Class I: Low Risk
Non-invasive devices with little body contact, such as bandages, stethoscopes, and exam gloves.
RiskLow
CE matchCE Class I
ReviewSimplified
Medical Device Registration in the UAE: EDE Market Authorization
No device can be imported, sold, or used in a UAE clinic until it is registered with the Emirates Drug Establishment. We classify your device, act as your representative, and take it through to market authorization.
Excellent
15+ Years in UAE Compliance
Can Act as Your LAR
Classification & Dossier
Excellent
What It Means
What Is UAE Medical Device Registration?
Medical devices used in clinics, or imported and distributed in the UAE, must be registered and hold a valid market authorization first. Registration is mandatory, selling an unregistered device is illegal, and customs will hold the shipment at the border.
Since the end of 2025, this is handled by the EDE, which regulates medical products, including medical devices. It took over from the Ministry of Health and Prevention (MoHAP), and devices already registered with MoHAP keep their MoHAP medical device registration until it expires.
Registration confirms your device against its risk class, technical file, and quality system. Once approved, the device earns a medical device registration certificate valid for five years and can be sold across the UAE medical device market.
Classification
How Does the UAE Medical Device Classification System Work?
The UAE uses the GHTF risk-based system, which closely tracks the rules of the EU medical device directives. Your class sets how deep the review goes and which documents you need, so getting it right comes first.
Not Sure Which Class Applies?
Send us your medical device or IVD details and any CE or FDA approval. We will confirm whether the product requires registration and its class before you build the dossier, so your route is right from the start.
The Hard Gate
What Is a Local Authorized Representative in the UAE?
Every foreign manufacturer must appoint a UAE-based Local Authorized Representative, the LAR, prior to the registration of their products. It is the gate that catches makers off guard.
- Your LAR is the local legal entity, also called the Marketing Authorization Holder
- It must be a licensed medical warehouse or marketing office registered with the EDE first
- It submits the registration dossier and handles all regulatory communication
- It carries responsibility for the device once it is on the market
- Riz & Mona Consultancy can act as your LAR in the UAE to handle the registration, so you do not need a local entity
Paperwork
What Documents Do You Need for Medical Device Registration in UAE?
Two stacks carry every device file. One sets up the establishment that legally holds the registration. The other is the technical file that proves the device is safe, conforms to standard, and matches its class.
Establishment & Licence
- LAR establishment licence
- Foreign manufacturer registration details
- Free sale certificate, embassy attested
- Signed agency or agent contract
- Authorization letter from the manufacturer
Technical File
- ISO 13485 or quality management certificate
- CE, 510(k), or PMA conformity for the class
- Technical documentation and device description
- Instructions for use in Arabic and English
- Safety and efficacy data for Class III and IV
- Product sample and Certificate of Analysis
Higher-risk devices in Class III and IV need clinical evidence and deeper technical documentation review. We confirm the exact registration requirements for your class before filing.
Step by Step
How to Register a Medical Device in the UAE
The registration process in the UAE runs establishment first, then the product, in that order since the two steps run one after another, not at the same time.
Step 1
Register the Establishment
Your LAR completes site registration for the establishment. Products cannot be filed until this is approved.
Step 2
Classify the Device
Confirm the classification of the device from its intended use and body contact, mapping any CE or FDA approval to the UAE class.
Step 3
Prepare the Dossier
Build the technical file, conformity certificates, bilingual instructions, and class-specific safety data.
Step 4
Submit on the EDE Portal
File your application to register a medical device on the EDE portal using UAE PASS, attach documents, and pay the fees.
Step 5
Technical Committee Review
The technical committee reviews device registration applications and may issue deficiency letters needing a timely response.
Step 6
Marketing Authorization
On approval you receive a medical device registration with a five-year marketing authorization, and the device is listed for sale.
Special Cases
Do IVDs and Radiation Devices Follow Different Rules?
Two categories sit outside the standard path. Getting them wrong means a missing licence or the wrong class, so they are worth checking early.
Medical devices and IVDs (in vitro diagnostic devices) register through the same EDE process, but IVDs use their own risk system of Class A to D, based on the risk a wrong result poses. They also need performance and stability data.
Radiation-emitting medical equipment carries a second requirement. A CT scanner or dental X-ray needs its market authorization and, separately, a FANR practice licence for the facility operating it.
Standard ultrasound and MRI sit outside FANR scope. Confirming where your equipment falls before you buy or import avoids a device that is registered but cannot legally be switched on.
- IVDs use Class A to D, not I to IV
- IVDs need performance and stability data
- Point-of-care tests may need usability data
- X-ray and CT need a FANR practice licence
- Fluoroscopy and dental X-ray need FANR too
- MRI and ultrasound are outside FANR scope
Two Licences, Not One
A CT scanner needs both a market authorization to be sold and a separate FANR practice licence for the facility to legally operate it.
Pricing
How Much Does Medical Device Registration Cost?
Cost depends mostly on whether you already hold an establishment licence and varies depending on device class. The figures below are indicative ranges from current EDE fees, not fixed quotes.
Device Only
From AED 5,100
One device where the establishment is already registered. Product fee plus the application fee.
Establishment + Device
AED 15,000 to 16,000
A new setup needing establishment registration first, then the device registered on top.
High-Risk or Portfolio
Custom
Class III and IV devices needing clinical data, or several devices registered together.
What Moves the Price
Establishment
Site registration for the LAR establishment runs around AED 10,000 to 10,500 on its own.
Classification Letter
An official classification letter is about AED 500 where the class is unclear.
Risk Class
Class III and IV need clinical evidence, which adds preparation time and cost.
Attestation
Embassy attestation and legalization of origin certificates before submission.
A Note on Pricing
All costs shown are indicative and change with device class, establishment status, and EDE requirements. Riz & Mona Consultancy provides a personalized quote for your device before any work starts.
Typical Timeline
2–6
Months
Class I sits at the lower end. Class III and IV run longer with clinical data and committee review.
Heads up: The establishment must be approved before the product is filed, so the two stages add up. Preparing both in parallel where possible is the biggest time saver.
Timeline
How Long Does the Medical Device Registration Process Take?
Most device registrations land between two and six months. High-risk and professional-use devices can reach seven to eight as the dossier and review deepen.
- Establishment registration before any product
- Document preparation and embassy attestation
- Device classification and dossier build
- Portal submission and fee payment
- Technical committee review and deficiency letters
- Marketing authorization issued for five years
After Approval
What Happens After Your Device Is Registered ?
Renewals & Variations
A marketing authorization lasts five years. Renewal should start at least three months before expiry to avoid a gap that pulls the device off the market.
Any design change to a registered medical device, new indication, or manufacturing site change needs a separate variation application before the change takes effect.
Medical Device Regulatory Reporting
Devices carry ongoing duties. Adverse events must be reported within set timelines, and high-risk Class III and IV devices need periodic safety update reports.
Riz & Mona Consultancy manages this post-market compliance throughout the registration lifecycle, so your registration stays valid and audit-ready year after year.
Get Started
Get Your Device Registered and Ready for the UAE Market
Send us your device details and any CE or FDA approval. We will confirm the class, set up the representative, and take it through the EDE to a marketing authorization.
Free classification check•We can act as your LAR•Full EDE dossier handling•Personalized cost quote
Riz & Mona Consultancy provides a tailored quote based on your specific device, class, and establishment status.