Medical Device Authorized Representative (SFDA AR)

In Saudi Arabia, the Saudi Food and Drug Authority (SFDA) requires medical device legal manufacturers to appoint an authorized representative (AR) to act on their behalf in the market at all times. The AR will be responsible for medical device registration, compliance with SFDA regulations, safety, and the implementation of the required regulatory standards.

An expired AR will trouble the shipment clearance at the port so it is best to closely monitor its validity. When needed, changing the authorized representative can be done without the involvement of the previously appointed AR.

In this post, we’ll discuss the definition of AR, its role, and how to appoint one for your company.

What is an Authorized Representative?

A Saudi company that holds a signed agreement with a medical device legal manufacturer to act on its behalf in Saudi Arabia. The authorized representative has to be registered and approved by the SFDA and doesn’t necessarily hold any commercial rights in the market; it facilitates the marketing and sales process by ensuring regulatory compliance.

Who can be an AR in Saudi?

Authorized representatives in Saudi Arabia must be based in Saudi and have specific licenses and qualifications. Here are the most important requirements:

  • A local Saudi company with a commercial record reflecting medical device activities.
  • Licensed by SFDA as a medical device establishment.
  • ISO 13485 certified
  • Having dedicated staff for safety and regulatory functions.

Independent AR v.s Distributor as AR

Most legal manufacturers choose to appoint an independent AR (e.g. consulting office) instead of appointing their commercial distributor or importer as their AR. This is because the independent AR provides the following:

  • More control for the legal manufacturer over their business in the Saudi market.
  • Unbiased and commercially neutral relationship.
  • Enables legal manufacturers to market, sell, and ship, to multiple importers in Saudi.
  • Professional regulatory and post-marketing support.
  • Data confidentiality.

Is AR needed for all medical devices?

Yes, it is required for all medical devices. Starting from 27/9/2022, the AR became mandatory for all companies regardless of their medical device risk class. It is only required for high-risk medical devices. Therefore, low-risk Class 1 (A) devices do not require the appointment of a local authorized representative in Saudi Arabia.

AR Role

  • Representation at SFDA
  • Marketing authorization submission and maintenance for medical devices.
  • Listing other Medical Devices
  • Implementation of SFDA requested actions.
  • Provision of data to SFDA related to quality, efficacy, and safety.
  • Postmarketing Surveillance
    • Submission of Adverse actions that occurred outside the country
    • Submission of any required corrective action resulting from the ongoing surveillance.
    • Involvement with other parties responsible for medical device installation, maintenance, and supply.

AR Licensing Requirments

  • Local Saudi Company
  • Establishment National Registry Number (MDNR)
  • Valid SFDA establishment license for medical devices activity (MDEL)
  • Quality management system (QMS) and ISO 13485
  • Holds an authorized representative agreement with the legal manufacturer.

SFDA Authorized Representative Agreement

The SFDA requires signing a specific agreement template for the medical device authorized representative. The legal manufacturers and local Saudi companies can sign it as-is since it has the minimum required clauses.

Note that:

  • The authorized representative shall have a separate agreement for each legal manufacturer.
  • A manufacturer can appoint a different AR for each medical device category or group, therefore separate agreements.
  • Once the AR Agreement is signed, it must be legalized by both parties in their respective countries.

The validity of the AR agreement is a minimum of one year. Note that the issued AR license’s validity cannot be longer than the validity of the AR Agreement. The applicant can submit an AR application for the validity of one year, two years & so on, and the fees are charged accordingly.

Changing AR in Saudi Arabia

Changing the authorized representative in Saudi can be done without the involvement of the previously appointed AR. It is a process that takes 2 weeks and is followed by the transfer of the associated medical device marketing authorization (MDMA) licenses.

AR License Fees

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

Traits of good AR company

  • Complete coverage of authorized representative basic duties (Compliance assurance, safety monitoring, etc.)
  • Prompt update of the legal manufacturer system with the regulatory milestones such as registration dates, expirations, renewals, etc.
  • Prompt sharing of regulatory updates with the ability to identify impact area and level.
  • Good legal accessibility to the authorities for support and problem-solving.
  • High planning capabilities with the supply chain to ensure securing import permits on time.
  • Ability to liaise with global medical device manufacturers and affiliates with good communication skills.

Looking for an Authorized Representative in Saudi?

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