelchairs.

Class II – Moderate Risk

• Ultrasound devices.
• Surgical gloves.
• Infusion pumps.

Class III – High Risk

• Implants.
• Dialysis machines.

Class IV – Very High Risk

• Pacemakers.
• Heart valves.

IVD Risk Classes

• Class A: Low risk.
• Class B: Medium risk.
• Class C: High individual risk.
• Class D: High public risk.

Correct classification is essential. A mistake can delay or reject approval.

Clinical Evidence Requirements by Risk Class

Clinical evidence proves that a medical device is safe and works as intended.

Clinical Data by Device Class

• Class I (Low Risk):

Basic safety data is usually enough.

• Class II (Moderate Risk):

A clinical evaluation report may be required.

• Class III (High Risk):

Strong clinical evidence is needed.

Includes clinical studies or published data.

• Class IV (Highest Risk):

Full clinical trials and long-term safety data are required.

Foreign clinical data may be accepted if it follows global standards.

Who Needs to Register Medical Devices in the UAE?

All parties involved in the sale or supply of the devices are mandated to register, including:

• Manufacturers.
• Importers.
• Distributors.
• Traders.
• Healthcare sector suppliers.

Foreign companies must appoint a Local Authorized Representative (LAR) in the UAE.

Medical Device Registration Process in the UAE

Step 1: Appointing a Local Authorized Representative

The representative should be located in the UAE and will be the primary contact with the regulators.

Step 2: Register Manufacturing Facility 

The factory must first be verified and approved. 

Step 3: Classification of Medical Device

If needed, firms can obtain a formal classification decision.

Step 4: Creation of the Registration Document

The following documentation must be prepared: 

Technical documentation

• Certification of the Device’s Safety.
• Clinical Evidence.
• Quality Documents.

Step 5: Submission of Registration Document

The document is submitted on the EDE medical device portal.

Step 6: Technical Assessment

Expert reviews of safety, risk, and compliance.

Step 7: Registration and Certificate Issuance

The final step in the process is receiving a Certificate of Registration.

Step 8: Submission of Medical Device Import Permit

A medical device Import Permit must be obtained before devices can be shipped to the UAE. 

Documents Needed to Register Medical Devices in the UAE

The first part of the process to register medical devices in the United Arab Emirates is the submission of documents to the authority. These documents ensure that the product is marketable and legally safe to sell.

Necessary Documentation

Free Sale Certificate (FSC)

Sells the device in the country of origin (home country).

ISO 13485 Certification

Certification stating that the manufacturer complies with the quality regulatory requirements.

Declaration of Conformity

Certification stating that the device complies with the required standards.

Technical File

Contains information on the device’s design, materials, and performance.

Clinical Evidence or Safety Data

Contains information to support that the device is safe and works as intended.

Product Label and Instructions for Use (IFU)

Must comply with UAE regulatory requirements.

Power of Attorney for Local Authorised Representative UAE Medical Devices

Authorizes a representative to act on behalf of the manufacturer in the UAE.

Trade License of UAE Distributor

Reasons for the Rejection of Medical Device Applications

Incorrect Medical Device Classification UAE

Providing the wrong class leads to a mismatch in document submission, resulting in an automatic rejection.

Missing or Weak Technical Files

Incomplete safety or clinical data causes delays.

Invalid Free Sale Certificate

Expired or mismatched certificates are not accepted.

No Local Authorised Representative

Without an LAR, the application cannot move forward.

Labeling Problems

Common issues include:

• Missing Arabic labels.
• Incorrect product names.
• Missing warnings.

Cost of Medical Device Registration in UAE

Costs depend on:

• Risk class
• Product type
• Number of devices

Government fees are charged per product. Professional service fees may apply.

Timeline: How Long Does Medical Device Registration Dubai Take?

The time needed for medical device registration Dubai depends on the device risk level and document quality.

Average Registration Timeline

• Manufacturing site approval: 20–30 working days.
• Low-risk devices (Class I): 2–4 weeks.
• Medium-risk devices (Class II): 1–2 months.
• High-risk devices (Class III & IV): 3–6 months.

