Issuance of Marketing Authorization for a Medical Device

about-the-service

This services allows the registration of medical equipment with the purpose of importing and trading them in 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 Quality Control Lab
• Issue the marketing authorization certificate for a medical device, valid for five years from the date of the committee’s approval

conditions-and-requirements

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

required-documents

• Application form of registration signed and stamped by company.
• A copy of valid registration certificate of the factory
• A valid certificate of free sale/registration issued by the competent authorities in the country of origin certified by the UAE Embassy
• A copy of the product agency contract signed between the company and the agent
• Certificate 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
• Product's information, including description, formulation, types, sizes, models, accessories, usages, side effects, contradictions, warnings, precautions, usage guidelines, photos of packaging covers, brochures and usage manuals
• Provide laboratory requirements and analysis, as well as pricing for certain medical equipment
• Provide one sample, certificate of analysis (as per equipment 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)
• Safety and efficacy data (for products classified as Class III, IV)
• Special requirements: Certificate of conformity to equipment manufactured from animal products

faqs

• What is the fee for the registration of a medical device?
• Application: AED 100
• Registration of a medical device: AED 5000
• What is the average length of time for the registration of a medical device?
• 45 Working Days
• What channels are available to apply for the registration of a medical device?
• EDE Website
• What are the conditions and requirements for obtaining a medical device?
• Marketing Authorization Holder companies and product manufacturing sites must be registered in EDE prior to the registration of their products.
• The applicant must be a medical warehouse or marketing office licensed by EDE and must hold a valid license.