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.

Our Presence


Expertise

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

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