Medical Device Registration in UAE 

The UAE healthcare market is growing fast, and medical device companies are paying attention. With billions being spent on modern hospitals, advanced clinics, and medical tourism, the demand for safe and high-quality medical devices has never been higher.

From basic hospital supplies to advanced diagnostic machines, the UAE welcomes medical innovation from around the world. But there is one rule you cannot skip. Before any medical device can be imported, sold, or distributed, it must be approved by the government.

Medical device registration in UAE is not optional. It shields patients, maintains safety, and keeps the healthcare system intact and dependable. It may not look very easy, but it gets easier the more you explain the steps. 

This manual splits everything into simple terms. It enables manufacturers, importers and distributors to the medical device registration in UAE process, and do so accurately and confidently.

Why the UAE is an Exceptional Market for Medical Devices

The continual growth of the UAE’s population, together with its healthcare quality focus, is impressive. The government is investing billions to improve its hospitals and medical infrastructure. Medical tourism is increasing every year, resulting in more hospitals needing to upgrade their medical devices and needing to do so more frequently.

This includes:

• Diagnostic machines.
• Surgical tools.
• Monitoring equipment.
• Medical consumables.
• In vitro diagnostic products.

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

Who Regulates Medical Devices in the UAE?

Medical devices in the UAE are regulated at the federal level. This means one central authority controls approval across all emirates.

MOHAP Medical Device Registration: Essential Role of MOHAP

MOHAP has long been the official body responsible for:

• Approving medical devices before sale.
• Ensuring safety and quality standards.
• Regulating manufacturers and distributors.
• Monitoring products after approval.

Introduction of the Emirates Drug Establishment (EDE)

In recent years, many regulatory duties moved to the Emirates Drug Establishment (EDE). EDE medical device registration now acts as the leading platform for:

• Medical device registration.
• Pharmaceutical approvals.
• Ongoing product supervision.

Today, most medical device applications are handled through the EDE medical device portal system, even though MOHAP remains the supervising authority.

The Department That Reviews Your Medical Device

Within the federal system, a specialised department handles the technical work.

Department of Registration and Drug Control (DCD)

This department analyses each medical device for the following:

• Verification of technical documents.
• Analysis of clinical and safety information.
• Validation of device classification.
• Assessment of manufacturing locations.
• Final registration certificate issuance after medical device approval UAE.

This guarantees that only safe and approved devices enter the UAE market.

Role of Local Health Authorities in Dubai and Abu Dhabi

Many companies confuse federal and local authorities. It is essential to know the difference in the medical device registration Dubai.

Local health authorities do not register medical devices. Their role is limited to healthcare facilities.

Dubai Health Authority (DHA)

DHA licenses:

• Clinics.
• Hospitals.
• Medical professionals in Dubai.

Department of Health – Abu Dhabi (DoH)

DoH licenses:

• Healthcare facilities.
• Medical staff in Abu Dhabi.

Medical device registration Dubai itself remains under MOHAP and the EDE medical device portal for the entire UAE.

What Is Considered a Medical Device in the UAE?

In the UAE, a product is classified as a medical device based on its intended use, not its size or complexity.

If a product is used to support healthcare decisions or patient treatment, it is likely a medical device.

Official Definition of a Medical Device

A medical device includes any instrument, equipment, software, implant, or material used for:

• Diagnosing disease.
• Preventing illness or injury.
• Monitoring health conditions.
• Treating or managing medical problems.
• Supporting or replacing body functions.

Medical devices do not work mainly through chemical action in the body. This separates them from medicines.

Common Examples of Medical Devices

Medical devices range from simple to complex products.

Low-risk examples include:

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

Medium-risk examples include:

• Blood pressure monitors.
• Infusion pumps.
• Diagnostic imaging tools.

High-risk examples include:

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

Each category follows a different review level during registration.

What Are In Vitro Diagnostic (IVD) Devices?

IVD devices test samples taken from the human body. These samples include blood, urine, or tissue.

IVDs help doctors diagnose or monitor diseases without touching the patient directly.

