China’s National Medical Products Administration (NMPA) has released six new guidelines to strengthen post-market surveillance and vigilance for medical devices. The updates set clearer expectations for quality management and require manufacturers and local agents (Marketing Authorization Holders) to have systems in place to monitor, assess, and respond to adverse events. They also include inspection guidance that gives companies a better idea of what regulators will focus on, especially when it comes to maintaining clear and traceable records throughout the product’s lifecycle.
A key theme across the guidelines is a stronger push for proactive risk management through Trend Reports and Periodic Safety Update Reports (PSURs). Device companies are expected to actively watch for unusual patterns, such as increases in how often or how serious adverse events become. For Class II and Class III devices, PSURs must be submitted annually within 60 days of the registration anniversary. These reports are meant to bring together data from clinical follow-ups, adverse event monitoring, and global safety updates to show how the product’s benefit-risk profile is evolving.
The guidelines also provide more detail on how adverse event assessments and periodic risk reviews should be handled. There is a clear effort to improve the quality of submissions, especially in areas that have caused issues in the past, like missing data or overly basic analysis. Device companies will need to take timely action, such as updating their instructions or initiating recalls, when safety concerns come up.
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.