Saudi SFDA MDMA Authorized Representative Transfer Playbook

The Operational Problem No General Guide Covers

Most Saudi Arabia regulatory content explains how to register a device. This post addresses a narrower, more painful question: you already have MDMA-listed devices in Saudi Arabia, and you need to change your Authorized Representative (AR). Maybe your AR is unresponsive, overcharging, or you've found a better partner. Perhaps your AR relationship has broken down entirely — they refuse to issue a No Objection Certificate, block your MDMA transfers, or simply stop responding to your emails.

The good news: SFDA regulation explicitly supports your right to change ARs without losing your MDMA listings. The process is faster than many manufacturers expect. But there are specific steps, fees, and edge cases you need to understand — particularly the nightmare scenario where the outgoing AR actively obstructs the transfer.

This playbook covers every scenario. It is sourced from SFDA's MDS-REQ-002 (Requirements for Licensing Medical Device Establishments, Version V5), the SFDA Investor Guideline for Authorized Representative Licensing, and the official SFDA fee schedule documents current as of early 2026.

Background: How the AR System Works

What the AR Does

Under SFDA regulation, every foreign medical device manufacturer without a legal entity in Saudi Arabia must appoint an Authorized Representative resident in the Kingdom. The AR:

• Holds an AR License (ARL) issued by SFDA through the GHAD electronic system

• Submits MDMA applications on behalf of the manufacturer

• Serves as the regulatory liaison between the manufacturer and SFDA

• Maintains post-market surveillance records and reports adverse events

• Holds copies of technical files and labeling documentation

• Authorizes importation of devices into the Kingdom

Key Regulatory References

AR License Basics

• Fee: SAR 2,600 per year per manufacturer contract (approximately USD 693)

• Validity: Annual renewal; renewal application must be submitted 60 days before expiry

• QMS requirement: AR must document and apply a Quality Management System per SFDA.MD/GSO ISO 13485:2016

• Separate license per manufacturer: The AR must obtain a separate SFDA license for each foreign manufacturer it represents

• Payment: Via SADAD system (SFDA billing number 109)

The Standard AR Transfer Process (Cooperative Outgoing AR)

When both parties cooperate, the transfer process is straightforward. According to SFDA's MDS-REQ-002 V5 and industry practice, the transfer takes approximately one to two weeks for the AR license portion, followed by the MDMA license transfer.

Step-by-Step Process

Step 1: Select and Contract the New AR

• Identify a new AR who is SFDA-licensed and holds an active AR license

• Execute a formal AR agreement between the manufacturer and the new AR

• The agreement must be authenticated by the relevant authorities (as required by the SFDA Investor Guideline)

• Ensure the new AR has a GHAD system account

Step 2: New AR Submits License Application

• The new AR submits an AR license application through the GHAD system for your specific manufacturer

• Attach the authenticated agreement and supporting documentation:

  • Proof of manufacturer identity and legal status

  • Letter from manufacturer confirming appointment of new AR

  • If the manufacturer has subsidiary manufacturing sites, a letter confirming all subsites are wholly owned by the main manufacturer

  • Clear computer-made sketch of the AR establishment location with GPS coordinates

Step 3: Pay the AR License Fee

• SFDA issues a bill through the Operating Sector Billing System

• Pay SAR 2,600 via SADAD system

• License is issued upon successful payment and document review

Step 4: Transfer MDMA Listings

This is the critical regulatory step. Per MDS-REQ-002, when a manufacturer terminates an AR agreement:

"Manufacturer shall appoint a new Authorized Representative and transfer all previous obligations to him immediately upon termination or non-renewal of the previous authorized representative agreement, and shall notify the SFDA with that."

The new AR initiates the MDMA transfer through the GHAD system:

1. The new AR submits a transfer request for each MDMA listing

2. SFDA reviews the transfer request

3. Upon approval, MDMA certificates are re-issued under the new AR's name

4. No new MDMA registration fee is required for the transfer itself — the existing MDMA license carries over

5. Product listings remain valid under their original expiry dates

Important timing restriction: You cannot submit an AR transfer request while an MDMA application is actively under review with SFDA. Complete any pending MDMA applications first, or wait until they are resolved, before initiating the transfer. This is confirmed by multiple SFDA-licensed ARs and is a practical constraint in the GHAD system

Step 5: Notify the Outgoing AR

• The manufacturer provides written notice to the outgoing AR confirming termination

• This is a regulatory requirement under MDS-REQ-002: "the manufacturer shall provide written notice to the authorized representative in order to terminate the Agreement"

Step 6: Post-Transfer Obligations

• Update any import authorizations to reflect the new AR

• Ensure the new AR receives copies of all technical files, labeling, and post-market surveillance documentation

• Verify that all MDMA listings appear correctly under the new AR in GHAD

Timeline for Standard Transfer

Transfer Costs

Multi-AR Rules: Can One Product Have Multiple Authorized Representatives?

