Is it possible to have more than one authorized representative in Saudi Arabia?

M

ManTheDan88

Ok so here's the deal.

  • Currently my company is in contract with one of our distributors in Saudi Arabia for them to be our authorized representative.
    • They have registered only a portion of our product line.

  • We just received a request by another distributor who wants to sell our product (most of which is not registered) and they would be willing to register for us as an authorized representative.

So my question is, is it possible to have more than one authorized representative in Saudi Arabia?

I've done some research but haven't found anything on the subject.

Thanks a bunch in advance.
 
M

ManTheDan88

I read over the SFDA regulations specifically MDS - G3 GUIDANCE FOR MEDICAL DEVICE AUTHORIZED REPRESENTATIVES which states the following:

Comments:
1. Every manufacturer established outside the KSA (i.e. an overseas manufacturer) is required to appoint an authorized representative, resident within the KSA, to act on its behalf. The SFDA will contact the overseas manufacturer through the authorized representative with regard to the manufacturer’s obligations under the Medical Devices Interim Regulation. Where a manufacturer intends to place medical devices onto the KSA market that fall within more than one device category or generic device group, it may either designate a single authorized representative for all the devices it intends to market, or designate a different authorized representative for each device category or generic device group.

The way I interpret this is that a manufacturer is allowed to only have more than one authorized representative if they have medical devices that fall into more than one device category (i.e. In vitro diagnostic and implantable). Since we are already in contract with an authorized representative for the medical device category for In-Vitro Diagnostic Devices, the guidance above along with the statement included in the agreement for authorized representative services (I the undersigned declare that I have not designated any authorized representative other than that who is party to this agreement to act on my behalf for the medical devices listed in Section F) I think is evidence enough that you cannot have more than one authorized representative for the same device class. As this is just a guidance and everything is up to interpretation, does anyone have any experience in this?
 

Marc

Fully vaccinated are you?
Leader
Sorry no one answered at the time. Thanks for coming back and letting us know what you found out. We appreciate it. Hopefully someone can add more per your request.
 

sreenu927

Quite Involved in Discussions
Hi,
Yes, you can have multiple authorized reps in Saudi. you should have agreement with each individual AR separately with the product categories listed in it.
During registration, you should provide a letter of authorisation to your AR for that particular product category.
Although its s guidance document, they are recommended to use.

Regards,
Sreenu
 
Z

zypher005

Hi,
Do you know is it possible to download the complete classification catalog for medical devices? Or it's necessary to register an account at SFDA web site, and only the company in Arabia can do the registration?
 
S

Sharif.Kullab

Legally , you can not have more than one Authorized Representative for the same category of devices in Saudi Arabia. But you can specify the categories for each authorized representative if you managed to get multiple repesentatives.
 
S

Sharif.Kullab

Hi,
Do you know is it possible to download the complete classification catalog for medical devices? Or it's necessary to register an account at SFDA web site, and only the company in Arabia can do the registration?
there is no such a catalouge or guidance so far, you have to register in their website and apply directly.
 
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