Authorized Representative for Medical Devices in Saudi Arabia

The Saudi Food and Drug Authority (SFDA) requires medical device manufacturers to appoint an authorized representative (AR) in Saudi Arabia before marketing their products. The AR will be the local representative responsible for regulatory activities such as medical device registration and postmarketing surveillance.

Appointing an authorized representative requires submitting an AR application to SFDA to receive an AR license (ARL). It is a fast process, and the manufacturer can change the authorized representative whenever needed without losing the previously approved product licenses (MDMA).

Here are a few important notes:

• Appointing an AR is a 1-2 week process.
• Changing the AR is possible at any time.
• Manufacturers can appoint several ARs (with conditions).
• A valid AR license is necessary before device registration.
• Shipment clearance requires a valid AR license.

This post will discuss the AR role and how to appoint one for your company.

What is an authorized representative (AR)?

The authorized representative is the local Saudi company that legally represents the international medical device manufacturer in Saudi Arabia. SFDA requires companies to appoint an AR before registering their product; the AR is not necessarily the distributor.

Independent AR vs Distributor as AR

International medical device manufacturers have two options when they want to appoint an AR in Saudi Arabia:

1. Appoint their commercial distributor to also act as their AR.
2. Appoint an independent AR (non-commercial).

Most legal manufacturers prefer to appoint an independent AR in Saudi Arabia, a practice common in other regions such as the EU.

Independent AR advantages

When an international manufacturer contracts with an independent AR, such as PharmaKnowl, they receive a package of advantages that include:

• Flexible branding
  Register multiple brand names for the same product.
• Multiple distributors
  Work with different importers without restrictions.
• Stable costs
  Fixed annual fee with no sales-based charges or commission on shipments.
• Full control
  Keep ownership of your product licenses.
• Strong regulatory support
  Help with product registration and post-market compliance.
• Data confidentiality
  Protect sensitive business information.
• Unbiased advice
  Get objective insights focused on your success.
• Up-to-date regulatory info
  Stay informed and compliant at all times.
• Better communication with authorities
  Faster and smoother regulatory processes.
• Quality and safety support
  Ensure ongoing compliance and product standards

Responsibilities

The local representative company will cover the following set of responsibilities in Saudi Arabia on behalf of the international legal manufacturer:

• Act as the legal authorized representation at the SFDA
• Provide regulatory support, such as registrations, MDMA Updates, and renewals
• Submit the Unique Device Identification (SFDA UDI)
• Clarification of SFDA regulations for the manufacturer
• Provide Market Intel & insights
• Post-marketing Surveillance
  • Reporting adverse events and incidents
  • Submission of corrective actions
  • Conduct post-marketing clinical follow-up (PMCF) in Saudi Arabia
• Facilitate device maintenance
• Support shipment clearance issues
• Facilitate the visits of the maintenance team arriving from out of the country

AR Standard Qualities

• Excellent coverage of essential duties
  Regulatory compliance, safety monitoring, Communication skills, etc.
• Regulatory Intelligence:
  Promptly share regulatory updates with the ability to identify impact areas and risk levels.
• Influential access to SFDA
  For support and problem-solving.
• Regulatory systems management
  Tracks key milestones, including registrations, renewals, and expirations, via dedicated internal systems.
• Supply chain planning capabilities
  E.g., for arrival schedules vs approval dates and import permits
• Work within the manufacturer’s internal e-systems
  To update regulatory milestones, such as registration dates, expirations, and renewals.
• Inspections
  Support the preparations and good standing for the SFDA inspections
• Clearance
• Support shipment clearance at the port when needed by the manufacturer and its distributors
• Resolve other in-market issues.

AR for Low Risk Class Devices

In the past, SFDA required AR only for high-risk classes. However, since September 27, 2022, AR has become mandatory on low-risk devices as well, due to the cancellation of the low-risk registration procedure (MDNR).

AR License (ARL) Requirements

Here is the list of the SFDA requirements for a local company to act as an authorized representative:

• A Saudi company with a Commercial Record (CR) that reflects an acceptable economic activity as per the SFDA for medical devices.
• Availability of a Quality Management System (QMS)
• A valid ISO 13485 certificate.
• Pass the SFDA inspection.
• A valid SFDA medical device establishment license (MDEL)
• Dedicated Saudi professional for safety and regulatory functions.

AR Agreement

The SFDA mandates a specific AR agreement template that must be signed by the legal manufacturers and their Saudi-authorized representative. Here are a few essential related notes:

• The agreement must follow the format defined by SFDA. Download: Authorized Representative Agreement Template.
• Manufacturers can appoint several ARs (with conditions).
• AR Agreement must be apostilled or legalized.
• The minimum AR validity is one year.
• The AR Validity should align with the AR Agreement
• The AR agreement must be renewed upon expiry to maintain continuous regulatory coverage and market authorization. The renewal process can be initiated up to 60 days before expiry to ensure uninterrupted compliance.
• A valid AR agreement is required before initiating or maintaining MDMA registration.

Changing Your Authorized Representative

Changing the authorized representative in Saudi Arabia does not require the previous AR’s approval. The process takes about one week, followed by the transfer of the medical device licenses (MDMA). Therefore, there is no need to re-register the products after transferring the AR.

Fees

The SFDA license fee for an authorized representative certificate is SAR 2,600/year (USD 693.33). For more details about SFDA charges, refer to our article: SFDA Fees.

Authorized Representative Provider

PharmaKnowl is an SFDA-licensed authorized representative trusted by famous medical device and MedTech companies worldwide. If you need an AR for your first market entry or to transfer from a current AR in Saudi Arabia, please contact us for a proposal. You can also schedule a meeting with us to answer your questions.

Read More
SFDA Registration