Renewal of Marketing Authorization for a Medical Device

Service Description

This service allows the renewal of registration of medical equipment with the purpose of importing and trading them in the UAE.

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.
• Complete stability and bioequivalence (if required), as well as pharmacovigilance and pharmaceutical analysis through the laboratory Issue the marketing authorization certificate for a medical device, valid for five years from the date of the committee’s approval.
• Issue the marketing authorization certificate for a medical device, valid for five years from the date of the committee’s approval

Conditions & Requirements

• Marketing Authorization Holder companies must be registered by Emirates Drug Establishment before they could register their products.
• The applicant must be a medical warehouse licensed by the Emirates Drug Establishment and have a valid license.

Required Documents

• The application form of renewing the registration of medical equipment and reagents
• The original registration certificate of the product issued previously by EDE
• A valid manufacturing certificate of the factory issued by EDE
• Certificate of free sale/ registration issued by the competent authorities in the country of origin
• A copy of all minor changes certificates issued by the Emirates Drug Establishment (if available) and certificates of quality conformity/ marketing authorization, such as EC, 510 (K), PMA as per the classification of the equipment, i.e. Class I, II, III, IV
• Acknowledgment of the company that equipment conforms to the specifications as per the Medical Equipment Manual (EC-Declaration of Conformity)