NMPA Releases September 2026 Filing Information for Imported Class I Medical Devices

On October 12, 2026, China's National Medical Products Administration officially released the filing information for imported Class I medical devices for September 2026.

According to official data, the NMPA approved a total of 311 filing items for imported Class I medical devices in September 2026. This includes 41 new filings, 217 changes to existing filings, and 53 cancellations.

Key observations from this month's data are as follows. In terms of new filings, the products covered include gene deletion probe kits, antibody reagents, dental instruments, orthopedic fixators, and surgical fixation devices, with filers including international companies such as Abbott Molecular, Leica Biosystems, SPORLASTIC, and SEPTODONT. Changes to filings reached 217 items, accounting for nearly 70% of the total, indicating that a significant number of previously filed imported products are undergoing information updates or adjustments. A total of 53 filings were cancelled.

The continuous updates to filing information reflect the NMPA's ongoing implementation of the "filing plus post-market supervision" model for imported Class I medical devices. For professionals engaged in medical device registration and regulatory affairs, tracking monthly filing updates can help identify product access trends and changes in compliance requirements.