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

[davidespada - 2011]

Hi all,
we are in the process of register our IVDs at UAE MHO.
It is not clear the classification: do you know if IVD (professional use only, non-A, non-B of EU regulation) are within Class I or are classified apart?

Thanks in advance,
regards,
DavideSpada

 

[Stijloor]

Can someone help Davide?

Thank you very much.

Stijloor.

 

[Marc]

Another 'Bump' in case one of the Medical Devide gurus here can help with this one. My Thanks in advance!

 

[davidespada - 2011]

Hi All,
I had a tips directly from UAE: IVDs are classified as Class I.
Fortunately I don't have any list A or B device in my product portfolio, by the way I guess that UAE MHO doesn't make difference if anyone is interested.

Regards,
Davide

 

[bio_subbu]

Hi all,
we are in the process of register our IVDs at UAE MHO.
It is not clear the classification: do you know if IVD (professional use only, non-A, non-B of EU regulation) are within Class I or are classified apart?

Thanks in advance,
regards,
DavideSpada

Hi DavideSpada

I don’t know exactly about your IVD product classification, the Medical Device Regulation in UAE is supervised and directed by Drug Control Dept / MOH. But the Classification, requirements and evaluation of Medical Devices in UAE will be mainly simulation of rules and regulations recognized by the international regulatory benchmarks, which are mainly: (Refer page 4, Article1 of attached UAE Medical Devices Registration Guidelines)

***DEAD LINKS REMOVED, BUT SOME OF THE FILES ARE ATTACHED.

Please refer following guidance documents with respect to Medical Devices registration in the UAE, since you are in the process of product registration, the guidance documents will be more useful to you.

Registration Procedure

Forms

Application Form for Registration of a Medical Device

Receipt for submission of registration dossier Medical Device Product

For more clarification please contact UAE MOH directly.

Regards
S. Subramaniam

 

[davidespada - 2011]

Thanks for the info Bio_Subbu.
I already went through all the guidance provided by UAE MHO and also I have provided the first form to my Local Distributor (who actually acts also as Authorized Representative).
The question arose while reading the Guidance: Annex III speak about classification of Medical Device but there is no mention at all about IVDs. So I can only guess that IVDs are "non-invasive device", thereby classified as Class I.
What blow my mind is that documents required from MHO differ from Class to Class and from risk order of the Device.
Unfortunately IVDs are not well regulated, so it is difficult to understand which documents are required.
By the way, we should have an answer to the question soon, as my Distributor have fixed an appointment with MHO.

Thanks!

 

[Mark Meer]

...Please refer following guidance documents with respect to Medical Devices registration in the UAE, since you are in the process of product registration, the guidance documents will be more useful to you.
Registration Procedure

Does anyone know if these attachments are still valid?
They don't appear to be dated, and I can't seem to find them on the MoH website.
These are great references (concise, clear), but given that the post was over 8 years ago, I'm not certain if they're still reflective of current UAE regulatory thinking.

SOME DEAD LINKS REMOVED...

 

[Marc]

Does anyone know if these attachments are still valid?

I have been reviewing hundreds of dead links. The original links appear to be dead 404 pages.

Please remember folks, links go dead -So, it it's a government document a link if appreciated and expected. But if you come across a government document (typically government documents are NOT copyrighted), downloading the document and attaching it to your post really, really helps.