Any medical device manufacturer without a legal entity in Saudi Arabia must appoint an SFDA-licensed Authorized Representative (AR) before its devices can be registered or marketed in the Kingdom. The AR is not an optional service provider — it is a mandatory legal role defined by the Saudi Food and Drug Authority, and choosing the right one shapes your entire market entry into Saudi Arabia and the wider GCC.
What is an SFDA Authorized Representative?
A Saudi authorized representative is a company established in Saudi Arabia that holds an annually renewable AR license issued by the SFDA. In other words, it is the SFDA-approved Saudi authorized representative for a medical device manufacturer: the legal bridge between the foreign manufacturer and the SFDA: every registration, communication, and post-market obligation in the Kingdom runs through the AR.
The requirement applies to all device classes — A, B, C, and D — including in-vitro diagnostic (IVD) devices. Without a licensed AR in place, a foreign manufacturer cannot submit a Medical Device Marketing Authorization (MDMA) application at all.
What the AR does for you
Submits and manages your MDMA registration through the SFDA's GHAD portal, including the Technical File Assessment required under the MDMA2 route.
Acts as the official communication channel with the SFDA — responding to deficiency letters, clarification requests, and inspection matters within regulatory timelines.
Carries your post-market obligations in the Kingdom: adverse event reporting, field safety corrective actions (FSCA), recalls, and maintaining registration validity and renewals.
Coordinates with your local importers and distributors, who separately require a Medical Device Establishment License (MDEL) to bring your devices into the market.
Choosing an AR: independence matters
Many manufacturers appoint their Saudi distributor as their AR. This is legal — but it hands your regulatory file, and effectively your market access, to a commercial partner. If the distribution relationship ends, untangling the AR designation can stall your sales in the Kingdom for months.
An independent AR keeps the regulatory role separate from the commercial one: you can add, change, or terminate distributors freely while your registrations remain stable and under your control. For most manufacturers entering Saudi Arabia, an independent, SFDA-licensed regulatory consultant is the safer structure.
MRG as your Authorized Representative
MRG was founded in Riyadh in 2012 as an Authorized Representative and regulatory consultancy for medical devices, and holds SFDA Consultation Office license CO-2023-FO-0022 alongside ISO 13485:2016 certification. We act as independent AR for global manufacturers — handling SFDA registration and approval, device classification, GHAD portal submissions, and full post-market compliance — with offices in Saudi Arabia, the UAE, and Egypt for manufacturers entering the wider MENA region.
If you are planning market entry into Saudi Arabia, talk to our regulatory consultants about acting as your SFDA authorized representative. Learn more about MRG's SFDA Authorized Representative services.
Frequently Asked Questions
What are the requirements to be an SFDA authorized representative?
A Saudi company with a Commercial Registration covering an acceptable activity, a valid ISO 13485 certificate, a passed SFDA inspection, a valid Medical Device Establishment License, and dedicated staff for safety and regulatory functions. The AR license is renewed annually.
Is there an official SFDA authorized representative list?
The SFDA maintains a register of licensed establishments. Every legitimate AR holds a verifiable SFDA license number — ask for it and verify it against the SFDA registry before appointing. MRG's license is CO-2023-FO-0022.
How much does an SFDA authorized representative cost?
The SFDA's fee for the AR license itself is approximately SAR 2,600 per year. Service fees on top of that depend on the device portfolio and the scope of registration and post-market support required.
Can I change my authorized representative?
Yes. AR designation can be transferred to a new representative, and existing MDMA registrations move with it — though an uncooperative outgoing AR can slow the process, which is why manufacturers increasingly choose an independent AR separate from their distributor.
