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

• 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 & 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 marketing authorization with the Emirates Drug Establishment. If the product is determined to require marketing authorization, it must be registered with the EDE 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
• A certificate issued by the competent authority in the country of origin stating the product's status (Certificate of Pharmaceutical Product – Free Sale Certificate – ISO – CE). If the product is registered or marketed in other countries, please attach copies of these certificates.
• 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)

FAQ’s

• 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.