Medical device classification
We assign the correct device class based on intended use and risk, which defines the documentation and registration route.
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.
We determine how the Ministry of Health and Prevention will treat your product, then set the pathway to registration.
We assign the correct device class based on intended use and risk, which defines the documentation and registration route.
We categorise medicines and pharmaceutical products so the registration requirements and evidence are clear before you file.
For products that sit between categories, we clarify how they should be treated to prevent submission errors.
Once classified, we map the exact route and documents.
Product registrationThe 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.
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).
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.
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.
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.
Send us the product details and we will confirm the category and next steps.