Local Representative / Distributors - United Arab Emirates

H

henry_fong168

Hi All,

I noticed that foreign companies that would like to market medical devices in United Arab Emirates (UAE) would need to appoint a local representative / distributor in UAE to manage the product registration.

Just wondering if there are any regulatory requirements / restrictions on how many local representatives / distributors we can have?

I know that in Saudi Arabia, we can appoint different local representative for each product category. What about UAE?

Thanks in advanced!
 
supadrai

supadrai

Lawyer
Hello henry_fong168,

I don't have a clear answer to this either. In reviewing this 2010 post:

UAE IVD Registration (Professional Use Only, Non-A, Non-B of EU Regulation)

originally directed to by moderator Ajit Basrur in 2015, it can be implied that more than one AR is possible.

Further, the main independent AR services sites don't post a warning about the importance of appointing an independent AR, as they do in many other jurisdictions.

Still further, this 2015 article from a law firm located in the UAE doesn't mention an express limitation:

Part I: Importation of Medical Devices and Drugs into the UAE - Al Tamimi & Company

And a foreign-owned company can technically be set up to become it's own AR, another fact militates ever so slightly in favor of multiple ARs - actually a liberal AR policy.

All this leads me to believe that you should be able to appoint more than one. But there is nothing explicit I've been able to find - so I'm not betting the bank on it.

Typically, if we don't want to pay someone to give us a reliable answer (which is usually), I'll try to mitigate the risk through contract terms meaning: (i) clear rights of termination of the appointment at the AR at the convenience of the manufacturer, and (ii) terms requiring cooperation with registration by additional ARs. If nothing else, this may start the conversation with the potential AR, from which you can glean additional data about the status of the AR policy.

On a side note, the UAE is a conduit to Iran so we also include a statement that they are not acting as an agent of Iran and will not export our products to Iran, just as a CYA in this environment of hostility and sanctions.

Sorry I couldn't provide you the clarity we all would like.
 
Last edited:
A

Access2hc

sound advice, and keep monitoring for regulations that would change it to a single AR. multiple AR policy is difficult to govern in the long run.

Cheers,
Ee Bin
Access2hc
 
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