Common IVD examples include:

• Blood glucose test kits.
• COVID-19 test kits.
• Infectious disease screening kits.
• Laboratory reagents and analysers.

IVDs follow a similar process to medical devices but use a separate classification system.

Medical Device Risk Classification in the UAE

The UAE uses a risk-based classification system. The higher the risk, the deeper the review.

Class I – Low Risk

These devices have minimal contact with the body.

Examples include:

• Stethoscopes.
• Manual wheelchairs.
• Bandages.
• Tongue depressors.

Many Class I devices follow a simplified listing process.

Class II – Moderate Risk

These devices are more complex or invasive for short periods.

Examples include:

• Ultrasound equipment.
• Infusion pumps.
• Surgical gloves.

This Class is often divided into IIa and IIb.

Class III – High Risk

These devices are invasive or used long-term.

Examples include:

• Orthopaedic implants.
• Hemodialysis machines.

They require a complete technical and safety review.

Class IV – Highest Risk

These devices support life or vital functions.

Examples include:

• Pacemakers.
• Heart valves.
• Neurological catheters.

They undergo the strictest review process.

IVD Classification System (Classes A to D)

IVDs are classified based on test result risk.

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

Correct classification is critical. It affects timelines, documents, and approval depth.

Who Must Register Medical Devices in the UAE?

Medical device registration is mandatory for all businesses involved in the supply chain.

This includes:

• Local manufacturers.
• International manufacturers.
• Importers and distributors.
• Medical equipment traders.
• Healthcare suppliers.
• IVD manufacturers and sellers.

Foreign manufacturers must appoint a Local Authorised Representative (LAR) in the UAE.

Step-by-Step Process of Medical Device Registration in UAE

The UAE medical device registration process is now handled mainly through the EDE medical device registration portal.

Step 1: Appoint a Local Authorised Representative

Foreign companies must appoint a UAE-based representative. This party handles all regulatory communication.

Step 2: Register the Manufacturing Site

The factory where the device is made must be approved first. This usually takes around 30 days.

Step 3: Confirm Medical Device Classification UAE

If unsure, companies can request official classification confirmation before applying.

Step 4: Prepare the Registration Dossier

This includes:

• Technical files.
• Safety certificates.
• Clinical data.
• Quality certifications.

Step 5: Submit the Application

The application is submitted online through the EDE medical device registration system.

Step 6: Technical Review

Experts review documents, risk levels, and safety data.

Step 7: Approval and Certificate Issuance

Once approved, a registration certificate is issued.

Step 8: Obtain Medical Device Import Permit UAE

A medical device import permit UAE is required before shipping products into the UAE.

Common Reasons Medical Device Applications Get Rejected in the UAE

Wrong Medical Device Classification UAE

If a device is placed in the wrong Class:

• The documents will not match the risk level.
• The review team may reject the application.
• The process may need to start again.

Incomplete Technical Files

Applications often fail when:

• Technical files are missing.
• Clinical data are unclear.
• Safety reports are incomplete.

Invalid Free Sale Certificate

Applications get rejected if:

• The certificate has expired.
• It is not legalised correctly.
• The product name does not match exactly.

No Local Authorised Representative in the UAE

Without a local representative:

• Authorities cannot communicate properly.
• Post-approval duties cannot be handled.
• The application will not move forward.

Labelling and Language Issues

Common labelling problems include:

• Missing Arabic language for home-use devices.
• Incorrect product name or model.
• Missing safety warnings or instructions.

Cost of Medical Device Registration in UAE

Government fees are standardised but charged per product.

Costs depend on:

• Device risk class.
• Product type.
• Application scope.

Additional professional service fees may apply.

Why Medical Device Registration Is Important

MOHAP medical device registration protects patients and businesses.

Key benefits include:

• Patient safety.
• Legal market access.
• Quality control.
• Trust with hospitals.
• Avoiding penalties.
• Long-term business growth.

Medical device approval in the UAE is necessary. Unregistered devices cannot be imported or sold.

Validity, Renewal, and Changes in the Medical Device Registration System

Registration Validity

A registration certificate is valid for five years.