This is one of the most misunderstood aspects of the Saudi regulatory system. The rules are explicit in MDS-REQ-002:

One AR Per Device Group

"Ensure there is no other authorized representative has been appointed for the same type or general group of medical devices."

The regulation is clear: you cannot have more than one AR for the same device type or general group simultaneously. Each device grouping must have exactly one AR at any given time.

What This Means in Practice

Exclusive vs. Non-Exclusive Distribution

While you can only have one AR per device group from a regulatory standpoint, the distribution arrangement downstream of the AR is a commercial matter:

• Exclusive distribution: The AR or a designated distributor holds exclusive rights to sell your products in Saudi Arabia

• Non-exclusive distribution: The AR can authorize multiple distributors to sell your products

The regulatory constraint (one AR per device group) is separate from the commercial question of how many distributors sell the product. A single AR can issue Letters of Authorization to multiple distributors, enabling parallel distribution channels — but there is only ever one AR on record with SFDA for each device group.

The Nightmare Scenario: Outgoing AR Won't Cooperate

Here is the situation many manufacturers fear: your relationship with the current AR has deteriorated. The AR refuses to issue a No Objection Certificate (NOC), ignores transfer requests, or actively blocks the MDMA transfer in GHAD. What are your options?

Critical Fact: SFDA Does Not Require the Old AR's Permission

This is the single most important point in this playbook. Multiple SFDA guidance documents and industry practice confirm:

Changing the Authorized Representative in Saudi Arabia does not require approval from the previous AR.

The SFDA system allows the manufacturer to appoint a new AR and transfer MDMA listings independently. The manufacturer holds the ultimate authority over who represents them. The AR's role is delegated — it does not give the AR ownership of the MDMA listings.

Escalation Pathway

Level 1: Formal Written Notice

Send the outgoing AR a formal written notice (email + registered letter) of termination in accordance with your AR agreement terms. Reference MDS-REQ-002, which states that "one of [the parties] may terminate [the agreement]." Include:

• Effective date of termination

• Confirmation that a new AR has been or will be appointed

• Request for cooperation in the MDMA transfer

• Deadline for response (typically 10–15 business days)

Level 2: Direct SFDA Notification

If the outgoing AR does not respond or refuses to cooperate within the deadline:

1. The manufacturer (directly or through the new AR) submits a formal notification to SFDA via the GHAD system

2. Include the termination notice sent to the old AR

3. Attach the new AR agreement and license

4. Formally request that SFDA process the MDMA transfer under MDS-REQ-002

SFDA has the authority to process the transfer without the old AR's consent, because the regulation mandates that the manufacturer "shall appoint a new Authorized Representative and transfer all previous obligations to him immediately upon termination."

Level 3: SFDA Escalation and Complaint

If the old AR actively obstructs the process (e.g., raises unfounded objections in GHAD):

1. Submit a formal complaint to SFDA through the GHAD system or via direct correspondence to the Medical Devices Sector

2. Document all communication attempts with the old AR

3. Provide evidence that the termination was executed properly under the contract terms

4. Request that SFDA intervene to complete the transfer

SFDA can override an uncooperative AR because the regulatory framework prioritizes the manufacturer's right to choose their representative.

Level 4: Legal Options Under Saudi Commercial Law

In extreme cases where the outgoing AR claims contractual breaches or seeks to block the transfer through legal action:

• Review the AR agreement carefully: Most standard AR agreements include termination provisions. Ensure you have complied with any notice periods and payment obligations

• Engage Saudi legal counsel: A local commercial lawyer can navigate the Saudi court system if the AR files an injunction or raises commercial disputes

• Key Saudi commercial law principle: Under Saudi law, commercial agency and representation agreements are governed by the Commercial Agencies Law. However, AR agreements for medical devices fall under SFDA regulatory jurisdiction, and SFDA's authority to process transfers supersedes private commercial disputes

• Practical reality: Most AR obstruction cases are resolved at Level 2 or 3. Legal proceedings are rare and typically involve broader commercial disputes beyond the AR transfer itself

What the Old AR Cannot Do

2026 SFDA Fee Reference for AR-Related Transactions

All fees are payable via the SADAD payment system. MDMA review timelines range from 35–60 working days depending on product type, risk classification, and the number of products included in the application.

