An Overview of Medical Device Regulations and Requirements in the United Arab Emirates

Regulatory Authority

Drug Control Department (DCD)

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, 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

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

• Registration application with the company’s stamp.
• A copy of the valid registration certificate of the factory.
• A valid certificate FOS/ 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 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.

Language Requirements

Documentation and labeling can be provided in English.

Registration Timeline 

45 working days

Registration Fee

• Application: AED 100
• Registration of a medical device: AED 5,000
• Classification of product: AED 500

License Validity

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 Us?

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

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