China NMPA GMP 2026: Preparing for Stricter Quality System Requirements

Medical Device Global Market Access · Oct 26, 2026 · 5m

China's National Medical Products Administration (NMPA) is enforcing a revised Good Manufacturing Practice (GMP) for medical devices starting November 1, 2026. This episode provides a practical guide for quality and regulatory teams on how to prepare for this first major update since 2014. We cover the stricter requirements for lifecycle risk management, supplier controls, and contract manufacturing (entrusted production), and outline the concrete steps manufacturers must take to ensure their quality management systems are compliant by the deadline to avoid enforcement actions. Key Questions…