Your 360° partner for
SFDA compliance in Saudi Arabia
We help international manufacturers register products, appoint an Authorized Representative, and reach the Saudi market faster — with full SFDA compliance at every step.
Trusted by manufacturers worldwide
End-to-end regulatory services for the Saudi market
From classification and registration to representation and post-market compliance — one partner across the full product lifecycle.
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A complete path to SFDA approval
Four clear stages take your product from first assessment to a maintained, market-ready registration.
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Deep expertise. Tailored support. Real results.
Our team has more than 15 years of experience and knows the SFDA landscape inside out. We turn complex requirements into a clear plan — reducing delays, managing submissions, and protecting your time to market.
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The latest from 360SFDE
SFDA Authorized Representative: requirements & how to appoint one
Foreign manufacturers cannot market devices in Saudi Arabia without a licensed AR. Here's what the role covers.
The SFDA drug approval framework, explained
A plain-language overview of registration pathways, timelines, and what reviewers expect.
ISO 13485 essentials every manufacturer should know
The quality-system foundations that make SFDA submissions smoother and audits easier.
It has been a pleasure working with 360SFDE. The team is responsive, professional, and deeply committed to our deadlines — a reliable partner for our registrations in Saudi Arabia.
Ready to enter the Saudi market?
Book a free consultation with our regulatory specialists. We'll map your pathway to SFDA approval and market access.
Kingdom of Saudi Arabia