Authorized Representative for Medical Devices: SFDA Requirements Explained

In Saudi Arabia, the Saudi Food and Drug Authority (SFDA) requires medical device manufacturers to assign an authorized representative (AR) company to legally act on their behalf in the Saudi market. It is responsible for medical devices registration, compliance with SFDA regulations, safety, and the implementation of the required measures.

Since the authorized representative has to be a local Saudi company, legal manufacturers have two options. One is to assign their local distributor as the AR or to outsource it with a more regulatory focused company. Mostly, the strength of the local distributor is in commercialization which makes many medical devices manufacturers opt to appoint a consulting company as their authorized representative in Saudi Arabia.

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

Meaning of an Authorized Representative of a company?

It is basically a Saudi company with a signed agreement with a medical devices legal manufacturers to act on their behalf in Saudi Arabia. The authorized representative company doesn’t necessarily hold any commercial rights in the market rather facilitate the marketing and sales process by ensuring regulatory compliance.

Role of Authorized Representative

  • 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)
  • Holds an authorized representative agreement with the legal manufacturer.

SFDA Authorized Representative Agreement

The SFDA has published a specific medical device authorized representative agreement template that can be used as it is since it has the minimum required clauses. Note that:

  • The authorized representative shall have a separate agreement for each manufacturer it represents within KSA.
  • A manufacturer can appoint different AR for each medical device category or group, therefore different 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 two years. Note that the validity of the issued AR license 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.

AR License Fees:

The SFDA license fee for authorized representative is SAR 2600/year (USD 693.33)

Traits of a Good Authorized Representative

  • Complete coverage of authorized representative basic duties (Compliance assurance, safety monitoring, etc.)
  • Prompt update of legal manufacturer system with 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 devices manufacturers and affiliates with good communication skills.

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