United Arab Emirates (UAE) Medical Device Requirements?

W

Watchwait

#1
Can anyone point me to a source for identifying the (Quality System) requirements for exporting a medical device into the United Arab Emirates? I have looked long and hard but to no avail. Thanks!!
 
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Al Rosen

Staff member
Super Moderator
#3
T

treesei

#5
Sorry. Forgot to clarify that it is not the exact country the original poster looked for but one of those countries that are developing regulations.
 
W

Watchwait

#7
Thanks to all for this great feedback. I have been in touch with the U.A.E. commerce representative who has told me mostly what I needed to know. BTW, at this time the U.A.E. have no unique requirements for imported medical devices. Typically however, they would be looking for conformance with the QSR &/or 13485.
 
R

raspec

#8
Was FDA approval not a requirement for your device as it pertains to UAE? I saw in another thread that a device had to be cleared for distribution in the country of origin. Was that not discussed in your correspondences with the UAE commerce rep. Also, can you share your contact information to the UAE rep. Good luck with everything.
 

AnaMariaVR2

Trusted Information Resource
#9
Do you have a contact in a local company/subsidiary? Then, contact that person & ask him/her about the latest & greatest Med. Dev. requirements in the UAE. Not sure how busy is the Ministry of Health, but as Ajit suggested I do agree that I would try those 2 sources first: Ministry of Health and/or local contact/insider.

Good luck!
 
D

dodonnel

#10
Does anyone have any experience on MOH review times in UAE? I haven't been able to find it anywhere.
 
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