Renewal of Marketing Authorization for a Medical Device

about-the-service

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

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 Pharmaceutical Product Certificate (for locally manufactured pharmaceutical products), valid for one year from the date of issuance.

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.

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 Drug Control Department 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
Post-marketing monitoring requirements
Providing 3 samples (as per equipment type), certificate of analysis (as per equipment type), external and internal covers and brochures
type), external and internal covers and brochures - Acknowledgment of the company that equipment conforms to the specifications as per the Medical Equipment Manual (EC-Declaration of Conformity)