SFDA Authorized Representative (AR) for Medical Devices

Need to Register Your Medical Device in Saudi Arabia?

As an overseas manufacturer, your first essential step is appointing a local Authorized Representative (AR) that holds a valid AR license. This supports compliance with the applicable Saudi FDA (SFDA) requirements and gives you a licensed local channel for dealings with the authority.

The AR must be a legal entity under Saudi regulations and hold a valid SFDA licence, obtained separately for each manufacturer it represents. That licence has to be in place before a marketing authorization application is submitted through the AR.

Once your AR mandate is in place, Bio-Standards can proceed with Medical Device Marketing Authorization (MDMA) for your devices.

We Simplify Your AR Selection:

Bio-Standards, your Saudi FDA regulatory experts, can serve as your trusted Authorized Representative (AR). We handle both types of AR mandate:

- Single-Site AR Agreement: An AR agreement between the manufacturer and Bio-Standards, used when the products to be registered are manufactured at a single site.

- Multiple-Site AR Agreement: An AR agreement between the manufacturer and Bio-Standards, used when the products to be registered are manufactured at more than one site. All sites must be listed in the AR agreement.

Saudi FDA Authentication Made Easy

1. If the legal manufacturer is located outside the Kingdom of Saudi Arabia, the agreement must be authenticated as follows:

If the country is a member of the Hague Convention:

An “Apostille” issued by an accredited body in the foreign country.

If the country is not a member of the Hague Convention:

A) Chamber of Commerce in the foreign country.

B) The Ministry of Foreign Affairs in the foreign country.

C) The Saudi embassy in the foreign country.

D) The Saudi Ministry of Foreign Affairs.

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2. If the legal manufacturer is located within the Kingdom of Saudi Arabia, the agreement must be authenticated by all of the following parties:

A) The Chambers of Commerce and Industry.

B) The Embassy of the foreign party in the Kingdom.

C) The Saudi Ministry of Foreign Affairs.

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What an Authorized Representative does

An SFDA Authorized Representative is a locally licensed entity that represents an overseas manufacturer before the Saudi Food and Drug Authority. The role covers the full lifecycle, not just the initial submission:

• Regulatory compliance. Ensuring devices meet SFDA requirements and working directly with the authority.
• Documentation and labeling. Confirming technical files, declarations, and product labels meet local requirements. For devices intended for lay users, the information supplied by the manufacturer must be in both Arabic and English.
• Communication with the SFDA. Acting as the manufacturer’s point of contact for registration, renewal, and post-market matters.
• Post-market surveillance and vigilance. Monitoring device performance in the market and reporting adverse events through NCMDR.
• Facilitating registration. Managing the Medical Device Marketing Authorization (MDMA) application.

Working with your distributors

The AR and your distributors are separate roles. Distributors need their own establishment licence (MDEL) and must coordinate with the manufacturer’s AR, including confirming the AR is properly registered with the SFDA and supporting the documentation required for marketing authorization. The SFDA does require that no more than one Authorized Representative is appointed for the same type or general group of medical devices, so the AR appointment is worth planning alongside your distribution arrangements.

AR licensing is the first step in our medical device registration services in Saudi Arabia. For a step-by-step overview, download the Authorized Representative licensing e-book, or contact Bio-Standards to appoint us as your AR.

Focus on Your Business, We Handle the Rest

Let Bio-Standards navigate the complexities of Saudi FDA registration. We’ll be your one-stop partner for AR selection, authentication, and a smooth, fully compliant registration process.

Your AR Mandate, Built to Saudi FDA Requirements

Our in-depth regulatory knowledge means your AR mandate is structured against current Saudi FDA requirements from the outset. We also manage the entire authentication process, saving you time and effort.