UAE Medical Device Registration Requirements

R

RAspecialist

Hi
I am currently looking for more information regarding the registration of medical devices in UAE. I have obtained the registration requirements document in English but still have a few more questions which I hope someone can help with (the MoH are not responding to any questions).
  • Once the registration dossier is compiled, where do I submit it?
  • Are there any registration fees?
  • How long does the process take from submission to response/acceptance?
  • Do I need to submit through a UAE based distributor?
  • I understand there are two routes, depending on whether you have CE mark, FDA, Australian etc approval - we have CE and Australia so how does this change the process?
  • How do I find out if the seven member states have their own specific regs - I've looked but not found anything so far.
Has anyone else had better luck in getting a response from the Minstry of Health directly?

Thanks :)
 

sreenu927

Quite Involved in Discussions
Once the registration dossier is compiled, where do I submit it?
Submit to your Marketing Authorisation Holder or local authorised representative
Are there any registration fees?
No
How long does the process take from submission to response/acceptance?
Do I need to submit through a UAE based distributor?
Yes
I understand there are two routes, depending on whether you have CE mark, FDA, Australian etc approval - we have CE and Australia so how does this change the process?
Registration approval from reference agencies such as USFDA, EU, TGA, JPMDA, HC is used to abridge the evaluation process.
How do I find out if the seven member states have their own specific regs - I've looked but not found anything so far.
I don't think the 7 member states have specific regulations.

See my response in blue.

Regards,
Sreenu
 
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