NMPA Releases August 2026 Imported Class I Medical Device Filing Information

On September 9, 2026, the National Medical Products Administration of China published the August 2026 filing information for imported Class I medical device products. This monthly release covers a total of 136 filing records, providing critical compliance intelligence for overseas manufacturers, regulatory affairs professionals, and distributors operating in the Chinese medical device market.

Key highlights from the August 2026 data:

l Changes dominate the filings — The vast majority of records (approximately 80%) are classified as “Changes,” indicating active updates to manufacturing addresses, filer names, and technical requirements. Companies such as Leica Biosystems Newcastle Ltd, Agilent Technologies, Cowellmedi, and Hu-Friedy made multiple change filings during this period.

l New valid filings — A number of products received valid (effective) filings for the first time or upon renewal. Notable examples include MTAP Antibody Reagent from Ventana Medical Systems, oral observation devices from AIOBIO, and dental surgical instruments from IBBI DENTAL INSTRUMENTS.

l Invalidated filings — Several products were marked as “Invalid,” including medical transfer boards and head immobilizers from Laerdal Medical AS, silicone rubber duplication materials from Vertex-Dental B.V., and CO₂ absorbents from AirLife Finland Oy. These typically result from voluntary cancellation, failure to renew, or reclassification.

Regulatory context:

Under the Medical Device Supervision and Administration Regulation (State Council Order No. 739) and the NMPA Announcement No. 62 of 2022, imported Class I medical devices are filed directly with the NMPA. Filing is a record-keeping process rather than an approval, but compliance remains mandatory for market access. The NMPA also continues to refine its classification catalogue through the 2026 dynamic adjustment work procedures, which now incorporate the In Vitro Diagnostic Reagent Classification Rules and updated transition period guidelines.