China NMPA's Revised GMP: What Manufacturers Must Do by the November 2026 Deadline

Podcast: Medical Device Global Market Access · Pure Global

Opublikowano: 2026-10-08

China's National Medical Products Administration (NMPA) is enforcing a revised Good Manufacturing Practice (GMP) for medical devices, with a compliance deadline of November 1, 2026. This episode explores the first major update to China's quality system regulations since 2014, detailing the stricter requirements for risk management, supplier controls, and contract manufacturing. We also discuss the NMPA's recent increase in enforcement actions against foreign manufacturers and provide practical steps for quality and regulatory teams to prepare for the deadline. Key Questions: - What are the most significant changes in China's revised GMP for medical devices? - When is the final deadline for manufacturers to...