Service overview
What is an SFDA Authorized Representative
An Authorized Representative (AR) is the Saudi company licensed by the Saudi Food and Drug Authority to act on behalf of a foreign medical device manufacturer in all dealings with SFDA. The role goes beyond merely mailing applications — the AR carries full legal responsibility for device safety in the Saudi market, signs the Marketing Authorization (MDMA), receives SFDA's first call on any safety report, and manages recalls and vigilance reporting. The device registration certificate (MDMA) remains in the manufacturer's name — the AR does not own it.
The Substantive September 2022 Shift — Strategic Implications
Before September 27, 2022, appointing an Authorized Representative was required only for high-risk medical devices (Class C and D), while low-risk devices (Class A and B) were exempt. After this date, SFDA cancelled the exemption, and Authorized Representative became mandatory for all classes without exception. This shift created significant challenge for foreign manufacturers who were selling Class A and B devices without an AR, as they now had to obtain a representative before any new shipment. Delay in AR appointment means halted consignment clearance and lost sales.
Why a Foreign Manufacturer Needs an Authorized Representative
| Reason | Details |
|---|---|
| Strict Legal Requirement | SFDA does not accept MDMA applications directly from foreign manufacturers |
| Filing Registrations | The AR signs and submits MDMA applications on behalf of the manufacturer |
| Market Responsibility | Receives reports, manages product recalls, responds to adverse events |
| Consignment Clearance | Every shipment entering Kingdom requires documents from the AR |
| Daily SFDA Communication | AR represents the manufacturer in all official correspondence |
| Fee Administration | Pays SFDA fees from AR account (preserving manufacturer's financial privacy) |
Independent Representative vs Distributor — Strategic Decision
Manufacturers may appoint their Saudi distributor as Authorized Representative, but international experience has proven separation between AR and distributor is better for the manufacturer:
| Criterion | Distributor as AR (Conflated) | Independent Representative (Motaded) |
|---|---|---|
| IP Protection | Weak — distributor sees all information | Strong — AR bound to neutral confidentiality |
| Distributor Selection Independence | Limited — conflicts with distributor's interests | Full — choose anyone you want |
| Distributor Change | Difficult — requires AR change too | Easy — does not affect license |
| AR Change | Difficult — may lose MDMA records | Easy — Motaded transfers file seamlessly |
| Conflict of Interest | Likely when selling competing devices | Non-existent |
| Neutral Regulatory Advice | Limited by distributor's interests | Objective and professional |
Legal Responsibilities of the Authorized Representative
| Responsibility | What It Covers |
|---|---|
| Registration and Approvals | Preparing and submitting MDMA files for each device + registration certificates |
| Fee Administration | Paying all SFDA fees on behalf of manufacturer via SADAD biller 109 |
| Post-Market Compliance (PMS) | Adverse event reports, recall coordination, FSCA procedures |
| Regulatory Communication | First point of contact with SFDA, responding to inquiries |
| Registration Updates | Notifying SFDA of device modifications (design, address, brand) |
| Shipment Management | Providing clearance documents to Saudi ports |
| Regulatory Intelligence | Tracking SFDA regulatory updates and notifying manufacturer |
| Reminders and Renewals | Renewing licenses before expiration + managing deadlines |
Important Regulatory Features
| Feature | Details |
|---|---|
| MDMA Certificate in Manufacturer's Name | AR does not own the license — remains manufacturer's property |
| AR Change Is Possible | Registrations transfer without losing previous MDMAs |
| Single AR for Multiple Classes | One AR may represent you for all devices |
| Multiple ARs Possible | For large manufacturers: split devices between several ARs |
| License Duration | 1-10 years by manufacturer's choice |
| ARL Issuance Time | 1-2 weeks from complete file submission |
AR Appointment Stages
The procedure proceeds through four stages: First — signing the mandate agreement between the manufacturer and Motaded specifying scope (all devices or specific classes) and term. Second — preparing the license file for GHAD submission, including Motaded's Commercial Registration, manufacturer's mandate, parallel licenses. Third — filing in MDEL/GHAD and paying SAR 2,600 fee via SADAD biller 109. Fourth — receiving the AR License (ARL) authorizing Motaded to submit MDMA applications on the manufacturer's behalf. Total procedure duration: 1-2 weeks.
