Who are we

An independent regulatory partner for the Saudi market.

IREG (Intelligent Regulations Medical) is an independent Authorized Representative and medical device regulatory service provider in Saudi Arabia, licensed in the Kingdom and certified to ISO 13485:2016.

Who we are

SFDA specialists, not generalists.

Our team brings years of hands-on experience with the requirements of the Saudi Food & Drug Authority (SFDA). We act as an Authorized Representative for overseas manufacturers and as a regulatory partner for local companies, across medical devices, food and cosmetics.

Every engagement is run by a named project manager, under written procedures and the same quality standard we help our clients achieve.

About us

More about IREG.

Mission, vision & values

What we set out to do, where we are heading, and the six values behind every submission.

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Why IREG

Six reasons manufacturers choose IREG as their Saudi regulatory partner.

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Quality

We work to ISO 13485:2016, the standard we help our clients reach.

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Our commitment

Transparency, accountability and a dedicated manager you can always reach.

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Credentials

Our SFDA licences, ISO certification and Saudi commercial registration.

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The IREG advantage

Everything a manufacturer needs from one regulatory partner.

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Start with step one

Book an initial consultation.

Tell us about your portfolio and timeline. A specialist will map the regulatory pathway with you.

Talk to a specialistinfo@i-regulations.com
+966 53 530 0129