What Can Cause Delays?

• Wrong Medical Device Classification UAE.
• Missing or unclear documents.
• Expired certificates.
• Delayed answers to authority questions.

Well-prepared files help speed up approval.

The Importance of Medical Device Registration in UAE

Registration guarantees:

• Safety of the patients.
• Access to the market legally.
• Reliability of hospitals.
• Quality of products.
• Sustainable business expansion.
• Devices that are not registered are barred from being marketed or imported.

Registration, Amendments, and Renewal

For How Long Is Registration Valid?

Registration is valid for 5 years.

High-risk devices are required to submit safety reports biannually.

When to Renew?

Renewal should start 3-6 months before the expiry date.

Post-Approval Changes

Minor changes require a notification.

Significant changes require a new approval.

Post-Approval Compliance of Medical Devices in the UAE

Post Market Surveillance Medical Devices UAE

Businesses are required to: 

• Evaluate product performance.
• Document and review consumer feedback.
• Address potential safety concerns.

Reporting Timelines for Adverse Events

• Serious injuries and deaths: 10 days.
• Public health concerns: 48 hours.
• All other incidents: 30 days.

Post-market surveillance for high-risk medical devices

High-risk medical devices are required to submit a Periodic Safety Update Report (PSUR) biannually.

Documentation Requirements

• Sales records.
• Log of consumer feedback.
• Documentation of incidents.
• History of changes.

2026 and Beyond: Adaptations of the UAE Medical Device Registration

Anticipated Changes

• Streamlined digital review process
• Improved review tracking
• Automated review status notifications

Increased Regulatory Oversight for High-Risk Devices

• Increased frequency of safety assessments
• Enhanced post market surveillance medical devices UAE
• Streamlined benefits for compliant manufacturers
• Quicker product approvals
• Streamlined requests for additional information
• Enhanced compliance transparency

The Consequences of Non-Compliance in the UAE

The UAE regulations on medical devices are strict to ensure public safety. Non-compliance can lead to significant consequences.

Consequences can include:

• Substantial monetary penalties
• Prohibition on the importation of medical devices
• Recalls of devices from the market
• Suspension or revocation of company licenses
• Blacklisting of products and/or companies

Significant violations include:

• Marketing devices that are not on the registry
• Failure to conduct post-market surveillance
• Not reporting adverse events
• Using labels that are not compliant or have expired
• Compliance ensures consumer safety and protects your business.

Our professional team from PRO Services in Dubai can help you in the process better. They are licensed business setup consultants in Dubaiwith over 12+ years of experience in providing PRO Services Dubai.

Frequently Asked Questions – Medical Device Registration in UAE

Q1: Can I register a medical device in the UAE without a local representative?

No. A Local Authorised Representative UAE medical devices (LAR) in the UAE is required for all foreign manufacturers. They handle communication and compliance with authorities.

Q2: Does FDA or CE approval count for UAE registration?

No. UAE registration is separate. FDA or CE approvals do not replace MOHAP/EDE medical device registration.

Q3: How often do high-risk devices need safety updates?

High-risk devices (Class III & IV) must submit a Periodic Safety Update Report (PSUR) every 2 years to show ongoing safety.

Q4: Can I sell a medical device before EDE approval?

No. Selling or importing unregistered devices is illegal and can lead to fines, recalls, or license suspension.

Q5: What is the fastest way to avoid registration delays?

Prepare complete technical files, correct classification, valid certificates, and appoint a UAE LAR. Complete submissions speed up approval.

Final Thoughts: Start the Right Way

In the UAE, registering a medical device is an integral part of doing business, and more importantly, it is the law. It is beneficial and protects the patients and the business in the long run.

Having a business set up in Dubai means you won’t make as many mistakes, and it helps you to remain compliant. Their 12 years of experience are beneficial for the smooth registration for peace of mind.

Contact PRO Services in Dubai for more help!