In this episode of MENA MedTech Insights, we provide a crucial guide to the post-market surveillance (PMS) requirements for medical devices in Qatar. As one of the fastest-growing healthcare markets in the Gulf Cooperation Council (GCC), Qatar's regulatory environment, overseen by the Ministry of Public Health (MOPH), demands rigorous post-market vigilance from manufacturers to ensure patient safety and maintain market access. We move beyond theory to break down the essential components of a compliant PMS system in Qatar. This includes mandatory adverse event reporting timelines, the process for initiating Field Safety Corrective Actions (FSCAs), and the importance of proactive data collection. We explore how global standards, like the EU MDR, influence Qatari expectations and highlight the critical role of a local authorized representative in navigating the specific requirements of the MOPH. This episode is a must-listen for regulatory affairs professionals, MedTech startups, and global enterprises planning to operate in Qatar. **Case Highlight:** Imagine your company's new cardiac stent is successfully launched in Qatar, but six months later, you discover a minor manufacturing defect that could, under specific conditions, increase the risk of thrombosis. You have the data, but what is the first step you must take in Qatar? The clock is ticking, and a misstep in reporting to the MOPH could jeopardize your entire market presence. We walk you through the critical actions required in this high-stakes scenario. **What You'll Learn (本期干货):** 1. What are the specific timelines for reporting serious adverse events to Qatar's MOPH? 2. How is a "serious incident" defined under Qatari medical device regulations? 3. What are the essential elements of a Field Safety Notice (FSN) that the MOPH expects to see? 4. Why is your local authorized representative your most critical partner for post-market compliance in Qatar? 5. Are Periodic Safety Update Reports (PSURs) a mandatory requirement for all device classes in Qatar? 6. How can your existing EU or FDA post-market data be leveraged for Qatari compliance? 7. What are the most common PMS mistakes foreign manufacturers make when entering the Qatari market? 8. What is the difference between a proactive PMS plan and a reactive vigilance system? 9. How do you manage the logistics of a device recall or correction within Qatar's healthcare system? 10. What are the penalties for non-compliance with post-market surveillance duties? At Pure Global, we specialize in transforming these complex regulatory challenges into clear, actionable strategies. We offer end-to-end regulatory consulting, acting as your local representative and using advanced AI tools to ensure your MedTech and IVD products achieve and maintain compliance in over 30 markets, including the MENA region. Let us handle the regulatory maze so you can focus on innovation. Contact us at [email protected] or visit https://pureglobal.com/ to learn more.