Medical Device Authorized Representative: SFDA Requirements

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In Saudi Arabia, the Saudi Food and Drug Authority (SFDA) requires medical device manufacturers to assign an authorized representative (AR) company to act on their behalf in the Saudi market legally. AR is responsible for the medical device 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 to be the AR or outsource it with a more regulatory-focused company.

In most cases, the local distributor is commercial focused without dedicated regulatory professionals, making many medical device manufacturers opt to appoint a consulting company as their authorized representative in Saudi Arabia. The latter option provides more power for the legal manufacturer and freedom in the market.

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

What is an Authorized Representative?

It is basically a Saudi company with a signed agreement with 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 facilitates the marketing and sales process by ensuring regulatory compliance.

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

SFDA Authorized Representative Agreement

The SFDA requests a specific agreement template for the medical device authorized representative that legal manufacturers and local Saudi companies can sign as-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 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.

AR License Fees:

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

Traits of a Good AR Company

  • 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 device manufacturers and affiliates with good communication skills.

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