ANSWERED ON THIS PAGE:
- What are the responsibilities of the Saudi Arabia Authorized Representative?
- Can we select a distributor as our representative in the KSA?
- What is the process for selecting an authorized representative?
Medical device manufacturers without a legal entity in the Kingdom of Saudi Arabia (KSA) must appoint a Saudi Arabia Authorized Representative. Your KSA Authorized Representative serves as a liaison between you and the Saudi Food & Drug Authority (SFDA), the country’s medical device regulator, but has many other responsibilities as well.
Advantages of a third-party Saudi authorized representative
An experienced, third-party representative is in the best position to serve the best interests of your company in Saudi Arabia. Your AR must field questions from the SFDA and perform post-market obligations, if necessary. They should protect your intellectual property and allow you to control your distribution options.
It is possible to appoint a distributor as your AR. But this can create unforeseen complications, especially when dealing with inquiries from the SFDA and other complex regulatory matters.
Emergo is an independent in-country representative with offices worldwide
We focus 100% on medical device and IVD regulatory issues, and your successful KSA registration is our goal. As your KSA Authorized Representative, we will act as your regulatory liaison with the SFDA and fully manage your registration effort. Here is how we can help:
- Submit your medical device or IVD registration to the SFDA
- Administer all registration fees
- Notify the SFDA of any changes to your device
- Coordinate adverse event reporting to the SFDA with you and your distributors
- Support device recalls or Field Safety Corrective Actions (FSCA) if needed
- Liaise between you and the SFDA
We are a fully independent Authorized Representative with experience handling medical device regualtory processes in Saudi Arabia.
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.