Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear RAPS-Community, 

we plan to sell medical devices in KSA in the future. We learned, that we need a local distributer who has to enroll in the case of low risk Medical Devices at the MDNR.

Does anyone have  a local distributer they can recommend? 

Thank you in advance for your help! 

Hi Anon

You may find that different distributors specialize in different types of devices. It could be valuable to attend an expo and meet some representatives in person.

https://www.arabhealthonline.com/en/exhibit.html

https://www.globalhealthsaudi.com/en/home.html


------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 07-Jun-2022 03:25
From: Anonymous Member
Subject: Distributer for Medical Devices in the of Kingdom of Saudi-Arabia

This message was posted by a user wishing to remain anonymous

Dear RAPS-Community,

we plan to sell medical devices in KSA in the future. We learned, that we need a local distributer who has to enroll in the case of low risk Medical Devices at the MDNR.

Does anyone have  a local distributer they can recommend?

Thank you in advance for your help! 

This message was posted by a user wishing to remain anonymous

Dear Ms LeBlanc, 

thank you very much for your answer, we will consider that. 

As we are searching a distributer atm, we read the processes for the registration of MD in KSA.
Could you or someone help with with a quite in-depth question:

Did we understand correctly, that it is neither in the case of Medical Device Listing (class A, non-sterile, non-measuring) nor in the case of higher class MD necessary to provide TD documentation? (we are collecting facts to sum up the effort for the sale of MD in KSA)

Thank you in advance!
Original Message:
Sent: 11-Jun-2022 10:14
From: Anne LeBlanc
Subject: Distributer for Medical Devices in the of Kingdom of Saudi-Arabia

Hi Anon

You may find that different distributors specialize in different types of devices. It could be valuable to attend an expo and meet some representatives in person.

https://www.arabhealthonline.com/en/exhibit.html

https://www.globalhealthsaudi.com/en/home.html


------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 07-Jun-2022 03:25
From: Anonymous Member
Subject: Distributer for Medical Devices in the of Kingdom of Saudi-Arabia

This message was posted by a user wishing to remain anonymous

Dear RAPS-Community,

we plan to sell medical devices in KSA in the future. We learned, that we need a local distributer who has to enroll in the case of low risk Medical Devices at the MDNR.

Does anyone have  a local distributer they can recommend?

Thank you in advance for your help! 

Hi Anon,
From my experience so far there is no difference in the TD of different MDs risk classes in Saudi. Same registration effort for a class A than a class D plus the coming UDI requirements.
Best regards,

------------------------------
Emilia Spallanzani
QA&RA Manager
Germany
------------------------------

Original Message:
Sent: 29-Jun-2022 02:03
From: Anonymous Member
Subject: Distributer for Medical Devices in the of Kingdom of Saudi-Arabia

This message was posted by a user wishing to remain anonymous

Dear Ms LeBlanc,

thank you very much for your answer, we will consider that.

As we are searching a distributer atm, we read the processes for the registration of MD in KSA.
Could you or someone help with with a quite in-depth question:

Did we understand correctly, that it is neither in the case of Medical Device Listing (class A, non-sterile, non-measuring) nor in the case of higher class MD necessary to provide TD documentation? (we are collecting facts to sum up the effort for the sale of MD in KSA)

Thank you in advance!
Original Message:
Sent: 11-Jun-2022 10:14
From: Anne LeBlanc
Subject: Distributer for Medical Devices in the of Kingdom of Saudi-Arabia

Hi Anon

You may find that different distributors specialize in different types of devices. It could be valuable to attend an expo and meet some representatives in person.

https://www.arabhealthonline.com/en/exhibit.html

https://www.globalhealthsaudi.com/en/home.html


------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 07-Jun-2022 03:25
From: Anonymous Member
Subject: Distributer for Medical Devices in the of Kingdom of Saudi-Arabia

This message was posted by a user wishing to remain anonymous

Dear RAPS-Community,

we plan to sell medical devices in KSA in the future. We learned, that we need a local distributer who has to enroll in the case of low risk Medical Devices at the MDNR.

Does anyone have  a local distributer they can recommend?

Thank you in advance for your help!