Exporting Medical Devices to Saudi Arabia

M

Mor628

Hi all,

Does anyone have experience dealing with export of medical devices to Saudi Arabia?

Our customer from KSA has claimed that, when exporting into KSA, the goods must only come from the country of the legal manufacturer as listed on our ISO 13485 certificate.

Since we are OBL/PLM, our goods come from eg: China, is stored in the Belgium warehouse, before it is shipped to customer in KSA. With our cert saying the legal manufacturer address is UK.

Does that mean we cannot do business with KSA? Our customer claims that if we do not wholly own the China sites and warehouses, our goods will not be allowed in KSA.
 
M

myusoffice

First Time Right...
Hi,

Please check SFDA website for more details:

You may need to get Marketing authorization first then hire a local Authorized representative if manufacturer already doesn't have one, classify your medical device, these all have associated fees and the process can be lengthier.

Hope this is helpful

Regards
Ziaur
 
M

Mor628

Dear Ziaur,

Thanks for your reply. Yes, I have checked their website and also sent an email but nothing has come out of it yet......

We do have Authorized Rep/Distributor in KSA and we are trying to get him to contact SFDA for a clearer answer. Hope that will work

Happy New Year to you :)
 
M

mdalkhen

Dear Mor,
Hope you are doing great, actually I am also staring OBL company to export my products to the middle east, is it possible we can communicate I would like to ask you some information about some papers and documents regarding that.
Regards. .
 
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