USD conversions use an approximate rate of 1 USD = 3.75 SAR.

Practical Checklist: AR Transfer Readiness

Before Initiating the Transfer

• Review your current AR agreement for termination clauses, notice periods, and penalty provisions

• Verify that all MDMA certificates are current and not approaching renewal deadlines (renewals must be submitted 90 days before expiry)

• Confirm there are no pending SFDA queries or corrective actions on your MDMA listings

• Identify and evaluate potential new ARs — prioritize SFDA-licensed ARs with experience in your device category

• Prepare authenticated AR agreement with the new AR

• Compile complete technical file documentation (the new AR will need copies)

During the Transfer

• Execute the new AR agreement and submit the AR license application through GHAD

• Pay the SAR 2,600 AR license fee via SADAD

• Submit formal written termination notice to the outgoing AR

• Initiate MDMA transfer requests through GHAD under the new AR

• Notify SFDA of the AR change (required under MDS-REQ-002)

• Confirm all MDMA listings have been transferred correctly in the GHAD system

After the Transfer

• Update import authorizations to reflect the new AR

• Verify that the old AR can no longer authorize imports of your devices

• Confirm new AR has received all required documentation (technical files, labeling, post-market surveillance records)

• Update any NUPCO procurement registrations that reference the old AR

• If the old AR held your MDEL (Medical Device Establishment License) linkage, confirm the new AR has updated this

Common Questions

Do I need to re-register my products with the new AR?

No. MDMA certificates transfer to the new AR. You do not need to submit new MDMA applications or pay new registration fees. The existing certificates maintain their validity and expiry dates.

Can I transfer some MDMA listings to one AR and others to a different AR?

Yes, as long as the listings fall under different device types or general groups. You cannot split listings within the same device group across multiple ARs.

What happens to devices in the Saudi supply chain during the transfer?

Devices already imported and in the distribution chain remain valid. The transfer affects future import authorizations — only the new AR can authorize new shipments after the transfer is complete.

My AR license expired. Can I still transfer?

If the old AR's license has expired, the situation becomes more urgent but not impossible. SFDA may require the manufacturer to demonstrate that steps were being taken to appoint a new AR. Engage a new AR immediately and submit the transfer request with an explanation of the circumstances.

Can the AR also be the distributor?

Yes. SFDA regulation permits the AR to also perform the duties of importer and/or distributor. Many Saudi ARs offer bundled regulatory and distribution services. However, be aware of the commercial implications — using your AR as your sole distributor creates a single point of dependency.

What if my AR goes out of business?

If the AR ceases operations, contact SFDA immediately through the GHAD system. SFDA can facilitate an expedited transfer to a new AR. Document your attempts to reach the former AR and provide evidence of the business closure. This situation is treated similarly to the non-cooperative AR scenario — SFDA's priority is ensuring continuity of supply and regulatory compliance.

Key Takeaways

1. You have the right to change ARs at any time. SFDA regulation (MDS-REQ-002) explicitly supports manufacturer-initiated AR transfers. The old AR's permission is not required.

2. MDMA listings transfer without re-registration. Your existing MDMA certificates carry over to the new AR. No new registration fees apply to the transfer itself.

3. The process takes 3–6 weeks in cooperative scenarios. The AR license portion is fast (1–2 weeks). MDMA transfers add another 1–2 weeks.

4. One AR per device group is the rule. You cannot have multiple ARs for the same device type simultaneously, but you can use different ARs for different device groups.

5. SFDA escalation works. If the outgoing AR refuses to cooperate, the manufacturer can escalate directly to SFDA, which has authority to process the transfer independently.

6. Cost is manageable. The total SFDA fee for the transfer is just the new AR license fee (SAR 2,600/year). The main costs are commercial — the new AR's onboarding fee and any legal costs for agreement authentication.