Medical Device Registration in the UAE
Placing a medical device on the UAE market
Bringing a medical device or IVD to the UAE means clearing strict federal checks before you can sell a single unit. We turn that complexity into a clear, managed pathway, whatever your device class.
From appointing your local representative to compiling the file and dealing with the authority, our specialists run the process end to end, so your device gets to market faster and with far less back-and-forth.
Medical devices we register
Every class and category of medical device and diagnostic, handled with the right pathway.
From classification to certificate
Appoint a Local Authorised Representative
A licensed UAE entity completes establishment registration with the authority and acts as your regulatory liaison.
Classify the device
Obtain a classification letter confirming the risk class and whether registration is required.
Build the technical file
Assemble ISO 13485 evidence, prior approvals, IFU, bilingual labels and a post-market surveillance plan.
Submit and review
File via the e-services platform; the technical committee evaluates the dossier and queries are resolved.
Certificate and import permit
A five-year registration is issued and an import permit is secured for customs clearance.
Product registration is what makes your product legal to sell in Dubai
Retailers will ask for approval
Major retailers, distributors, pharmacies and online marketplaces often require valid UAE product registration before they agree to list, stock or sell your product.
Customs clearance becomes easier
The right registration, permits, labels and product documents help reduce the risk of shipment holds, rejected imports and costly delays at UAE customs.
Your brand looks more credible
A registered product shows buyers, retailers and distributors that your product has been reviewed for compliance, labeling, safety and market readiness.
You can scale more products
Once your first product is registered, it becomes easier to launch additional SKUs, pack sizes, variants and product lines across Dubai and the wider UAE market.
UAE product registration support built for faster market entry
Dubai and UAE product classification
We identify whether your product requires Dubai Municipality registration, MOHAP approval, veterinary registration, cosmetic registration, food registration, supplement registration or another UAE authority pathway.
Registration documents reviewed properly
We check labels, certificates, formulas, ingredients, claims, product images, technical files and manufacturer documents before submission to reduce authority comments and avoid unnecessary delays.
Authority submission and follow-up
We manage the registration process with the relevant Dubai or UAE regulatory authority, including application preparation, submission, clarification responses and approval tracking.
Market entry support after approval
Once approved, we support import clearance, distributor onboarding, retail listing, online marketplace requirements, renewals, variations and additional SKU registrations.
Medical device registration FAQs
Do all medical devices need to be registered?
Can a foreign manufacturer register directly?
How are devices classified?
Is ISO 13485 required?
How long does registration take?
Ready to register your medical device?
From classification letters to LAR appointment and dossier submission, we manage the full pathway.