Complete Fees for Authorized Representative Service
| Item | Amount | Notes |
|---|---|---|
| AR License (ARL) Fee | SAR 2,600 / year | Sourced from SFDA guide |
| License Duration | 1 to 10 years | Manufacturer's choice |
| Annual Renewal | SAR 2,600 / year | Mandatory before expiration |
| Value Added Tax | 15% | Added above the fee |
| MDMA Registration Per Device | By device class | Separate service |
Why Motaded as Your Authorized Representative
We are a regulatory consultancy with objective interest in your success. We have no conflict with your distributors and no aspiration to replace them. We have daily operational experience with SFDA and GHAD system, handling MDMA for Classes A, B, C, and D. We preserve confidentiality of your technical file and do not share it with any party. We provide periodic PMS reports to the manufacturer in English and manage recalls professionally. For comprehensive overview of all SFDA services from Motaded, see the main platform page.
Packages and Pricing
| Package | Annual Price | Inclusions |
|---|---|---|
| AR Basic Annual | SAR 8,000 | AR license for one year + SAR 2,600 government fee + representation for up to 5 models + clearance follow-up + basic safety reports |
| AR Standard Annual | SAR 18,000 | Everything in Basic + representation for up to 20 models + quarterly PMS reports + product recall management + direct SFDA communication for adverse events |
| AR Premium Annual | SAR 35,000 | Everything in Standard + unlimited models + monthly PMS reports + adverse event handling within 24 hours + monthly regulatory advisory support |
| Additional Services | Case-by-case | MDMA registration per device (separate service), legal advisory, transferring registrations from another representative, specialized distribution and clearance contracts |
Multi-Year Subscription Discounts
| Subscription Term | Discount | Effective Annual Price for Standard Package |
|---|---|---|
| One year | No discount | SAR 18,000 / year |
| 3 years (annual renewal) | 10% | SAR 16,200 / year |
| 5 years prepaid | 15% | SAR 15,300 / year |
| 10 years (maximum) | 20% | SAR 14,400 / year |
Package Inclusivity — Covered and Excluded
| Item | Status |
|---|---|
| Annual ARL license fee SAR 2,600 | ✓ Covered |
| Mandate agreement preparation and filing | ✓ Covered |
| Daily SFDA communication | ✓ Covered |
| Port consignment clearance documents | ✓ Covered |
| MDMA registration per device | ✗ Separate service with government fee by class |
| SFDA device fees (SAR 15,000-23,000 per device) | ✗ Paid by manufacturer directly |
| 15% Value Added Tax | ✗ Added to price |
| Travel and on-site meetings with SFDA | ⚠️ Within reason — exceptions case-by-case |
Service snapshot
Foreign Medical Device Manufacturers
Service Channels
Duration and Continuity
Objectives
We enable Saudi market entry with full legal procedures without needing to establish a local company.
We preserve confidentiality of your technical file and do not share with your distributors or competitors.
We handle daily SFDA communication, translate regulations, alert you to regulatory changes.
Work Tracks
Mandate and Licensing
Medical Device Registration
Shipment and Clearance Management
Post-Market Compliance (PMS)
Steps to Obtain
Areas of Work
We represent you in all SFDA dealings, from application submission to adverse event management.
We follow product safety in market, prepare vigilance reports, coordinate FSCA recalls when needed.
Extra data
Class A & B Device Representation
We represent manufacturers for all device classes following the September 2022 AR mandate extension to Class A and B.
Class C & D Device Representation
We represent Class C and D devices which have always required AR with higher regulatory requirements.
IVD Device Representation
We master IVD device requirements across all classes, from general to Annex II List A.
Vigilance Reporting Management
We receive the first report from SFDA on any safety incident, investigate, prepare report for manufacturer, coordinate procedures.
Transferring Registrations from Another AR
We handle transferring your registrations from a previous representative to Motaded in 2-4 weeks without losing MDMAs.
ARL Renewal Before Expiration
We track ARL expiration and renew it automatically 60 days before expiration to avoid halting consignment clearance.
FAQs
- Does every foreign manufacturer need an AR?
Yes, since September 27, 2022 mandatory for all medical device classes without exception.
- Do I own the MDMA certificate?
Yes fully. AR submits on your behalf, but MDMA issues in manufacturer's name and ownership.
- Can I change AR later?
Yes, Motaded transfers your file without losing previous MDMAs. Procedure takes 2-4 weeks.
- How long does ARL acquisition take?
1-2 weeks from complete file submission in GHAD system.
- Difference between ARL and MDMA?
ARL is AR's annual license SAR 2,600. MDMA is device license SAR 15,000-23,000. ARL precedes MDMA.
