Issuance of Marketing Authorization for a Medical Device
Service completion duration
45 Working Days
Service fees
Application: AED 100
Registration of a medical device: AED 5000Registration of a medical device: AED 5000
Service Description
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 & 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
FAQ’s
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.
Service completion duration
45 Working Days
Service fees
Application: AED 100
Registration of a medical device: AED 5000Registration of a medical device: AED 5000
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
قواعد التسعيرة (2).pdf 356KB
Issuance of Marketing Authorization for a Medical Device (1).pdf 2463KB
USER MANAGEMENT_LOGIN (1).pdf 2235KB
Related Services
This service is not linked to any other services