You’ve got a medical device ready for the UAE market—everything from quality certifications to technical documentation is in place. But just as you start the registration process, the real challenge begins.
Suddenly, you’re navigating a sea of forms, portals, and changing regulations. The process feels unclear, the requirements keep shifting, and your timeline starts slipping.
Sound familiar? You’re not alone. Many manufacturers and importers face similar frustrations when dealing with UAE medical device registration.
Let’s walk through the most common challenges—and how to solve them.
Challenges in UAE Registration process
1. Dealing with One Main Authority – But Not Always Straightforward
In the UAE, the Ministry of Health and Prevention (MOHAP) is the central authority for medical device registration. Sounds simple, right? But here’s where it gets tricky.
Challenge
MOHAP handles federal-level registrations, but if your product is going into a free zone (like Dubai Healthcare City) or a specific emirate with its own internal policies, the requirements may shift slightly—or additional steps may pop up.
What to do
Don’t assume “one size fits all.” Make sure you understand where your product will be sold and if any local or free zone nuances apply. Talking to someone with experience can save you from unnecessary surprises.
2. Appointing a Local Authorized Representative (AR)
If you’re a foreign manufacturer, you can’t register your device directly with MOHAP. You need a UAE-based Authorized Representative (AR).
Challenge
Many companies rush into appointing an AR without understanding their role. But this person (or company) isn’t just a go-between—they’re legally responsible for your product in the UAE. That means they’ll deal with MOHAP, handle post-market duties, and hold key documents.
What to do
Choose a reliable AR who understands the process and can protect your business interests. At OMC Medical, we often act as ARs for our clients, so we know how crucial it is to do this right.
3. Document Requirements Are Strict—And Often Misunderstood
MOHAP requires a detailed set of documents, including the Free Sale Certificate (FSC), ISO 13485 certificate, risk analysis, clinical evaluation report, and more.
Challenge
Each document must meet very specific formatting and attestation rules. Even a small issue—like missing a stamp or having an expired FSC—can cause your application to be rejected or delayed.
What to do
Double-check everything before submission. Make sure all documents are in English (or officially translated), attested properly, and match MOHAP’s latest guidelines. Having a pre-submission review is a smart step.
4. Product Classification Can Delay Your Timeline
MOHAP classifies devices into different risk categories (Class I to Class III), and each class has its own level of scrutiny.
Challenge
If you don’t classify your product correctly, MOHAP may reclassify it—and that usually means starting over or submitting more documentation.
What to do
Review MOHAP’s classification guidelines closely, or work with someone who knows how to interpret them. Getting this step wrong is one of the most common—and avoidable—registration delays.
5. The Online System Isn’t Always User-Friendly
MOHAP uses an online portal for submissions, but many users find it confusing or glitchy, especially if it’s their first time navigating the system.
Challenge
Upload errors, unclear status updates, and submission formatting issues can cause frustration and slow down progress.
What to do
Familiarize yourself with the system layout, take screenshots of every step, and keep backup copies of every document. If you’re submitting for the first time, consider walking through the system with someone experienced.
6. No Fixed Timelines for Approval
Once you submit your application, MOHAP doesn’t commit to a specific turnaround time.
Challenge
You could hear back in two weeks—or two months. And if they raise any queries, your timeline gets pushed even further.
What to do
Build in buffer time when planning your UAE launch. Be prepared for back-and-forth, and respond to MOHAP queries quickly to avoid further delays.
7. Regulatory Updates Without Much Warning
UAE regulations are evolving, especially as the country aligns more closely with international standards.
Challenge
Changes to document formats, fees, or classification rules can come with little notice—and if you’re unaware, your application might suddenly fall short.
What to do
Stay connected with regulatory updates via MOHAP’s official portal or work with a consultant who tracks these changes. At OMC Medical, we keep our clients informed and help them adjust quickly when rules change.
Conclusion
The UAE registration process isn’t simple—but it’s manageable with the right preparation and support. Most delays and frustrations come from small missteps: a missing document, the wrong classification, or an unclear role for your local representative.
The good news? Every challenge has a solution. Whether you’re just starting out or stuck mid-process, OMC Medical can guide you through each step with clarity and confidence. We’ve helped companies across the globe navigate UAE regulations—and we can help you too.
Ready to move forward with fewer headaches?
Let’s talk. Our experts are here to simplify the process so you can focus on bringing your product to market.
