Registration of Class III Medical Devices in UAE

[Nanoula]

Hi!!!!!!!!!!

Does anyone could help me?
We have a client which is distributor of medical device class III in EU. The manufacturer is based in EU. The manufacturer has appointed the distributor to register/export/ the medical devicesin UAE, Saudi Arabia and Egypt
Can the EU distributor proceed to the registration of the medical devices in MENA region?
We have adressed the a.m. request to the Health Authorities but we didn't get an answer.
Thank you

 

[J0anne]

Re: Registration of Medical Devices in UAE

Which MENA regions specifically?

 

[Access2hc]

Re: Registration of Medical Devices in UAE

Just curious - what was the initial concern for not registering immediately, were there any?

Cheers,
Ee Bin

 

[Nanoula]

Re: Registration of Medical Devices in UAE

My client wants to register the medical device in UAE, Saudi Arabia and Egypt

 

[Nanoula]

Re: Registration of Medical Devices in UAE

The initial concerns is that the manufacturer does not want to proceed to export in Middle East and he has appointent an EU DISTRIBUROR to proceed to the registration procedure and exports.

 

[tibon74]

Re: Registration of Medical Devices in UAE

Hi !
does anybody has information about medical device approval process in Egypt ?

 

[fialor]

Re: Registration of Medical Devices in UAE

Hi !
does anybody has information about medical device approval process in Egypt ?

It might be best for you to post on a separate tread for Egypt.
However I can share the following:
DPPC division controls registration through committee for the study of manufactured and imported medical device and equipment.
Class I, Class IIa and Class IIb are registered at the DPPC.

Not a lot of information but at least its a start.

 

[tibon74]

Re: Registration of Medical Devices in UAE

Thank you! I suppose that class III are regulated by CAPA, right ?
it would be very help if I have a list of needed documents