According to MDCLOUD statistics, a total of 15,071 medical device products were registered for the first time nationwide in 2022, an increase of 1,345 compared with 13,726 in 2021, with a year-on-year growth of 9.8%.

01 General Summary

On January 10, the NMPA issued the Announcement on Approving the Registration of 339 Medical Device Products (December 2022) (No. 4, 2023).

Beijing Municipal Drug Product Admintration recently issued the Guiding Principles for Optimization and Verification of Beijing Medical Device Registration Quality Management System (Trial) and the Guiding Principles for Suspension of Inspection of Beijing Medical Device Registration Quality Management System (Trial).

Q: If multiple single-free clinical trial in vitro diagnostic reagents are combined into multiple joint testing products, can they be exempted from clinical trials?，

In November 2022, NMPA approved 172 medical devices, including 22 Class III imported products, 29 Class II imported products, and 121 Class III domestic products.