UAE: Regulatory Process for Medical Devices

Medical devices must obtain marketing authorization before they are placed on the UAE market. Under the current federal framework, medical devices are regulated by the Emirates Drug Establishment (EDE), which is the UAE’s primary federal authority for medical devices and related health technologies.

Start by confirming product classification and whether EDE registration is required. EDE offers a product classification service to determine the governing regulatory pathway and whether the product requires medical device registration in the UAE. The classification letter is a preliminary classification only and is not a marketing authorization certificate.

Step 1: Obtain a product classification decision, if needed

Use EDE’s classification service to determine:

• whether the product is regulated as a medical device in the UAE
• the applicable class
• whether registration is required through EDE

The classification letter is valid for 3 years and does not by itself authorize marketing.

Step 2: Ensure the local applicant is properly licensed

For medical device marketing authorization, the applicant must be a medical warehouse or marketing office licensed by EDE and hold a valid license. The service page also states that the Marketing Authorization Holder company must be registered by EDE before it can register products.

Step 3: Prepare the marketing authorization dossier

The EDE service for issuing marketing authorization for a medical device lists documents including:

• signed and stamped registration application
• valid manufacturer registration certificate
• legalized Free Sale Certificate / registration certificate from the country of origin
• agency agreement or authorization letter between the company and the agent
• quality / marketing authorization evidence such as EC, 510(k), or PMA depending on class
• post market surveillance requirements
• copies of registrations in other countries
• safety and effectiveness data for Class III and IV devices
• special conformity documentation for certain products such as those involving animal derivatives

Step 4: Submit the marketing authorization application to EDE

The licensed local applicant submits the medical device marketing authorization application through EDE’s portal and pays the applicable fees.

Step 5: EDE reviews the application

EDE reviews the application based on the submitted dossier and applicable class-based evidence requirements. For higher-risk devices, the service requirements explicitly call for safety and effectiveness data for Class III and IV devices.

Step 6: Marketing authorization issued

If approved, the device receives UAE marketing authorization. Under the 2024 federal decree-law, marketing approval is valid for 5 years and is renewable.

Final Step: Maintain authorization and ongoing compliance

The 2024 decree-law requires the applicant to implement:

• a quality assurance system
• a product traceability system
• post-marketing follow-up

The law also empowers EDE to suspend or cancel approvals in cases such as unsafe products, non-compliance with approved quality standards, or submission of forged/incorrect information.

We Turn Your International Approvals Into UAE Market Access. MOHAP requires a Certificate of Free Sale or equivalent approval from your country of origin as part of every submission. Qaralogic builds your UAE registration package around the regulatory work you’ve already done FDA, CE Mark, Health Canada to get you to market without starting from scratch.