Device classification in China can sometimes be a tricky issue. If the classification is unclear, device companies can submit an online application to determine the classification. After the online submission, the applicant needs to submit hard copy documents and gain acceptance and pre-review from the NMPA. The NMPA will review and make a final determination of classification within about 25 working days.
The Chinese NMPA announced a new classification notice in mid-July to enhance their current classification system. While this announcement had a number of new objectives, some of the key objectives included – 1. Improving the classification technology committee, 2. Revising and improving the classification catalog, 3. Improving training and education on device classification, 4. upgrading the development of information technology for device classification, etc.
In addition, in mid-July, the NMPA Medical Standardization Administration outlined the second group of their 2023 Medical Device Classification findings. This report outlines about 200 medical devices and their specific classifications as a result of inquiries from both domestic and foreign device manufacturers.
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.