On August 17, the NMPA announced that its classification catalog would be adjusted given the influx of new innovative devices. Fifty-eight product categories have been updated. However, only 4 product categories have been changed from Class 1 to Class 2 or from Class 2 to Class 3 due to increased risks according to clinical experts. 8 product categories have been changed to lower classification from Class 3 to Class 2 or from Class 2 to Class 1 likely due to clinical data that supports these products’ safety and effectiveness. Finally, 8 product categories have been added as Class 3 devices. The remaining 38 product categories only have product description changes, but no classification change.
For products that are now classified in a higher class, a change approval will need to be done before December 31, 2025, or they will not be able to be imported and sold in China. For products that are changed to a lower class, their original approvals will be valid until their existing registration expires. Then the new lower classification will be listed on their renewal application. For products with no classification changes and only a product description change, the device manufacturer can make their own decision on when to implement this or combine it with other changes via notification. Any new application starting from August 15, 2023, should follow this updated classification catalog including items 01-01-03 and 01-10-06.
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.
Source used in the article: http://english.nmpa.gov.cn/2019-10/11/c_415411.htm