Going by the reports, the medical device market in Middle East is expected to reach US $ 31.6 billion by 2025. But the diversified culture in terms of ethnicity and language in addition to the developing Regulatory framework (in some countries), taping the Middle Eastern market potential, however, might be challenging for device manufacturers who are willing to register their products in the region. To get a competitive hold on region’s market potential, they are required to understand the Middle Eastern Regulatory regime. To simplify and streamline the market entry procedures, one should start with uncovering:

  • Health practices and corresponding Regulatory Authorities (each Middle East country nation follows their own i.e. SFDA – Saudi Food & Drug Authority, NHRA – National Health Regulatory Authority, MOH - Ministry of Health, etc.)
  • Exclusive additional Manufacturing Practices apart from the general GMP, given the religious exceptions
  • Device classifications and product groupings
  • Tenure of licence and renewal procedures in each of the ME nations
  • The legislative documents required and the linguistic barriers
  • Local agencies for import and distribution of devices
  • Additional authorizations required apart from local authorizations

Apart from the above mentioned, the Middle East medical device market entry requires attention to many more aspects that would ease procedural complexities. To give you a complete perspective on the region’s Regulatory landscape and best practices on medical devices registrations and licensing, Freyr is organising an exclusive webinar “Medical Device Registrations – A Global Perspective” – Part 2 Middle East on September 27th, 2017, 9:30 AM EST, 5:30 PM GST, 2:30 PM UK; Duration:45 min. Get hold of Mid-Eastern medical device market right away. Register your spot.


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