Authorized representative guide

In this guide

References reviewed: October 2026

The short answer: to represent a manufacturer from outside the Kingdom before the Saudi Food and Drug Authority (SFDA), your establishment needs:

• a separate authorized representative licence for each manufacturer it represents;
• an attested representation agreement subject to the Kingdom's laws, with its minimum contents;
• a person to deal with SFDA;
• procedures for vigilance and incident reporting within their deadlines, for post-market surveillance, and for UDI data.

The official references for this guide are at the end of the page.

Who this guide is for

• Establishments in the Kingdom that represent one or more foreign manufacturers and act for them before SFDA.
• If your establishment also imports and distributes, that activity has its own licence and requirements in the importer and distributor guide. The licensing requirements set each activity's requirements in its own section.

What SFDA requires of your establishment

SFDA requires the following, grouped by topic:

Licence and legal entity

• A legal entity under the laws of the Kingdom, or being part of one, with proof submitted.
• An establishment account in Ghad with an establishment number, and the authorized representative activity added to the fields and activities of the commercial account.
• A separate SFDA licence for each manufacturer you represent in the Kingdom.
• Where the main manufacturer has branch factories: it owns them fully.
• The licence runs from one to ten years as you choose, at 2,600 SAR per year. The authorized representative is not given an A, B, C or D category.
• Applying to renew the licence; you may apply up to 60 days before the current licence expires.
• Appointing a person to deal with SFDA, holding a suitable qualification in a relevant field.
• Appointing a person to deal with SFDA on vigilance and device incident reporting.
• Notifying SFDA of any change to the information submitted for the licence within 10 days of the change.
• Confirming every year that the information already submitted is still accurate and correct.

Quality management system

• General clause (7) names the authorized representative among those who give documented evidence of applying a quality management system under SFDA.MD/GSO ISO 13485:2017, or obtain an SFDA inspection report.
• The licensing procedures guide lists three alternatives for the quality document: the establishment's ISO 13485 certificate, the inspection visit report, or proof of applying the system by filling in the quality manual checklist published on SFDA's website.
• QMS inspection requirements apply to authorized representatives, and SFDA issues the inspection report within 10 working days of the end of the visit.

The representation agreement

• An agreement with the manufacturer that is attested and authenticated, and subject to the laws of the Kingdom.
• At minimum the agreement sets out: the activities the representative performs before SFDA, the device type or group, the representative's commitment to all post-market surveillance requirements SFDA publishes, and the agreement's term and how it ends.
• The same manufacturer does not appoint another authorized representative for the same device type or generic group in the Kingdom.
• On termination: the party that wants to end it notifies the other in writing. When the agreement ends or is not renewed, the manufacturer appoints a new representative, transfers all previous obligations to it at once, and notifies SFDA.
• The representative's responsibility for the covered devices does not end when it asks to terminate or when the agreement ends, until the manufacturer appoints a replacement or the covered devices are no longer on the market or with users.

Before SFDA and the market

• Representing the manufacturer in its dealings with SFDA, and providing any information or document SFDA asks for.
• Documenting how you carry out the operations your tasks need, with the related documents attached.
• Marketing Authorization application: the foreign manufacturer may choose its authorized representative to apply, once the representative holds its licence. The application and its attachments are submitted in the Marketing Authorization services in Ghad.
• Submitting and maintaining the appropriate UDI data in the Saudi-DI database, validating it at submission and every year, with the data available when the item is placed on the market.
• Cooperating with regulated establishments on the devices circulating in the Kingdom under the manufacturer's agreement.
• During the representation, making sure the manufacturer provides after-sales services, including servicing devices over their lifetime and supplying approved spare parts.
• Informing the National Center for Medical Devices Reporting (NCMDR) of delays or unavailability linked to a potentially high risk to the delivery of medical services.
• Advertising: the manufacturer or the authorized representative submits the advertising material with the Marketing Authorization technical files, and that approval is valid for as long as the Marketing Authorization certificate; or applies separately through the e-services portal.

Vigilance and post-market surveillance

• Reporting incidents and complaints to the NCMDR: within 2 days for a serious public health threat, 10 days for an incident that led or could have led to death or serious injury, and 30 days otherwise, counted from the incident or from becoming aware of it.
• Answering the NCMDR's follow-up question on an investigation within 5 days.
• A follow-up report with the investigation's progress and the reason for delay when the investigation passes 30 days. The final report comes within 15 days if the device needs no examination or technical assessment, 30 days if it must be withdrawn and examined in the Kingdom, and 60 days if outside it.
• A field safety corrective action in three stages: (1) reporting to the NCMDR within 2 days of the action letter; (2) notifying importers, distributors and healthcare providers within 5 days of that report; (3) submitting the implementation plan within 5 days of that report.
• Reporting any incident outside the Kingdom that affects devices circulating in it, explaining its circumstances and the manufacturer's corrective action taken or planned.
• Identifying the risks of safety alerts that affect the Kingdom, and providing supply and distribution information.
• Cooperating in SFDA's post-market surveillance studies and actions.

