Alpha is a Department of Health & ACTVET Approved, ISO 9001:2015 Certified Healthcare Management Consultancy

Product Classification

MOH medical product classification in the UAE

Every medical device and pharmaceutical product must be classified correctly before it can be registered and imported. Classification sets the regulatory category, the evidence you must provide and the registration pathway. Getting it right the first time avoids rejections, resubmissions and costly delays to market entry.

MOH medical product classification in the UAE
Correct categoryfrom the start
Faster entryfewer rejections
Devices & pharmafull product scope
MOHAP alignedUAE regulations
What we classify

The right category for every product

We determine how the Ministry of Health and Prevention will treat your product, then set the pathway to registration.

Medical device classification

We assign the correct device class based on intended use and risk, which defines the documentation and registration route.

Pharmaceutical classification

We categorise medicines and pharmaceutical products so the registration requirements and evidence are clear before you file.

Borderline & combination products

For products that sit between categories, we clarify how they should be treated to prevent submission errors.

Why it matters

Classification decides everything downstream

The category assigned to your product determines the technical file, labelling, testing evidence and timeline for registration with the Ministry of Health and Prevention. A misclassified product is a common cause of rejection and lost time. Our specialists confirm the classification up front so your registration moves cleanly to approval.

FAQ

Product classification questions, answered

What is medical product classification?

Product classification assigns the correct regulatory category to a medical device or pharmaceutical product before it can be registered and imported. The category sets the evidence you must provide and the registration pathway with the UAE Ministry of Health and Prevention (MOHAP).

Why does correct classification matter?

The category assigned to your product determines the technical file, labelling, testing evidence and registration timeline. A misclassified product is a common cause of rejection and lost time, so confirming the classification up front keeps your registration moving cleanly to approval.

Which products do you classify?

We classify medical devices by class based on intended use and risk, pharmaceutical products, and borderline or combination products that sit between categories and need clarification before submission.

What happens after my product is classified?

Once the category is confirmed, we map the exact registration route and the documents you need, so you can move to MOH product registration without resubmissions.

Not sure how your product is classified?

Send us the product details and we will confirm the category and next steps.

Classify my product