Maintaining market access in Saudi Arabia is even more challenging than gaining initial approval. The SFDA's post-market surveillance (PMS) requirements are rigorous and demand a proactive, systemic approach. Many international manufacturers are caught off guard by the depth of these expectations, risking compliance actions that could jeopardize their presence in one of the largest MedTech markets in the MENA region. This episode of MENA MedTech Insights provides a deep dive into the SFDA’s core requirements for Post-Market Surveillance. We unpack how the foundational Quality Management System guidance, MDS-G35, dictates the entire framework for your PMS activities. From strict incident reporting timelines to the nuances of trend analysis and corrective actions, we provide the critical details you need to ensure your device remains safe, effective, and compliant long after its market launch. **A Case of Missed Signals:** Imagine a European manufacturer of a Class C cardiovascular stent successfully launches in Saudi Arabia. Six months later, they receive scattered reports from hospitals about minor deployment difficulties. Without a robust PMS system aligned with SFDA's expectations, these early signals are dismissed as isolated user errors. The issue escalates into a pattern, leading to a major Field Safety Corrective Action, a damaged reputation with key opinion leaders, and a full SFDA audit. This is a common pitfall for companies that underestimate the SFDA's rigorous post-market oversight, a costly mistake that could have been prevented. **Key Takeaways From This Episode:** * Why is SFDA's MDS-G35 more than just a QMS checklist for your PMS plan? * What are the critical timelines for reporting adverse events in Saudi Arabia, and what are the consequences of missing them? * How can you effectively distinguish between an isolated user complaint and a reportable trend? * What specific documentation must your Authorized Representative in Saudi Arabia maintain to be PMS compliant? * For a Class C or D device, what are the SFDA's core expectations for a Periodic Safety Update Report (PSUR)? * How does a failure in your Corrective and Preventive Action (CAPA) process directly violate SFDA post-market surveillance rules? * What is the single biggest mistake foreign manufacturers make regarding post-market surveillance in the Kingdom of Saudi Arabia? At Pure Global, we believe market access is just the beginning. Our end-to-end regulatory solutions cover the entire product lifecycle, including robust post-market surveillance and vigilance. We combine local Saudi Arabian expertise with advanced AI tools to ensure you maintain compliance and market presence seamlessly. Stop reacting and start proactively managing your post-market obligations. Contact us at [email protected] or visit https://pureglobal.com/ to learn how we can be your local regulatory partner in the MENA region.