SFDA Authorized Representative (AR) for Medical Devices in Saudi Arabia

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 ensures full compliance with Saudi FDA (SFDA) regulations.

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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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.

Guaranteed Compliance with Saudi FDA Requirements

Our in-depth regulatory knowledge ensures your AR mandate fulfills all Saudi FDA requirements. We also manage the entire authentication process, saving you time and effort.

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.

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