China IVD and Medical Device Update

In mid-May, the Chinese NMPA issued a new IVD Reagent Classification Catalogue. The new catalogue has over 25 primary product varieties and over 1,800 secondary varieties. A number of specific reagent sub-categories are further defined including staining solutions, cell culture media, etc. IVD reagent certificates received before January 1, 2025, will still be valid until the renewals are required. All new registrations will follow the new classification catalogue in the new year. Applications in process will still be reviewed under the old IVD reagent classification system. Under the new classification system, some IVD reagents will be up-classified and some down classified and companies need to follow up as needed.

In April, the NMPA outlined a new requirement for enhanced supervision for medical device production for medical device applicants or registrants. This new regulation will become a law on June 1, 2024. Basically, device registrants need to take more oversight and care including things like – 1. quality agreements, 2. critical raw materials, 3. Contamination risks, etc. In addition, registrants using contract manufacturers must consolidate their manufacturing processes into their quality systems, perform more audits of suppliers and include more details on contract manufacturers they utilize in their device applications.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.