Common questions regarding the appointment of a Saudi Arabia Authorized Representative for medical device companies
How can we transfer to a new authorized representative in the KSA?
It is possible to obtain a new authorized representative; however, it requires a new AR license. You must cancel the existing AR license before requesting a new one. You cannot submit an AR transfer request if your MDMA application is in process. Emergo can assist with AR transfer requests.
Can we select more than one AR?
If you are marketing several devices that fall into different categories (e.g., single-use devices versus electromechanical devices), you can have different ARs for each category, though it is not required. You may use one AR for all product categories. Manufacturers can also have more than one AR for the same product category by specifying the product range that will be represented by each AR within the individual AR mandates.
Do we need an AR license?
If it is your first time to market, you must obtain an AR License through the SFDA Medical Device Establishment Licensing System (MDEL).
Who "owns" the MDMA approval – the AR or the manufacturer?
The MDMA is issued in the manufacturer’s name; the manufacturer owns the registration.