UAE Medical Device Registration

Medical Device Registration in United Arab Emirates & Regulations

» Regulatory Authority

The Ministry of Health’s (MoH) Registration and Drug Control Department (DCD) oversees the regulation of medical devices.

The UAE’s Ministry of Health and Family Affairs (MOHAP) is in charge of assuring the standards and security of medical services and products. It establishes regulations for professionals, facilities, and service providers, controls drugs and medical equipment, encourages public health programs, and carries out research on health-related topics. 

MOHAP also designs and builds hospitals and other healthcare facilities, as well as launches health promotion initiatives to inform the public about healthy habits and illness prevention. Its duties cover a wide range of industries, including public health, healthcare infrastructure, and health promotion.

» Link for Regulatory Authority 

https://www.dha.gov.ae/en/HealthRegulation/Pages/drugcontrolnew.aspx

» Local Regulation

UAE Medical Devices Registration Guideline

» Link for Regulation 

https://mohap.gov.ae/en/services/registration-of-a-medical-equipment

» Medical Device Classification

» Local Listing or Registration in UAE

1. Register^* in the e-services, create a username and password (if not already registered) and access the electronic system.
2. Submit the request through the electronic service and complete the payment to meet all conditions and required fees.
3. The competent technical committees will deliberate the registration of products and then recommendations are to be submitted to the competent ministerial committee.
4. Letters are to be addressed to the companies concerned stating the committee’s decisions.
5. The customer will follow up with the Analysis Section of 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. Issuing certificates of registration of products that have been approved for registration following fulfilling all conditions and requirements. Registration certificates are valid for five years effective the date of committee approval.
9. Issuing pharmaceutical certificates (for locally manufactured pharmaceutical products) valid for one year effective the date of issuance.

*Marketing Authorization Holder companies must be registered by MOHAP before they can register their products and the marketing office or medical warehouse must be licensed by the Ministry of Health and have a valid license.

» Documents Required for UAE Medical Device Registration

Application Form
Completed, signed, and stamped by the company.

Factory Registration Certificate
A valid certificate of the manufacturing facility.

Certificate of Free Sale (CFS)
Issued by competent authorities in the country of origin and certified by the UAE Embassy.

Agency Agreement
A copy of the product agency contract between the company and the local agent.

Quality Certificates
Depending on the device classification (Class I–IV), provide relevant certificates such as:

• EC Certificate (European Conformity)
• 510(k) Premarket Notification (for FDA)
• PMA (Premarket Approval)

  Product Information
  Detailed description including formulation, types, sizes, models, and accessories.

  Post-Marketing Monitoring Plan
  Outline of how the product will be monitored after market release.

  Product Labels and Brochures
  Clear images or samples of inner and outer packaging, labels, and user brochures.

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» Language Requirements

Documentation and labeling can be provided in English.

» Registration Timeline 

45 working days

» License Validity for UAE Medical Device Registration

5 years; Classification validity is 3 yrs (GG)

» Who should make this Communication?

• Manufacturer
• Authorized Representative

» When to make this Communication? 

Before placing a medical device into the UAE market.

» Why Choose OMC Medical?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk

Frequently Asked Questions

1. What is the process for UAE medical device registration?

Medical devices in the UAE must be registered with the Ministry of Health and Prevention (MOHAP). The process involves submitting a detailed application, classification, and compliance with UAE regulations.

2. Are all medical devices required to be registered in the UAE?

Yes, all medical devices intended for import, distribution, or sale in the UAE must be registered to ensure safety, quality, and efficacy.

3. How long does the UAE medical device registration process take?

The registration process typically takes 4-6 months, depending on the completeness of the application and the classification of the device.

4. Can foreign manufacturers register devices without a local presence?

No, foreign manufacturers must appoint a local authorized representative in the UAE to handle the registration process and regulatory compliance.

5. Do OMC medical have office in UAE

yes, we are having office in UAE, please check location.