Records and inspection

• A database archiving all related data, documents and operations, easy to access and retrieve, for at least 5 years.
• Giving SFDA documents and information within 10 days of its request, and letting inspectors review documents during visits.
• Answering inspection findings on the form sent with the report, with a corrective action plan within the period SFDA sets, then carrying it out and notifying SFDA when it is done.

Does an authorized representative need a warehouse licence? Not as a representative. If it stores devices, it needs a warehouse licence or a third-party storage licence; if it rents space in a warehouse, it needs a third-party storage licence, and the transport and storage requirements then apply to it.

The documents your establishment needs

You receive your documents as Word files in your establishment's name, and you review and approve them your own way before you submit them — and we guide you step by step to issuing your approved edition.

The authorized representative package holds 112 files:

• 10 core documents;
• 28 procedures;
• 74 forms and records.

The counts follow the establishment's activity and its answers.

Core documents (10)

The eight shared documents (start here, the declaration, the quality manual, the quality policy and objectives, the management representative decision, the organization chart and job descriptions, the forms booklet, and the document list with retention periods), plus two authorized representative documents: its activity requirements and their records.

Procedures (28)

The fifteen shared quality system procedures (from document control P-01 to customer order review P-15), plus 13 authorized representative procedures:

Forms and records (74)

The shared quality system forms, plus 15 authorized representative forms:

• F-100 Register of representation licences and represented manufacturers
• F-101 Authorized representative licence file and documents
• F-102 Register of representation agreements and their scope
• F-103 List of device types and generic groups, and exclusivity check
• F-104 Documented evidence package, its index and the task file
• F-105 Correspondence log with the foreign manufacturer
• F-106 Manufacturer communication channel card
• F-107 Register of SFDA requests and enquiries
• F-108 Vigilance and NCMDR reporting register
• F-109 Register of overseas incidents and safety alerts
• F-110 Post-market surveillance plan and reports
• F-111 UDI and Saudi-DI data list
• F-112 Yearly confirmation entry and after-sales services
• F-113 Representation transfer and continuing responsibility file
• F-114 Authorized representative inspection file and findings

What we add from practice, which is not SFDA text: some of the package is a practical arrangement we suggest; leaving it out is not a breach of a published duty. It includes:

• a combined register of manufacturers and device types that you cross-check yearly for exclusivity;
• a communication channel with the manufacturer on a timing and language you agree;
• half-yearly post-market surveillance reports;
• tracking the dates of the manufacturer's UDI data updates.

Preparation steps

A suggested order, each step building on the one before:

1. Set up the legal entity, open the Ghad account, and add the authorized representative activity to the commercial account.
2. Sign the representation agreement with each manufacturer, have it attested, and check its four elements and the exclusivity of its scope.

3. Collect what you need from the manufacturer:

   • the ownership letter for any branch factories;
   • its device information and their UDI data.

4. Appoint the person who deals with SFDA, and the person responsible for vigilance and reporting.
5. Prepare the quality management system evidence, especially the reporting procedures and their deadlines and post-market surveillance.
6. Apply for a licence for each manufacturer you represent, and pay the fee for the term you choose.

7. After licensing:

   • file Marketing Authorization applications if the manufacturer chose you for that;
   • submit the Saudi-DI data before items are placed on the market.

8. Every year:

   • confirm the accuracy of the information submitted;
   • validate the UDI data.

   With every change: notify SFDA within 10 days.

Questions for your activity

Do I need a licence for each manufacturer I represent?
Yes, a separate SFDA licence for each manufacturer in the Kingdom.

How long is the authorized representative licence, and what does it cost?
From one to ten years as you choose, at 2,600 SAR per year.

What must the representation agreement contain?
At least four elements:

• the activities you perform before SFDA;
• the device type or group;
• your commitment to the post-market surveillance requirements;
• the term and how it ends.

It is attested, authenticated and subject to the Kingdom's laws.

Does my responsibility end when the agreement ends?
No. It continues until the manufacturer appoints a replacement, or until the covered devices are no longer on the market or with users.

What are the incident-reporting deadlines?

• 2 days for a serious public health threat;
• 10 days for an incident that led or could have led to death or serious injury;
• 30 days otherwise.

All are counted from the incident or from becoming aware of it.

Can a manufacturer have more than one authorized representative in the Kingdom?
Not for the same device type or generic group. The manufacturer does not appoint another representative for the same scope.

Questions we ask to tailor your documents to your activity

References