Pure Global's Ultimate Guide: How to List Your Class I Medical Device with the SFDA in Saudi Arabia and Avoid Costly Delays

In this episode of MENA MedTech Insights, we uncover the essential steps for registering a Class I medical device in Saudi Arabia. Many companies underestimate this process, believing it to be a simple notification. We reveal why it's a comprehensive Medical Device Marketing Authorization (MDMA) that requires careful planning, local representation, and precise documentation to succeed in the Kingdom.

We break down the critical requirements set by the Saudi Food and Drug Authority (SFDA), from appointing a Saudi Authorized Representative to preparing a technical file and submitting it via the GHAD system. Learn how to avoid common pitfalls that can lead to costly delays and get your product to market faster.

A European manufacturer of Class I sterile bandages learned a hard lesson when their first shipment was held indefinitely at Saudi customs. They had a valid CE mark and a local distributor, but they lacked the two most critical components: a registered Saudi Authorized Representative and an approved MDMA from the SFDA. This oversight resulted in thousands of dollars in fees and a multi-month delay, a critical blow for a new market launch.

Key Takeaways for This Episode:
1. Why is appointing a Saudi Authorized Representative your non-negotiable first step?
2. Can you use your existing CE or FDA technical file without any changes for an SFDA submission?
3. What is the MDMA, and why is it required for even the lowest-risk devices?
4. What are the most common mistakes that lead to customs holds and market entry delays in Saudi Arabia?
5. How does the SFDA's GHAD system work, and what is your AR's role in it?
6. What specific labeling requirements must you meet for the Saudi market?
7. How can your reference market approval accelerate your SFDA application?

At Pure Global, we offer end-to-end regulatory consulting to streamline your global market access. We act as your local representative, develop your regulatory strategy, and manage your technical submissions using advanced AI tools. Let us help you navigate the complexities of the Saudi market. Contact us at [email protected] or visit https://pureglobal.com/ to learn more.