China Releases New Medical Device Guidelines

On April 4, China’s NMPA promulgated 2023 new medical device registration guidelines. These guidelines affect product registration, type testing, clinical trials, etc. The guidelines for Class 3 medical devices include 36 new guidelines and 27 revisions. Examples of Class 3 products with new guidelines include Hemodialysis equipment and Nitric oxide instruments. For Class 2 medical devices, there are 23 new guidelines and 32 revisions.  Examples of Class 2 products with new guidelines include laser positioning systems and gas alarm systems.

China’s NMPA looks for feedback from medical device companies, relevant trade associations, and other concerned parties on these new device guidelines. These new medical device guidelines show China’s continuing efforts to make medical device regulations more transparent.


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:https://practiceguides.chambers.com/practice-guides/healthcare-medical-devices-2023/china/trends-and-developments