May 11, 2021

China’s National Medical Products Administration (NMPA) has released new findings showing a substantial increase in the number of medical device adverse event reports for 2020.

According to the regulator’s Annual Report on the Monitoring of Adverse Events of Medical Devices (2020) (link in Chinese), the number of adverse event reports submitted to the National Medical Device Adverse Event Monitoring Information System last year increased by more than 35%, from 396,345 reports in 2019 to 536,055 reports in 2020.

Emergo by UL consultants in Beijing note NMPA’s recent improvements to its adverse event reporting system as well as guidance for adverse event monitoring (link in Chinese) issued in April 2020 as contributing factors for the marked increase in reporting.

Class II devices accounted for most adverse events in 2020

The NMPA data shows that Class II medical devices accounted for more than 45% of all adverse event reports over the course of 2020, while Class III higher-risk devices made up 33% of such reports. Furthermore, a majority of adverse event reporting (nearly 65%) pertained to passive devices last year.

Given the relative newness of the NMPA adverse event reporting system, the regulator’s annual report also includes reminders on how to properly register and maintain their user information in the system; report qualifying medical device adverse events; and track and process related device information.

Learn more about Chinese medical device regulations at Emergo by UL:

  • China NMPA medical device registration consulting
  • Chinese medical device clinical and testing requirements assessment
  • Whitepaper: China NMPA registration requirements
  • Webinar: Medical device registration in China

 

 

 

Author

  • Stewart Eisenhart

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