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.

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.