Medical Device Authorised Representative in Saudi Arabia (SFDA)

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 the local representative responsible for regulatory activities such as medical device registration and postmarketing surveillance.

Appointing an authorised representative requires submitting a signed agreement to the SFDA. It is a fast process, and the manufacturer can change the authorised representative similarly. Here are a few initial 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 and marketing.
• 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 manufacturer in Saudi Arabia. SFDA requires companies to appoint an AR before registering their product; the AR is not necessarily the distributor.

Independent AR v.s Distributor as AR

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

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

Most legal manufacturers prefer to appoint an independent AR as it is the best option in Saudi, similar to the common practice in the EU.

Independent AR advantages

Paying an annual fixed fee for an independent AR without any commission on shipments provides manufacturers with a group of advantages, such as:

• Advanced regulatory and post-marketing support.
• Ability to register multiple brand names for the same product.
• Ability to ship goods to multiple distributors/Importers.
• Stable business operations.
• Control over product licenses
• Data confidentiality.
• Unbiased advice and market insights.
• On-time regulatory intel.
• High Communication skills.

Responsibilities

The AR must provide the following to the legal manufacturer:

• Legal, authorised representation at SFDA
• Regulatory Support
• Submit the Unique Device Identification (SFDA UDI)
• Clarification of SFDA regulations
• Market Intel & insights
• MDMA Updates
• Post-marketing Surveillance
  • Reporting adverse events and incidences
  • Submission of corrective actions
  • Conduct post-marketing clinical follow-up (PMCF) in Saudi Arabia
• Facilitate device maintenance
• Support shipment clearance issues

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.
• 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 cancellation of the low-risk registration procedure (MDNR).

License Requirements

Here, we list the SFDA requirements for a local company to act as an authorised representative:

• A Saudi company with a Commercial Record (CR) of medical device activity.
• Availability of a Quality management system (QMS)
• A valid ISO 13485 certificate.
• Pass SFDA inspection
• A valid SFDA medical device establishment license (MDEL)
• Dedicated staff for safety and regulatory functions.
• Signed authorised representative agreement with the legal manufacturer.

AR 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 Your Authorised Representative

Changing the authorised representative in Saudi does not require approval from the previous AR. The process takes 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 authorised representative certificate is SAR 2,600/year (USD 693.33). For more details about SFDA charges, refer to our article: SFDA Fees.

Authorised Representative Provider

PharmaKnowl is an SFDA-licensed authorised 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 to receive a proposal. You can also schedule a meeting with us to answer your questions.

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