Global Star Rating System for Services
Menu
Search

Registration of a Medical Equipment

Start Service
Bookmark service

Service completion duration

  • 45 working days

View more

Service fees

  • Application: 100 AED
  • Registration of a medical device: 5,000 AED
View more
Export as
Export as  PDF
Export as  XLS

Service Rating

Average Rating : From 0 users

About the Service

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

Service Process

  • 1
    Login to the MoHAP website or smart app using the UAE PASS

    • 2
      Submit the request through the electronic service and complete the payment to meet all conditions

      • 3
        The competent technical committees will deliberate the registration of products and recommendations shall be submitted to the competent ministerial committee

        • 4
          Letters shall be addressed to the concerned companies stating the committee's decisions

          • 5
            The customer shall follow up with the Analysis Section of at the Drug Department

            • 6
              The company should complete the requirements and submit them via electronic service

              • 7
                The relevant technical and ministerial committees will re-deliberate the registration of products that have been deferred in advance as soon as companies complete the requirements

                • 8
                  The certificates of registration of products that have been approved for registration will be issued, provided all conditions and requirements are fulfilled. Registration certificates are valid for five years effective the date of committee's approval

                  • 9
                    The pharmaceutical certificates (for locally manufactured pharmaceutical products) will be issued and be valid for one year effective the date of issuance

                    Conditions & Requirements

                    1. Marketing Authorization Holder companies must be registered by MOHAP before they could register their products.

                    2. The marketing office or medical warehouse must be licensed by the Ministry of Health and have a valid license.

                    FAQ’s

                    1. What are the fees for the registration of a medical device?

                      • Application: AED100.

                      • Registration of a medical device: AED5,000.

                    2. What is the average length of time for the registration of a medical device?
                      45 working days.
                    3. What channels are available to apply for the registration of a medical device?
                      MOHAP Website and Smart Application.
                    4. What are the conditions and requirements for obtaining a medical device?

                      • Marketing Authorization Holder companies and product manufacturing sites must be registered in MOHAP prior to the registration of their products.

                      • The applicant must be a medical warehouse or marketing office licensed by the Ministry of Health and Prevention and must hold a valid license.

                    Service completion duration

                    45 working days

                    Service fees

                    Application: 100 AED

                    Registration of a medical device: 5,000 AED

                    Service channels
                    • MOHAP Website

                    • MOHAP Mobile App

                    Payment channels
                    • E- Payment

                    Target audience
                    • Medical warehouses

                    • Local pharmaceutical manufacturers

                    • Marketing offices

                    Department name

                    Drug

                    Sector name

                    Health Regulation

                    Main service

                    Medical, Pharmaceutical and Drug Licencing and Registration

                    Service Code

                    110-04-013-000

                    Service Classfication

                    Transactional

                    Service Type

                    Government to Business

                    Sub Service Type

                    Variation

                    Related Services
                    • This service is not linked with other services

                    Service Bundle

                    This service is not linked with any service packages

                    Number of Users

                    83

                    Number of Transactions

                    468

                    Notes

                    Marketing Authorization Holder companies must be registered by MOHAP before they could register their products.

                    This service accepts documents authenticated with the UAE PASS Digital Seal.

                    Required Documents
                    • Filling out the application form of registration completely and to be 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 Embassy of the United Arab Emirates.

                    • A copy of the product agency contract signed between the company and the agent.

                    • Certificate of quality conformity/ marketing authorization, such as EC (European Conformity), 510 K (Premarket Notification), PMA (Parts Manufacturer Approval) 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.

                    • Providing one samples, certificate of analysis (as per equipment type), external and internal covers and brochures.

                    • Acknowledgement of the company that equipment conforms to the specifications as per the Medical Equipment Manual (EC(European Conformity)-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.

                    Sustainable Goals
                    Good Health And Well-Being

                    Did you find the content useful ?

                    Give us your feedback so we can improve your experience


                    Yes No

                    Help us improve MOHAP website

                    Give us your feedback so we can improve your experience

                    Thank you for your feedback.