Renewal of Marketing Authorization for a Medical Device
Service completion duration
15 working days
Service fees
Application: AED 100
Renewal of the registration of pharmaceutical product for general sale: AED 2500
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)
Service completion duration
15 working days
Service fees
Application: AED 100
Renewal of the registration of pharmaceutical product for general sale: AED 2500
Service channels
Website: www.ede.gov.ae
Support
Call Center: 80033784.
Email: info@ede.gov.ae.
Target audience
Medical Warehouses
Local Pharmaceutical Manufacturers
Marketing Offices
Payment channels
E-Payment
Resources
USER MANAGEMENT_LOGIN (11).pdf 2235KB
Issuance of Marketing Authorization for a Medical Device (2).pdf 2463KB
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Issuance of Marketing Authorization for a Medical Device