Changing a Medical Device distributor in Egypt

[nfox1978 - 2013]

Hi

We currently have a distributor in Egypt who has our medical device product licenses registered in his name. I am trying to find out if we terminate our agreement with the current distributor are the licenses automatically canceled by the medical device authority in Egypt.

We have this situation covered by our distribution agreement but i want to be sure the Egyptian MoH will allow us to cancel the existing licenses.

I am trying to ensure that if we move distributor we can re register the products with the competent authority with a new distributor without any issues.

I am very grateful for any help

 

[521937]

I'd also like to know the answer.
Besides,
Can we appoint a consultant act as an applicant?
Can a foreign manufacturer apply for a registration directly?
Can a single device have more than one valid license held by different registration certificate holders at the same time?
Thank you very much.

 

[xgg810116]

I also want to know the details.

Thanks in advance!

 

[tibon74]

hi ! anybody can answer?

 

[Mohammad Rashid]

Have anyone know in details to change the distributer

 

[LOGI2004]

Hello there ,

Any legal manufacturer must have an official distributer in Egypt either by official distribution contract or registration authorization letter.

Regarding the product licence ; only one holder is allowed according to MOH regulations.

To transfer the license to new distributor, you must have a termination contract for old distributer as well distributer must make a concession to the new distributor other wise all the approval license should be re registered .

hope this helps !

 

[tibon74]

Hi all,

What are documents needed for class I, IIa, IIb and III products ?
How much time it takes to het the approval ?
Thank you!

 

[login123]

Hello!

Do you have any more resources or information about this process?

Thank you!