Ministry of Health

Ministry of Health and Prevention (MoHAP)

Regulatory Authority

Medical Device Regulation

UAE Medical Devices Registration Guideline

Official Language

Classification

Class I, IIa, IIb and III

Medical Device Registration in United Arab Emirates

• Register in the e-services, create a username and password (if not already registered) and access the electronic system.
• Submit the request through the electronic service and complete the payment to meet all conditions and required fees.
• The competent technical committees will deliberate the registration of products and then recommendations are to be submitted to the competent ministerial committee.
• Letters are to be addressed to the concerned companies stating the committee’s decisions.
• The company should complete the requirements and submit them via electronic service.
• 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.
• Issuing certificates of registration of products that have been approved.

Documents Required

• Application Form
• CE Mark certificate
• QMS certificate
• Technical documents
• Manufacturing site registration
• Letter of Authorization

Applicable QMS

ISO 13485

Registration Timeline

45 working days

Authorized Representative

Yes

License Validity

5 years