SFDA Authorized Representative in Saudi Arabia: Requirements & How to Appoint One

Foreign manufacturers cannot register or market medical devices in Saudi Arabia without an SFDA-licensed Authorized Representative. Here is what the role covers and how to appoint one.

Saudi Arabia's medical device market is one of the fastest growing in the region — but access to it runs through the Saudi Food & Drug Authority (SFDA). For any manufacturer based outside the Kingdom, the first requirement is clear: you must appoint an Authorized Representative (AR) licensed by the SFDA before you can register or sell a device.

What is an SFDA Authorized Representative?

An Authorized Representative is a locally established entity that acts as the legal bridge between a foreign manufacturer and the SFDA. The AR holds the establishment licence, submits applications on the manufacturer's behalf, and carries ongoing regulatory responsibility for the products it represents in the Saudi market.

What does the AR actually do?

How to appoint one — step by step

Appointing an AR is straightforward when you know the sequence. In practice it comes down to four stages:

1. Choose an independent AR. Many manufacturers deliberately keep the AR role separate from their distributor, so control of the registration stays with them.
2. Sign an AR agreement. A formal agreement defines responsibilities, product scope, and duration.
3. Register the establishment & products. The AR files for the establishment licence and the device authorizations (MDMA).
4. Maintain compliance. The AR keeps licences current and handles vigilance and renewals over the product lifecycle.

How 360SFDE can help

As an independent, SFDA-licensed Authorized Representative, 360SFDE manages the entire process — from establishment licensing and MDMA registration to post-market vigilance — so you can enter the Saudi market with confidence and keep control of your product registrations.