Classification of a Medical Product

about-the-service

This service allows the classification of products of all types and forms based on Presentation /Composition / Use and Design.

service-process

when-applying-through-the-website

• Log in using UAE PASS to start the service.
• Fill out the application form.
• Attach the required documents.
• Pay the fees.
• Submit the application.
• Issue the classification letter for a medical product.

conditions-and-requirements

• The purpose of the classification letter is to inform you of the laws governing your products within the United Arab Emirates.
• The classification letter determines the regulatory category of the product in terms of the requirement for registration with the Emirates Drug Authority. If the product is determined to require registration, it must be registered with the Ministry in accordance with the category specified in the classification letter.
• The classification is available to all types of companies and individuals.

required-documents

• Emirates ID or passport or trade license or drug store license (depends on the user type)
• Product catalogue for medical devices
• Product picture
• Certificate from the authorities in the country of origin related to the product (CPP/Free Sale Certificate/CE/ISO)
• Leaflet/product information in English/ Arabic
• Inner pack label with clear and readable product name and information (artwork)
• Outer pack label with clear and readable product name and information (artwork)
• Composition certificate (active/ inactive ingredient list with each ingredient quantity)/ MSDS (applicable for products containing medicinal/chemical ingredients)

faqs

• How do I select the appropriate account for product classification through the submission process?
• Agent (link with your existing account) - If you have a valid drug store license issued by UAE MOHAP licensing department, then select this account type.
• Other: Other authority licensed establishments, examples: Trade license, Free zone license etc. (establishment name and city should be similar to the trade license/ free zone license etc.).
• Individuals: If you don’t have any establishment license in UAE (applicant name should be similar to the Emirates ID/ Passport).
• How do I modify the account details?
• Fill or correct the user details: Go to top left corner of the screen - click on ‘account’ - settings - account details - fill/ correct information & press save button.
• How do I follow my application status?
• Check the dashboard frequently for comments from MOHAP officers.