Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear all,

I received a purchase order for several kinds of medical devices from a clinic sited in Dubai. This clinic is the final destination of the products. The clinic will not commercialize the product in UAE, they would just use them internally.

In this case, is it still necessary

• to appoint a local authorized representative in UAE?
• to register every single medical device on MOHAP?

I think that these requirements are necessary in the case of distribution of medical devices in UAE and not in the case when the products go directly to the final user but I am not sure if it materially feasible.

Obviously, in the case it is necessary to appoint the local authorized representative and to register every medical device the business would not be economically viable.

Thank you for any kind of response

P.S. 

I cannot find anywhere the health legislation of UAE.

Hello Anon

The Ministry of Health and Prevention makes legislation available in English translation here:
https://mohap.gov.ae/en/about-us/legal-references

Federal law #8 of 2019 mentions exceptions for items brought into the country for personal use, and for donated items, but neither of those seems applicable to your situation.

Without a local representative, I am not sure how you might manage vigilance activities, if the ministry might take an interest in quality problems with the devices in whichever clinics you might have sent them to.



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Anne LeBlanc
United States
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Original Message:
Sent: 13-Jun-2022 05:40
From: Anonymous Member
Subject: Exporting medical devices to final user located in Dubai (UAE)

This message was posted by a user wishing to remain anonymous

Dear all,

I received a purchase order for several kinds of medical devices from a clinic sited in Dubai. This clinic is the final destination of the products. The clinic will not commercialize the product in UAE, they would just use them internally.

In this case, is it still necessary

• to appoint a local authorized representative in UAE?
• to register every single medical device on MOHAP?

I think that these requirements are necessary in the case of distribution of medical devices in UAE and not in the case when the products go directly to the final user but I am not sure if it materially feasible.

Obviously, in the case it is necessary to appoint the local authorized representative and to register every medical device the business would not be economically viable.

Thank you for any kind of response

P.S.

I cannot find anywhere the health legislation of UAE.