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Renewal of Registration of Medical Equipment

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Service completion duration

  • 15 working days

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Service fees

  • Application: 100 AED
  • Renewal of the registration of a medical device: 2...
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About the Service

This service allows the renewal of 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 online 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 are to be addressed to the concerned companies stating the committee's decisions.

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

            • 6
              The company should complete the requirements and submit them online.

              • 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 the conditions and requirements are met. Registration certificates are valid for five years effective the date of last expiry date of the previous certificate.

                  • 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 applicant must be a medical warehouse licensed by the Ministry of Health and have a valid license

                    Service completion duration

                    15 working days

                    Service fees

                    Application: 100 AED

                    Renewal of the registration of a medical device: 2,500 AED

                    Service channels
                    • MOHAP Website: www.mohap.gov.ae

                    • MOHAP Smart App

                    Service locations

                    • MOHAP Website - www.mohap.gov.ae -
                    • MOHAP Smart App
                    Payment channels
                    • E- Payment

                    Target audience
                    • Medical warehouses

                    • Local pharmaceutical manufacturers

                    Department name

                    Drug

                    Sector name

                    Health Regulation

                    Main service

                    Medical, Pharmaceutical and Drug Licencing and Registration

                    Service Code

                    110-04-013-013

                    Service Classfication

                    Transactional

                    Service Type

                    Government to Business

                    Sub Service Type

                    Auxiliary

                    Number of Transactions

                    181

                    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
                    • The application form of renewing the registration of medical equipment and reagents

                    • The original registration certificate of the product issued previously by the Drug Control Department

                    • A valid manufacturing certificate of the factory issued by MOHAP

                    • 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

                    • Acknowledgment of the company that equipment conforms to the specifications as per the Medical Equipment Manual (EC-Declaration of Conformity)

                    Sustainable Goals
                    Good Health And Well-Being

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