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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.

The medical device technical team of CIRS Group was invited to attend the event, and jointly held a special seminar on FDA & CE MDR Certification and NMPA Clinical Evaluation with the organizer. Empowering Chinese, Korean and global medical device enterprises to comply with regulations and expand overseas with professional regulatory services, CIRS Group has gained high attention and wide recognition from the industry.

In order to help Korean companies that want to export cosmetic medical devices to China, the Korea Medical Device Industry Association and CIRS Group Korea will hold a seminar on the Development Trends and Registration Process for Cosmetic Medical Devices in China.