Medical Device Registration in The Middle East

Medical Device Registration Overview

The Middle East Medical Device market is considered a manufacturer’s future high growth market. Saudi Arabia, UAE, Turkey, and Israel are considered large markets in terms of size as well as in terms of payable capacity in the Middle East market.  From a Regulatory standpoint, most of the countries have their own systems in place, but at various stages of evolution. With a regional disparity in terms of accepting devices, the Middle East market seems a little complicated for importers and exporters to navigate through, for the purpose of medical device registration, but with the right guidance, this hurdle can easily be overcome. 

Freyr, with an extended presence in the Middle East region in Dubai, UAE, covers the entire spectrum of Regulatory support for Medical Devices required to obtain market authorizations and approvals in this emerging market. Foreign manufacturers must also appoint a medical device authorized representative in the Middle East, to help them with the registration process. The medical device Authorized Representative also supports in submitting all application documents for medical device registration.


Freyr Expertise

  • Product Classification and Registration services 
  • QMS Compliance strategy 
  • Local representation services
  • Gap Analysis of technical documents & quality systems
  • Regulatory support for product development documents such as, design history files
  • Regulatory support for Technical File Compilation 
  • Regulatory and Market Intelligence support
  • Document and Labeling Translation support
  • Health Agency liaising and support
Freyr Advantages


Freyr Advantages


Successful submissions for varied class of devices ranging from software to sutures


Local affiliate access to meet the challenges of authority and language-specific requirements


Dedicated personnel to provide Medical Devices and IVDs


In-country or legal representative support with a cost-effective model


Exclusive Delivery Center in Dubai, UAE