China NMPA Post-Market Vigilance 2026: New Rules for Foreign Manufacturers

This episode provides a detailed analysis of China's NMPA new post-market vigilance framework, released on June 12, 2026. We discuss the mandatory, risk-based system that introduces new obligations for foreign medical device manufacturers, including detailed requirements for trend reporting, Periodic Safety Update Reports (PSURs), and comprehensive vigilance planning. Learn about the immediate compliance steps your company must take to maintain market access in China. Key Questions: - What are the key components of China's new post-market vigilance framework? - How does the NMPA's 2026 update affect overseas medical device manufacturers? - What are the new requirements for Periodic Safety Update Reports (PSURs) in China? - What is trend reporting and how must it be implemented under the new NMPA rules? - What specific actions should regulatory teams take to ensure compliance with these changes? - How does the risk-based approach change post-market surveillance obligations in China? - What is the role of the China Agent in this new vigilance system? - Are there immediate deadlines for implementing these new vigilance plans? Sources: - https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQGLsm9oWY0mwgxGjOzXpOhnX6mb_eSYMd2eJdGyRW0KTBfhCtttdPOeRD_8Nzyq12FBpBPa4wS6BUSh2s2v_RM1MEMGAW5cSZriDznF0Hal8q-yufaFLrzpxl-HiaKZ7gNmqblkfoIwzbba8Mf0L816TbpmNJLGIJzzqf6rbXvJCSw= How Pure Global can help: Navigating China's complex regulatory landscape requires local expertise and a proactive strategy. Pure Global provides end-to-end support for MedTech and IVD companies, from initial registration to post-market surveillance and vigilance compliance. Our in-country experts in China can act as your legal agent, help you develop an NMPA-compliant vigilance plan, and manage your reporting obligations. We leverage advanced AI tools to streamline dossier preparation and monitor regulatory changes, ensuring you maintain compliance and market access. Visit https://pureglobal.com or contact us at [email protected] to learn more. Explore our free AI tools and regulatory database at https://pureglobal.ai.