The device pathway

Medical device registration, handled end to end.

A medical device cannot be imported, sold or used commercially in the UAE until the regulatory work behind it is done. We run that work for you: classification, the registration dossier, authority submissions, import permits and the supply chain behind them, delivered by the group that does this every day.

Plan your registration See how the pathway works

Run by our parent firm Pharmareg UAE's regulatory team. Device registration is the group's home ground, not an add on. Timelines depend on device class and authority response times.

Precision medical instruments on a dark surface
Regulatory home groundvia Pharmareg UAE
Working directly with
Dubai Health Authority UAE Ministry of Health and Prevention Emirates Drug Establishment NABIDH health information exchange
What you get

Every step from factory to UAE market.

Not advice about the pathway. The pathway itself, run for you end to end.

Classification

Each device assessed case by case against the current authority rules, settling its class and pathway before anything is filed.

Authorised representation

Local representation for overseas manufacturers, handled within the group, so you can register without first building a UAE entity.

Registration dossier

The technical file compiled, gaps closed and the submission prepared to pass review the first time.

Authority submissions

Filings and liaison handled start to finish, with every query answered by the team that built the dossier.

Import permits

Permits secured and importation run under our parent firm's own importer credentials.

Storage and supply

GDP compliant storage and onward distribution through the group's own licensed chain.

The compliant pathway

How a device legally reaches the UAE market.

Four gates, in order. We take your device through all of them.

01

Classified

The device's class and pathway settled with the authority rules before anything moves.

02

Represented

A local authorised representative in place, handled within the group.

03

Registered

Dossier submitted, queries answered, approval issued.

04

Imported and supplied

Brought in under the group's licences and moved through a compliant chain.

The engagement

Four phases to market.

Portfolio first, then dossiers, then the authority, then supply.

01

Portfolio review

Your device range assessed and classified, with a written pathway and document list per product before any work is committed.

02

Dossier build

Technical files compiled and gaps resolved with the manufacturer, prepared against the authority's current checklists.

03

Submission and liaison

Filings made and every authority query handled until approval, with progress visible to you throughout.

04

Approval and import

Permits secured, first shipments imported under the group's licences and placed into compliant storage. Timelines depend on device class and authority response times.

FAQ

Device manufacturers ask us.

Do all medical devices need registration in the UAE?+
Device requirements follow risk classification, and each product is assessed case by case against the current authority rules. Classification is the first step of every engagement, because it decides the pathway, the dossier and the timeline.
Do I need a local representative to register a device?+
Foreign manufacturers work through a local authorised representative. Our group acts in that role as part of the engagement, so overseas manufacturers can register and sell without first building a UAE entity.
How long does medical device registration take?+
It depends on the device class, the completeness of the technical file and authority processing times. A clean dossier submitted right the first time is the single biggest factor, which is why dossier preparation is where we spend the most care.
Can you import the devices once they are registered?+
Yes. Importation runs under our parent firm Pharmareg UAE's own importer credentials, with GDP compliant storage behind it, so registration flows straight into supply.
What about software and digital health products?+
Software based and digital health products are classified case by case like any other device. The classification outcome decides whether and how they are regulated, and we manage that assessment as the first step.
Does this connect to the clinic and telehealth builds?+
Directly. Clinics we build need their equipment compliant, and device brands often enter the UAE alongside a clinical operation. The registration work and the facility build run as one programme when both are needed.

Related reading: pharmaceutical product registration in the UAE and the pharmacy and supply chain build.

Register your devices.

One conversation, then a written roadmap: the classification, the dossier, the submissions and the timeline.

Start the conversation