China’s National Medical Products Administration (NMPA) has issued a new announcement that refines how medical devices and in vitro diagnostic (IVD) reagents are classified and managed when classification changes occur. Announcement No. 52 establishes new guidance for handling classification adjustments. It is intended to address a long-standing regulatory challenge: determining what actions manufacturers must take when a product’s classification changes.
Under the new framework, products reclassified to a higher-risk category must obtain approval under the new classification within an established transition period. The NMPA clarified that transition periods will generally be two years for products that do not require clinical trials and three years for those that do. In special circumstances, transition periods may extend beyond three years but generally may not exceed five years.
The announcements also clarify how registration renewals, pending applications, and product changes should be handled during reclassification. In addition, registrants are required to cancel their original registration certificates once a new certificate under the revised classification is issued. This requirement will require closer coordination between overseas manufacturers and their local Chinese distributors/agents.
The new guidance took effect immediately upon publication and is expected to provide greater regulatory consistency and predictability for manufacturers navigating future device classification changes in China.
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.