In 2026, China’s NMPA has intensified its overseas inspections of medical device manufacturers, with 33 companies targeted for unannounced on-site or remote audits. The new version of the Medical Device Good Manufacturing Practice (GMP) will take effect in November 2026, emphasizing data authenticity, lifecycle traceability, risk management, and contract manufacturing controls. Several overseas companies have already faced import suspensions due to compliance failures. To maintain market access, overseas manufacturers are advised to proactively conduct self-audits, respond quickly to inspection notices, and implement corrective actions. Consulting support is available to help navigate the stricter regulatory landscape.
