Regulatory services Middle East
Regulatory requirements differ between the Middle East countries. From markets where no registration is required to countries where your products require full registration.
Gateway MedTech can support with:
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Advise which markets to prioritize. It could be a good strategy to start and get established in a relatively small market, where product registration is easy or not required at all, pending the registration approval in a larger or more complex market
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Clarifying the correct classification for your medical device or IVD based on the local applicable regulatory system
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Act as your Authorized Representative. Obtain the AR license and communicate on your behalf with the local authorities
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Prepare and submit your application to have your medical device or IVD’s registered in the country of choice
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Assure AR license or market authorization renewals or transfers are being dealt with;
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Support in the importation authorization documentation
