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?
