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
No medical 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 Medical Device Registration in the UAE?
Any medical device sold, imported, or used in a UAE clinic must hold a valid market authorization first. 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 Emirates Drug Establishment, the EDE. It took over device authorization from MoHAP and now runs the UAE regulatory framework for devices through its portal at ede.gov.ae.
Registration confirms your device against its risk class, technical file, and quality system. Once approved, the device earns a marketing authorization valid for five years and can be sold across the country.
Classification
How Are Medical Devices Classified in the UAE?
The UAE uses the GHTF risk-based system. Your device class sets how deep the review goes and which documents you need, so the classification rules come first.
Unsure of Your Device Class?
Send us your device details and any CE or FDA approval. We will confirm the UAE class before you build the dossier, so your route is right from the start.
The Hard Gate
What Is a Local Authorized Representative?
Every foreign manufacturer must appoint a UAE-based Local Authorized Representative, the LAR, before a device can be registered. It is the gate that catches makers off guard.
- Your LAR is the UAE legal entity, also called the Marketing Authorization Holder
- It must hold a valid establishment licence and be 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 so you do not need a local entity
Paperwork
What Documents Do You Need for Device Registration ?
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 in the UAE
- 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 list against your class before filing.
Step by Step
How to Register a Medical Device in the UAE
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 establishment registration with the EDE. Products cannot be filed until this is approved.
Step 2
Classify the Device
Confirm the risk class from 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 the product application through ede.gov.ae using UAE PASS, attach documents, and pay the fees.
Step 5
Technical Committee Review
The EDE committee reviews the dossier and may issue deficiency letters needing a timely response.
Step 6
Marketing Authorization
On approval the device receives a marketing authorization valid for five years and 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.
In vitro diagnostic devices, the IVDs, register through the same EDE process but 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 equipment carries a second requirement. A CT scanner or dental X-ray needs its EDE 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 an EDE 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 on the 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. EDE product fee plus the application fee.
Establishment + Device
AED 15,000–16,000
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
Setting up the LAR establishment runs around AED 10,000 to 10,500 on its own.
Classification Letter
An official EDE classification letter is about AED 500 where the class is unclear.
Device 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 Device Registration 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
- EDE 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 is valid for 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, new indication, or manufacturing site change needs a separate variation application before the change takes effect.
Vigilance & 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 so your authorization stays valid and audit-ready year after year.
Get Started
Get Your Device Registered and Market-Ready in the UAE
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.