High-risk devices require safety reports every two years.

Renewal Process

UAE medical device registration process renewal should start 3 to 6 months before expiry.

Required documents include:

• Existing certificate.
• Updated ISO certificates.
• Safety history summary.

Making Changes to a Registered Device

• Changes must be reported.
• Minor changes require notification.
• Significant changes require re-approval before sales continue.

Post-Approval Compliance Checklist for Medical Devices in the UAE

Post Market Surveillance Medical Devices UAE

This includes:

• Monitoring devices in the field.
• Analysing and responding to complaints from customers.
• Assessing and responding to safety feedback.

Reporting Deadlines for Adverse Events

Reporting rules include:

• Death or severe injury requires a report within 10 days.
• A threat to public health requires a report within 48 hours.
• A report for other safety problems is due in 30 days.

High-Risk Device PSUR (Periodic Safety Update Report) Requirements 

Every two (2) years, a PSUT must be submitted. The PSUR must contain a global safety summary and safety report.

Documenting and Maintaining the Following Records:

• Sales and Distribution Records.
• Complaints Records.
• Incident Reports.
• Records of Changes.
• History of Changes.
• History of Compliance.
• Documents.

Renewing Your Medical Device Registration

Medical Device Registration is valid for 5 years. 

Best practice: 

• Begin the renewal 3 to 6 months in advance.
• Update all compliance certificates.
• Update all compliance documents.

UAE Medical Device Registration Changes for 2026 and After

Expected Changes to the EDE System:

• Improved digital tracking.
• Improved online monitoring.
• Reduced document processing times.
• Improved updates on approval and document status.

Improved Digital Monitoring and Digital Tracking

• Digital monitoring of compliance and tracking of applications is being improved. 

Automated compliance tracking

• Automated reminders.

Post Market Surveillance Medical Devices UAE (High-Risk)

• More detailed.
• Increased frequency of safety evaluation.
• Increased safety reporting.

Increased monitoring of the market

Manufacturers Are Likely to Experience:

• Improved review times.
• Reduced request for clarification.

For more in-depth guidance, consult the team of Business setup experts in Dubai. They are the top professionals and business setup consultants in Dubai with an experience of over 12+ years. They always welcome you for consultations and services of Business setup in Dubai.

Frequently Asked Questions

Q1: Is medical device registration valid for all emirates in the UAE?

Absolutely. You can get registered for medical devices in the UAE federally through the MOHAP and EDE system. Once you get approval, you can sell and import it in all of the emirates, including Dubai and Abu Dhabi.

Q2: What if my device has EU or US approval, but has not been registered in the UAE?

An FDA approval or a CE mark does not equate to sellability in the UAE. These approvals do not substitute for an EDE medical device registration to be completed.

Q3: Is it permitted to start marketing the medical device while waiting for approval from the UAE?

It is illegal. Once you start marketing the medical device, it becomes illegal to import or distribute it. You need a medical device import permit for the UAE to do that, even for product samples. Promoting unregistered devices leads to penalties and fines.

Q4: Do approved packaging and labelling changes impact my registration? 

Yes. Any change requiring labelling, packaging, or instruction updates must be reassessed. While some changes may only need a notification, others may need significant changes that require a new approval. 

Q5: What is the most significant compliance risk after getting a medical device approved in the UAE? 

The most significant risk is ignoring the post-market surveillance medical devices UAE regulation. Reporting and PSUR report submission delays are common and lead to license suspension, recall of the product, and, in some cases, a perpetual ban on the market. 

Final Thoughts: Getting Started the Right Way 

It is possible to register medical devices in the UAE strategically. With the proper steps, Civil Planning and the appropriate consultancy, the process can be as easy as possible. 

Being compliant is the best way to keep your patients safe, earn their trust, and grow your business in the healthcare industry in the UAE. 

Disclaimer: 

The information is intended for general guidance only. Regulatory changes may take place. Before taking actions to ensure your compliance, consult with appropriate authorities or regulatory professionals.

Contact Business setup experts in Dubai for a smooth medical device registration process!