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).
Thanks
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.
Thanks