The Saudi Food and Drug Authority (SFDA) requires medical device manufacturers to appoint an authorised representative (AR) in Saudi Arabia before marketing their products. The AR will be their legal representative responsible for pre/post-marketing regulatory compliance, such as medical device registration and reporting adverse events and incidences. The appointment is done by submitting a signed AR agreement to SFDA.

It is a fast process to appoint a new authorised representative or change a current one in SFDA. Here are a few initial notes:

• Appointing an AR is a 1-2 week process.
• Changing the AR is possible at any time without permission from the previous AR.
• Manufacturers can appoint several ARs (with conditions)
• A valid AR license is necessary before registration and marketing in Saudi Arabia.
• 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 authorised representative?

Authorised representative is the local Saudi company that legally represents the international medical device manufacturers in Saudi Arabia. SFDA requires companies to appoint an AR before they can register their product. AR is not necessarily the product distributor.

Authorised Representative Options

Any medical device distributor with a valid SFDA license can be an authorised representative. However, the optimal option is to appoint an independent (non-commercial) AR to maintain compliance and facilitate the business between the manufacturer and its distributor(s).

Here are the AR company requirements:

• Saudi medical device company
• Licensed by SFDA for medical device activities.
• Maintains a quality management system (QMS)
• Hold a valid ISO 13485 certificate.
• Have dedicated staff for safety and regulatory functions.

Independent AR v.s Distributor as AR

Most legal manufacturers opt to appoint an independent AR since it is the best practice that provides business stability in addition to the following benefits:

• Control over product licenses
• Stable business operations.
• Professional regulatory and post-marketing support.
• Ability to appoint multiple distributors.
• Data confidentiality.
• Unbiased advice and market insights.
• On-time regulatory intel updates.

Responsibilities

The AR must provide the following to the legal manufacturer:

• To be the legal and authorised representation at SFDA
• Submit product registration applications (MDMA)
• Products Life Cycle Management (Updates, Renewals)
• Submit Unique Device Identification (SFDA UDI)
• Clarification of SFDA regulations.
• Market Intel & insights.
• Conduct post-marketing clinical follow-up (PMCF) in Saudi Arabia.
• Post-marketing Surveillance
  • Submission of Adverse events and incidences.
  • Submission of corrective actions.
• Facilitate maintenance and global support.
• Support Shipment clearance issues.

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.
• Good access to SFDA
  For support and problem-solving.
• Supply chain planning capabilities
  E.g. for arrival schedules vs approval dates and import permits
• Work on manufacturer e-systems
  To update regulatory milestones such as registration dates, expirations, renewals, etc.
• Support SFDA inspections
• Facilitates shipment paperwork at the port.
• Resolve other in-market issues.

Low-risk classes

In the past, SFDA used to require AR for high-risk classes only. However, since 27 September 2022, AR has become mandatory on low-risk devices too. It coincided with the SFDA cancellation of the low-risk registration procedure (MDNR).

License Requirements

Here are the SFDA application requirements for an AR license:

• Valid SFDA medical device establishment license (MDEL)
• Quality management system (QMS)
• ISO 13485 Certificate for the AR Saudi company.
• Signed authorised representative agreement with the legal manufacturer.

Authorised Representative Agreement

The SFDA mandates a specific AR agreement template that needs to be signed as it is between the legal manufacturers and their Saudi authorised representative.

Here are a few essential related notes:

• Manufacturers can appoint several ARs (with conditions).
• AR Agreement must be apostilled or legalised.
• The minimum AR validity is one year.
• The AR validity matches the agreement duration or shorter.

Changing Authorised Representative

Changing the authorised representative in Saudi does not require the approval or involvement of the previous AR. The process takes one week, followed by the transfer of the medical device licenses (marketing authorisation – MDMA). Therefore, there is no need to re-register the products after transferring the AR. To learn more, you can schedule a meeting with us or send us your questions.

Fees

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

Service Charges

Contact us to receive a quotation in addition to a detailed file about AR in Saudi Arabia.

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SFDA Registration