Navigating MedTech in Malaysia: A Deep Dive into Post-Market Surveillance and Vigilance Requirements with Pure Global's ASEAN Insights

In this episode of ASEAN MedTech Insights, we explore the essential post-market surveillance and vigilance requirements for medical devices in Malaysia. We break down the key regulations under the Medical Device Act 2012 and explain the critical obligations for manufacturers and importers to ensure ongoing patient safety and market compliance.

We delve into the practical steps companies must take, from maintaining meticulous distribution records to handling mandatory problem reporting. For example, consider a scenario where a software bug in a widely used infusion pump leads to dosing errors. We discuss the immediate actions the authorized representative must take, the strict reporting timelines to the Medical Device Authority (MDA), and how to execute an effective Field Safety Corrective Action to protect patients and maintain market trust.

Key Takeaways from this Episode:
- What are the two primary pieces of legislation governing post-market surveillance in Malaysia?
- Why are detailed distribution records non-negotiable for MedTech companies in the Malaysian market?
- What specific events trigger the need for a Mandatory Problem Report to the MDA?
- What is the typical timeframe for reporting a serious public health threat?
- How does a Field Safety Corrective Action (FSCA) work in practice?
- What are the critical responsibilities of a local Authorized Representative in the vigilance process?
- How can proactive post-market surveillance protect both your brand and patient lives?

At Pure Global, we specialize in providing end-to-end regulatory consulting for MedTech and IVD companies. Our local experts in Malaysia and across ASEAN can act as your authorized representative, manage your vigilance system, and ensure you remain compliant with all post-market requirements. Streamline your global market access with our blend of local expertise and advanced AI tools. Contact us at [email protected] or visit https://pureglobal.com/ to learn more.